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Therapeutic Goods Act 1989

Authoritative Version
Act No. 21 of 1990 as amended, taking into account amendments up to Federal Circuit and Family Court of Australia (Consequential Amendments and Transitional Provisions) Act 2021
An Act relating to therapeutic goods
Administered by: Health
Registered 27 Sep 2021
Start Date 01 Sep 2021
Table of contents.

Commonwealth Coat of Arms of Australia

Therapeutic Goods Act 1989

No. 21, 1990

Compilation No. 81

Compilation date:                              1 September 2021

Includes amendments up to:            Act No. 13, 2021

Registered:                                         27 September 2021

This compilation is in 2 volumes

Volume 1:       sections 1–41A

Volume 2:       sections 41B–69

                        Endnotes

Each volume has its own contents

About this compilation

This compilation

This is a compilation of the Therapeutic Goods Act 1989 that shows the text of the law as amended and in force on 1 September 2021 (the compilation date).

The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of provisions of the compiled law.

Uncommenced amendments

The effect of uncommenced amendments is not shown in the text of the compiled law. Any uncommenced amendments affecting the law are accessible on the Legislation Register (www.legislation.gov.au). The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. For more information on any uncommenced amendments, see the series page on the Legislation Register for the compiled law.

Application, saving and transitional provisions for provisions and amendments

If the operation of a provision or amendment of the compiled law is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes.

Editorial changes

For more information about any editorial changes made in this compilation, see the endnotes.

Modifications

If the compiled law is modified by another law, the compiled law operates as modified but the modification does not amend the text of the law. Accordingly, this compilation does not show the text of the compiled law as modified. For more information on any modifications, see the series page on the Legislation Register for the compiled law.

Self‑repealing provisions

If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.

  

  

  


Contents

Chapter 4—Medical devices                                                                               1

Part 4‑1—Introduction                                                                                                       1

Division 1—Overview of this Chapter                                                                1

41B....... General................................................................................................ 1

41BA.... Requirements for medical devices (Parts 4‑2 and 4‑3)........................ 1

41BB..... Administrative processes (Parts 4‑4 to 4‑10)...................................... 1

41BC..... Enforcement (Part 4‑11)...................................................................... 2

Division 2—Interpretation                                                                                         3

41BD.... What is a medical device..................................................................... 3

41BE..... Kinds of medical devices..................................................................... 5

41BEA.. Excluded purposes.............................................................................. 6

41BF..... System or procedure packs................................................................. 6

41BG.... Manufacturers of medical devices....................................................... 6

41BH.... Meaning of compliance with essential principles................................ 7

41BI...... Meaning of non‑application of conformity assessment procedures..... 8

41BIA... Meaning of non‑application of overseas requirements comparable to conformity assessment procedures               8

41BIB... Overseas regulators............................................................................. 9

Division 3—Application provisions                                                                     10

41BJA... Application of this Chapter to a biological........................................ 10

41BK..... Application of the Criminal Code..................................................... 11

Part 4‑2—Essential principles and medical device standards                   12

41C....... What this Part is about...................................................................... 12

Division 1—Essential principles                                                                            13

41CA.... Essential principles............................................................................ 13

Division 2—Medical device standards                                                               14

41CB..... Medical device standards.................................................................. 14

41CC..... Content of medical device standards................................................. 14

41CD.... Inconsistencies between medical device standards............................ 15

Division 3—Database of unique device identifiers of medical devices 16

41CE..... Database of unique device identifiers of medical devices.................. 16

Part 4‑3—Conformity assessment procedures                                                   18

41D....... What this Part is about...................................................................... 18

Division 1—Conformity assessment procedures                                          19

41DA.... Conformity assessment procedures................................................... 19

41DB.... Medical device classifications........................................................... 20

Division 2—Conformity assessment standards                                             21

41DC.... Conformity assessment standards..................................................... 21

41DD.... Content of conformity assessment standards.................................... 21

41DE..... Inconsistencies between conformity assessment standards............... 22

Part 4‑4—Conformity assessment certificates                                                    23

41E........ What this Part is about...................................................................... 23

Division 1—Issuing conformity assessment certificates                           24

41EA..... When conformity assessment certificates are required...................... 24

41EB..... Applications...................................................................................... 24

41EC..... Considering applications................................................................... 25

41ECA.. Conformity assessment (priority applicant) determinations............... 27

41ED..... Time for making decisions on applications....................................... 29

41EE..... Procedure following making a decision whether to issue certificate.. 29

41EF..... Duration of certificate........................................................................ 30

41EG..... Lapsing of applications..................................................................... 30

41EH..... Treating applications as having been refused.................................... 31

41EI...... Criminal offences for making a false statement................................. 32

41EIA... Civil penalty for making a false statement......................................... 33

Division 2—Conditions                                                                                              34

41EJ...... Automatic conditions on conformity assessment certificates............. 34

41EK..... Conditions imposed when conformity assessment certificates are issued 36

41EL..... Conditions imposed after issuing a conformity assessment certificate 36

Division 3—Suspension of conformity assessment certificates             38

41EM.... Suspension of conformity assessment certificates............................. 38

41EN..... Notice of proposed suspension......................................................... 38

41EO..... Duration of suspension..................................................................... 39

41EP..... Revocation of suspension................................................................. 39

41EQ..... Powers of revocation of conformity assessment certificates unaffected 40

Division 4—Revocation of conformity assessment certificates            41

41ER..... Automatic revocation of conformity assessment certificates............. 41

41ES..... Immediate revocation of conformity assessment certificates............. 41

41ET..... Revocation of conformity assessment certificates after notice of proposed revocation             42

41EU..... Limiting revocation of conformity assessment certificates to some medical devices of a particular kind  44

41EV..... Publication of revocation etc. of conformity assessment certificates. 44

41EW.... Date of effect of revocation etc. of conformity assessment certificates 45

Part 4‑4A—Australian conformity assessment bodies                                  46

41EWA. Conformity assessment body determinations.................................... 46

41EWB. Content of Australian conformity assessment body certificates........ 49

41EWC. Duration of Australian conformity assessment body certificates....... 49

41EWD. Record‑keeping................................................................................. 50

Part 4‑5—Including medical devices in the Register                                      52

41F........ What this Part is about...................................................................... 52

Division 1—Including medical devices in the Register                             53

41FA..... What this Division is about............................................................... 53

Subdivision A—Applications                                                                                 53

41FC..... Making an application....................................................................... 53

41FD..... Matters to be certified........................................................................ 53

41FDA.. Basis of certification of conformity assessment procedures.............. 56

41FDB.. Preliminary assessment of applications............................................. 56

41FE..... Criminal offences for making a false statement................................. 58

41FEA.. Civil penalty for making a false statement......................................... 60

Subdivision B—Including kinds of medical devices in the Register            60

41FF..... Obligation to include kinds of medical devices in the Register.......... 60

41FG..... Notification of unsuccessful applications.......................................... 61

Subdivision C—Auditing of applications                                                           61

41FH..... Selecting applications for auditing..................................................... 61

41FI...... Auditing of applications.................................................................... 62

41FIA... Certificates issued by Australian conformity assessment bodies....... 63

41FJ...... Procedure following audits............................................................... 63

41FK..... Lapsing of applications..................................................................... 64

Subdivision D—Miscellaneous                                                                              65

41FKA.. Medical devices (priority applicant) determinations.......................... 65

41FL..... Device number.................................................................................. 66

41FM.... Duration of inclusion in the Register................................................. 67

Division 2—Conditions                                                                                              68

41FN..... Conditions applying automatically.................................................... 68

41FO..... Conditions imposed when kinds of medical devices are included in the Register     71

41FP..... Conditions imposed after kinds of medical devices are included in the Register      71

Part 4‑6—Suspension and cancellation from the Register                          73

Division 1—Suspension from the Register                                                      73

Subdivision A—General power of suspension                                                  73

41G....... What this Part is about...................................................................... 73

41GA.... Suspension of kinds of medical devices from the Register............... 73

41GB.... Notice of proposed suspension must be given in certain cases......... 74

41GC.... Duration of suspension..................................................................... 74

41GD.... Revocation of suspension................................................................. 75

41GE..... Treating applications for revocation as having been refused............. 76

Subdivision B—Suspension as a result of suspension of conformity assessment document        77

41GF..... Suspension where conformity assessment certificate suspended...... 77

41GFA.. Suspension where other certificates or documents are suspended..... 77

41GG.... Duration of suspension..................................................................... 78

41GH.... Revocation of suspension................................................................. 78

Subdivision C—Effect of suspension                                                                   79

41GI...... Effect of suspension.......................................................................... 79

41GJ..... Powers of cancellation from Register unaffected.............................. 79

Division 2—Cancellation of entries from the Register                             80

41GK.... Automatic cancellation of entries of kinds of medical devices from the Register      80

41GL..... Immediate cancellation of entries of kinds of medical devices from the Register      81

41GLA.. Revocation of cancellation of entries upon request............................ 82

41GLB.. Revocation of cancellation of entries—payment of annual charge..... 82

41GM... Cancellation of entries of kinds of medical devices from the Register after section 41JA notice              83

41GN.... Cancellation of entries of kinds of medical devices from the Register after notice of proposed cancellation            84

41GO.... Limiting cancellation of entries from Register to some medical devices of a particular kind     86

41GP..... Publication of cancellation of entry from Register............................. 86

41GQ.... Date of effect of cancellation of entries from Register....................... 86

Part 4‑6A—Exempting medical devices to deal with emergencies         88

41GR.... What this Part is about...................................................................... 88

41GS..... Minister may make exemptions......................................................... 88

41GT..... Conditions of exemptions................................................................. 90

41GU.... Variation or revocation of exemption................................................ 91

41GV.... Informing persons of exemption etc.................................................. 91

41GW... Notification and tabling..................................................................... 92

41GY.... Disposal of unused medical devices.................................................. 93

Part 4‑7—Other exemptions from including medical devices in the Register       94

41H....... What this Part is about...................................................................... 94

41HA.... Devices exempted from inclusion in the Register.............................. 94

41HB.... Approvals for special and experimental uses.................................... 95

41HC.... Authorities for health practitioners.................................................... 98

41HD.... Approvals if substitutes for medical devices are unavailable or in short supply       100

Part 4‑8—Obtaining information                                                                             105

41J........ What this Part is about.................................................................... 105

Division 1—Information relating to compliance with requirements and other matters               106

41JA..... Secretary may require information or documents............................ 106

41JB...... Complying with the Secretary’s requirements................................. 109

41JBA... Civil penalty for giving false or misleading information in purported compliance with a notice               111

41JC...... Self‑incrimination............................................................................ 112

Division 2—Information relating to medical devices covered by exemptions    113

41JCA... Secretary may require information etc. about medical devices exempt under Part 4‑6A           113

41JD..... Secretary may require information etc. about devices exempted under section 41HA from inclusion in the Register........................................................................................................ 113

41JE...... Secretary may require information relating to approvals under section 41HB          115

41JF...... Secretary may require information relating to health practitioner authorisations       116

41JFA... Secretary may require information relating to approvals under section 41HD          117

41JG..... Criminal offences for failing to give information or documents sought under this Division    118

41JH..... False or misleading information...................................................... 118

41JI....... False or misleading documents....................................................... 119

41JJ....... Self‑incrimination............................................................................ 120

Part 4‑9—Public notification, and recall, of medical devices                  122

41K....... What this Part is about.................................................................... 122

41KA.... Public notification, and recall, of medical devices........................... 122

41KB..... Publication of requirements............................................................. 126

41KC..... Criminal offences for failing to comply with requirements relating to a kind of medical device               126

41KCA.. Civil penalty for failing to comply with requirements relating to a kind of medical device       127

41KD.... Powers of suspension and cancellation unaffected.......................... 127

41KE..... Saving of other laws....................................................................... 127

Part 4‑10—Assessment fees                                                                                          128

41L........ What this Part is about.................................................................... 128

41LA..... Assessment fees.............................................................................. 128

41LB..... When assessment fee due for payment............................................ 129

41LC..... Payment of assessment fee by instalments...................................... 129

41LD..... Recovery of assessment fee............................................................ 129

41LE..... Reduction of conformity assessment fee where decision not made within prescribed period   130

Part 4‑11—Offences and civil penalty provisions relating to medical devices       131

41M...... What this Part is about.................................................................... 131

Division 1—Non‑compliance with essential principles                            132

41MA... Criminal offences for importing, supplying or exporting a medical device that does not comply with essential principles........................................................................................................ 132

41MAA Civil penalties for importing, supplying or exporting a medical device that does not comply with essential principles........................................................................................................ 136

41MB.... Exceptions....................................................................................... 137

41MC.... Criminal offences relating to breaching a condition of a consent..... 138

41MCA. Civil penalty relating to breaching a condition of a consent............. 139

41MD... Treating medical devices as prohibited imports or exports.............. 139

Division 2—Failure to apply conformity assessment procedures     140

41ME.... Criminal offences for failing to apply conformity assessment procedures—manufacturers     140

41MEA. Civil penalties for failing to apply conformity assessment procedures—manufacturers           143

41MF.... Criminal offences for failing to apply conformity assessment procedures—sponsors             143

41MG... Exceptions....................................................................................... 146

41MH... Criminal offence for making false statements in declarations.......... 146

41MHA Civil penalty for making false statements in declarations................ 147

Division 3—Medical devices not included in the Register and related matters 148

41MI..... Criminal offences for importing, exporting, supplying or manufacturing a medical device not included in the Register........................................................................................................ 148

41MIA.. Notice required to adduce evidence in support of exception under subsection 41MI(7)           151

41MIB.. Civil penalty for importing, exporting, supplying or manufacturing a medical device not included in the Register  153

41MJ..... Treating medical devices as prohibited imports or exports.............. 153

41MK.... Wholesale supply of medical devices not included in the Register.. 154

41ML.... False advertising about medical devices.......................................... 155

41MLA. Civil penalty for making misrepresentations about medical devices 156

41MLB. Civil penalty for false advertising about medical devices................ 156

41MN... Criminal offences relating to breaches of conditions....................... 157

41MNA Civil penalties for breaching conditions.......................................... 160

Division 3A—Offences and civil penalties related to exemptions under Part 4‑6A        161

41MNB. Criminal offences for breaching a condition of an exemption......... 161

41MNC. Civil penalty for breaching a condition of an exemption................. 162

41MND Civil penalty for making misrepresentations about medical devices 162

Division 4—Other offences and civil penalty provisions                       164

41MO... Criminal offences for misusing medical devices exempted for special or experimental uses    164

41MP.... Criminal offence for failing to notify adverse events etc................. 168

41MPA. Civil penalty for failing to notify adverse events etc........................ 169

41MPB. Relief from liability for contraventions for failing to notify adverse events etc.        171

41MQ... Notification of adverse events etc. where application withdrawn or lapses              172

41MR.... Civil penalties for failing to notify adverse effects etc. where application withdrawn or lapses                173

Chapter 5—Advertising, counterfeit therapeutic goods and product tampering          174

Part 5‑1—Advertising and generic information                                              174

Division 1—Preliminary                                                                                          174

42AA.... This Part not to apply to advertisements directed at health professionals etc.           174

42AB.... This Part not to apply to advertisements for goods not for human use 175

42AC.... This Part not to apply to advertisements for exported goods........... 175

42B....... Definitions...................................................................................... 175

42BAA. Therapeutic Goods Advertising Code............................................. 176

Division 3—General provisions about advertising therapeutic goods 177

42DA.... Simplified outline of this Division.................................................. 177

42DB.... Definitions...................................................................................... 177

42DD.... Restricted representations................................................................ 177

42DE..... Applications for approval of use of restricted representation.......... 178

42DF..... Approval of use of restricted representation.................................... 178

42DG.... Notice of approval or refusal........................................................... 179

42DH.... Variation of conditions of approval................................................. 179

42DI...... Withdrawal of approval................................................................... 179

42DJ..... Prohibited and required representations.......................................... 180

42DK.... Permitted use of restricted or prohibited representations................. 181

Division 3A—Advertising offences and civil penalties                            182

42DKB.. Certain representations not to be advertised.................................... 182

42DL..... Advertising offences—general........................................................ 182

42DLA.. Advertising offences—contravening section 42DKB notice........... 185

42DLB.. Civil penalty relating to advertisements—general............................ 186

42DLC.. Civil penalty relating to advertisements—contravening section 42DKB notice        189

42DM... Offences—non‑compliance with the Therapeutic Goods Advertising Code            189

42DMA Civil penalty—non‑compliance with the Therapeutic Goods Advertising Code       191

Division 4—Generic information about ingredients or components of therapeutic goods          193

42DN.... Application of Division................................................................... 193

42DO.... Compliance with the Code.............................................................. 193

42DP..... Offences—dissemination of generic information............................ 193

42DQ.... Civil penalty for dissemination of generic information.................... 194

Division 5—Secretary may require information or documents         195

42DR.... Secretary may require information or documents............................ 195

42DS..... Criminal offences for failing to comply with a notice etc................ 196

42DT..... Civil penalty for giving false or misleading information or document in compliance with a notice          197

42DU.... Self‑incrimination............................................................................ 197

Division 6—Directions about advertisements or generic information 198

42DV.... Directions about advertisements or generic information.................. 198

42DW... Offences—contravening direction under section 42DV.................. 199

42DX.... Civil penalty for contravening direction under section 42DV......... 200

Division 7—Public warning notices                                                                   202

42DY.... Secretary may issue a public warning notice................................... 202

Part 5‑2—Counterfeit therapeutic goods                                                            203

42E........ Offence of dealing with counterfeit therapeutic goods.................... 203

42EA..... Civil penalty relating to dealing with counterfeit therapeutic goods. 204

42EB..... Relief from liability for certain contraventions relating to dealing with counterfeit therapeutic goods      204

42F........ Customs treatment of counterfeit therapeutic goods........................ 205

Part 5‑3—Product tampering                                                                                     207

42T........ Notifying of actual or potential tampering....................................... 207

42U....... Meaning of actual or potential tampering etc................................. 208

42V....... Recall of therapeutic goods because of actual or potential tampering 209

42VA.... Civil penalty relating to the recall of therapeutic goods because of actual or potential tampering              211

42VB.... Relief from liability for contraventions relating to the recall of therapeutic goods because of actual or potential tampering........................................................................................................ 211

42W...... Supply etc. of therapeutic goods that are subject to recall requirements 212

42X....... Saving of other laws....................................................................... 213

Chapter 5A—Enforcement                                                                              214

Part 5A‑1—Civil penalties                                                                                            214

Division 1—Obtaining an order for a civil penalty                                  214

42Y....... Federal Court may order person to pay pecuniary penalty for contravening civil penalty provision         214

42YA.... What is a civil penalty provision?.................................................... 215

42YC.... Persons involved in contravening civil penalty provision............... 215

42YCA. Continuing contraventions of civil penalty provisions.................... 216

42YD.... Recovery of a pecuniary penalty..................................................... 216

42YE..... Gathering information for application for pecuniary penalty........... 216

Division 2—Civil penalty proceedings and criminal proceedings     218

42YF..... Civil proceedings after criminal proceedings................................... 218

42YG.... Criminal proceedings during civil proceedings............................... 218

42YH.... Criminal proceedings after civil proceedings................................... 218

42YI...... Evidence given in proceedings for civil penalty not admissible in criminal proceedings          218

Part 5A‑2—Infringement notices                                                                             220

42YJ..... Simplified outline of this Part.......................................................... 220

42YK.... When an infringement notice may be given..................................... 220

42YKA. Matters to be included in an infringement notice............................. 221

42YKB.. Extension of time to pay amount..................................................... 223

42YKC.. Withdrawal of an infringement notice............................................. 224

42YKD. Effect of payment of amount........................................................... 225

42YKE.. Effect of this Part............................................................................ 226

Part 5A‑3—Enforceable undertakings                                                                 227

42YL..... Enforcement of undertakings.......................................................... 227

Part 5A‑4—Injunctions                                                                                                  228

42YM... Simplified outline of this Part.......................................................... 228

42YN.... Grant of injunctions........................................................................ 228

42YO.... Interim injunctions.......................................................................... 229

42YP..... Discharging or varying injunctions................................................. 229

42YQ.... Certain limits on granting injunctions not to apply.......................... 229

42YR.... Other powers of court unaffected.................................................... 230

Chapter 6—Administration                                                                            231

Part 6‑1—Payment of charges                                                                                   231

43.......... By whom charges payable.............................................................. 231

44.......... Time for payment of charges........................................................... 231

44A....... Exemptions from liability to pay charges........................................ 232

44B....... Recovery of unpaid charges............................................................ 234

45.......... Therapeutic Goods Administration Account................................... 235

Part 6‑2—Entry, searches and warrants                                                             237

45A....... Definitions...................................................................................... 237

46.......... Searches to monitor compliance with Act or regulations................. 238

46A....... Searches of certain premises to monitor compliance with Act......... 238

46B....... Searches and seizures on public health grounds.............................. 240

47.......... Searches and seizures related to offences and civil penalty provisions 241

48.......... General powers of authorised persons in relation to premises........ 242

48A....... Details of warrant to be given to occupier etc.................................. 243

48AA.... Completing execution of warrant under section 50 after temporary cessation          244

48B....... Announcement before entry............................................................ 245

48BA.... Use of electronic equipment at premises for monitoring compliance with Act or regulations   245

48C....... Use of electronic equipment at premises relating to offences and civil penalty provisions       247

48D....... Compensation for damage to electronic equipment......................... 249

48E........ Copies of seized things to be provided............................................ 249

48F........ Occupier entitled to be present during search.................................. 250

48FA..... Responsibility to provide facilities and assistance........................... 250

48G....... Receipts for things seized under warrant......................................... 251

48H....... Retention of seized things............................................................... 251

48J........ Magistrate may permit a thing to be retained................................... 252

49.......... Monitoring warrants....................................................................... 252

50.......... Offence and civil penalty provision related warrants....................... 253

51.......... Offence and civil penalty provision related warrants by telephone.. 254

51A....... Inspections for purposes of Mutual Recognition Convention......... 256

51B....... Offences relating to warrants.......................................................... 256

52.......... Identity cards................................................................................... 257

Part 6‑3—Scheduling of substances                                                                        258

52AA.... Overview........................................................................................ 258

52A....... Definitions...................................................................................... 258

52B....... Advisory Committee on Medicines Scheduling.............................. 259

52C....... Advisory Committee on Chemicals Scheduling.............................. 260

52CA.... Joint meetings................................................................................. 261

52D....... Poisons Standard............................................................................ 261

52E........ Secretary to take certain matters into account in exercising powers. 262

52EAA.. Application for amendment of the Poisons Standard...................... 263

52F........ Incorporation of current Poisons Standard...................................... 264

Chapter 7—Miscellaneous                                                                                265

52G....... Exemptions, approvals and authorities to be consistent with prohibitions under Chapter 2A   265

53.......... Retention of material on withdrawal of application......................... 266

53A....... Alternative verdicts for various offences......................................... 266

54.......... Offences and forfeiture................................................................... 269

54AA.... Offences for contravening conditions or requirements imposed under the regulations             269

54AB.... Criminal offence for damaging etc. documents............................... 270

54AC.... Civil penalty for damaging etc. documents...................................... 271

54A....... Time for bringing prosecutions....................................................... 271

54B....... Personal liability of an executive officer of a body corporate—general 271

54BA.... Personal liability of an executive officer of a body corporate—offences covered     272

54C....... Establishing whether an executive officer took reasonable steps to prevent the commission of an offence or the contravention of a civil penalty provision........................................ 275

55.......... Conduct by directors, employees and agents................................... 276

56.......... Judicial notice.................................................................................. 277

56A....... Certificates to provide evidence of certain matters........................... 277

57.......... Delegation....................................................................................... 281

58.......... Export certifications........................................................................ 283

59.......... Fees................................................................................................. 284

60.......... Review of decisions........................................................................ 284

60A....... New information on review—discretion to remit............................ 289

61.......... Release of information.................................................................... 293

61A....... Immunity from civil actions............................................................ 299

62.......... Protection from criminal responsibility........................................... 300

63.......... Regulations..................................................................................... 300

Chapter 8—Repeal and transitional provisions                        304

66.......... Transitional arrangements for goods required to be registered or listed 304

67.......... Transitional provision for therapeutic goods for export only.......... 306

68.......... Transitional arrangements for Part 3‑3............................................ 306

69.......... Continuation of standards and requirements................................... 307

Endnotes                                                                                                                                  308

Endnote 1—About the endnotes                                                                          308

Endnote 2—Abbreviation key                                                                              310

Endnote 3—Legislation history                                                                           311

Endnote 4—Amendment history                                                                         323


Chapter 4Medical devices

Part 4‑1Introduction

Division 1Overview of this Chapter

41B  General

                   The purpose of this Chapter is to ensure the safety and satisfactory performance of medical devices. It does this by:

                     (a)  setting out particular requirements for medical devices; and

                     (b)  establishing administrative processes principally aimed at ensuring those requirements are met; and

                     (c)  providing for enforcement through a series of offences and civil penalty provisions.

41BA  Requirements for medical devices (Parts 4‑2 and 4‑3)

                   The requirements for medical devices are:

                     (a)  essential principles (that are about the safety and performance characteristics of medical devices); and

                     (b)  conformity assessment procedures (that are mainly about the application of quality management systems) or requirements comparable to conformity assessment procedures.

Note:          Medical device standards may be made under Division 2 of Part 4‑2, and conformity assessment standards may be made under Division 2 of Part 4‑3, but they are not requirements.

41BB  Administrative processes (Parts 4‑4 to 4‑10)

                   The administrative processes under this Chapter are:

                     (a)  issuing conformity assessment certificates for some manufacturers of medical devices; and

                    (aa)  making conformity assessment body determinations; and

                     (b)  including medical devices in the Register; and

                     (c)  suspending or cancelling entries of medical devices from the Register; and

                    (ca)  exempting medical devices from various provisions of this Chapter to deal with emergency situations; and

                     (d)  exempting medical devices from the requirement to be included in the Register; and

                     (e)  obtaining information about medical devices; and

                      (f)  requiring public notification of problems with medical devices, and recall of such devices.

Note:          Part 4‑10 provides for assessment fees to be payable in some circumstances.

41BC  Enforcement (Part 4‑11)

                   Part 4‑11 contains offences and civil penalty provisions that are aimed at ensuring that:

                     (a)  the requirements for medical devices are complied with; and

                     (b)  the administrative processes under this Chapter (particularly the inclusion of medical devices in the Register) are followed.

Note:          There are some offences and civil penalty provisions in Parts 4‑4 to 4‑9. They generally relate to matters ancillary to administrative processes in those Parts (e.g. false or misleading statements in applications).

Division 2Interpretation

41BD  What is a medical device

             (1)  A medical device is:

                     (a)  any instrument, apparatus, appliance, software, implant, reagent, material or other article (whether used alone or in combination, and including the software necessary for its proper application) intended, by the person under whose name it is or is to be supplied, to be used for human beings for the purpose of one or more of the following:

                              (i)  diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease;

                             (ii)  diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability;

                            (iii)  investigation, replacement or modification of the anatomy or of a physiological or pathological process or state;

                            (iv)  control or support of conception;

                             (v)  in vitro examination of a specimen derived from the human body for a specific medical purpose;

                            and that does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but that may be assisted in its function by such means; or

                    (aa)  any instrument, apparatus, appliance, software, implant, reagent, material or other article specified under subsection (2A); or

                   (ab)  any instrument, apparatus, appliance, software, implant, reagent, material or other article that is included in a class of instruments, apparatus, appliances, software, implants, reagents, materials or other articles specified under subsection (2B); or

                     (b)  an accessory to an instrument, apparatus, appliance, software, implant, reagent, material or other article covered by paragraph (a), (aa) or (ab); or

                     (c)  a system or procedure pack.

Note:          Declarations under subsection (3) exclude articles from the scope of this definition. Declarations under section 7 can also have this effect: see subsection 7(4).

             (2)  For the purposes of paragraph (1)(a), the purpose for which an instrument, apparatus, appliance, software, implant, reagent, material or other article (the main equipment) is to be used is to be ascertained from the information supplied, by the person under whose name the main equipment is or is to be supplied, on or in any one or more of the following:

                     (a)  the labelling on the main equipment;

                     (b)  the instructions for using the main equipment;

                     (c)  any advertising material relating to the main equipment;

                     (d)  technical documentation describing the mechanism of action of the main equipment.

          (2A)  The Secretary may, by notice published in the Gazette or on the Department’s website, specify a particular instrument, apparatus, appliance, software, implant, reagent, material or other article for the purposes of paragraph (1)(aa). The notice is not a legislative instrument.

          (2B)  The Secretary may, by legislative instrument, specify a particular class of instruments, apparatus, appliances, software, implants, reagents, materials or other articles for the purposes of paragraph (1)(ab).

             (3)  The Secretary may, by order published in the Gazette or on the Department’s website, declare that a particular instrument, apparatus, appliance, software, implant, reagent, material or other article, or that a particular class of instruments, apparatus, appliances, software, implants, reagents, materials or other articles, are not, for the purposes of this Act, medical devices.

Note:          A declaration under this section does not stop articles from being therapeutic goods.

             (4)  A declaration under this section takes effect on the day on which the declaration is published in the Gazette or on the Department’s website or on such later day as is specified in the order.

41BE  Kinds of medical devices

General

             (1)  For the purposes of this Chapter, a medical device is taken to be of the same kind as another medical device if they:

                     (a)  have the same sponsor; and

                     (b)  have the same manufacturer; and

                     (c)  have the same device nomenclature system code (see subsection (3)); and

                     (d)  have the same medical device classification; and

                     (e)  are the same in relation to such other characteristics as the regulations prescribe, either generally or in relation to medical devices of the kind in question.

Unique medical devices

             (2)  If a medical device is not of the same kind as any other medical device:

                     (a)  this Chapter applies in relation to the device as if it were a kind of medical device; and

                     (b)  references in this Chapter to delivering a reasonable number of samples of the kind of device are taken to be references to delivering the device.

Device nomenclature codes

             (3)  The Minister may, by legislative instrument, determine device nomenclature codes for medical devices.

41BEA  Excluded purposes

                   The Secretary may, by legislative instrument, specify purposes for the purposes of paragraph 41FD(ia) and subsection 41FF(1A).

41BF  System or procedure packs

                   Two or more goods (including at least one medical device) are a system or procedure pack if:

                     (a)  all of the goods are to be interconnected or combined for use in a medical or surgical procedure; or

                     (b)  all of the goods are packaged together for use in a medical or surgical procedure.

41BG  Manufacturers of medical devices

             (1)  The manufacturer of a medical device is the person who is responsible for the design, production, packaging and labelling of the device before it is supplied under the person’s name, whether or not it is the person, or another person acting on the person’s behalf, who carries out those operations.

             (2)  If subsection (1) does not apply to a medical device, the manufacturer of the device is the person who, with a view to supplying the device under the person’s name, does one or more of the following using ready‑made products:

                     (a)  assembles the device;

                     (b)  packages the device;

                     (c)  processes the device;

                     (d)  fully refurbishes the device;

                     (e)  labels the device;

                      (f)  assigns to the device its purpose by means of information supplied, by the person, on or in any one or more of the following:

                              (i)  the labelling on the device;

                             (ii)  the instructions for using the device;

                            (iii)  any advertising material relating to the device;

                            (iv)  technical documentation describing the mechanism of action of the device.

             (3)  However, a person is not the manufacturer of a medical device if:

                     (a)  the person assembles or adapts the device for an individual patient; and

                     (b)  the device has already been supplied by another person; and

                     (c)  the assembly or adaptation does not change the purpose intended for the device by means of information supplied by that other person, on or in any one or more of the following:

                              (i)  the labelling on the device;

                             (ii)  the instructions for using the device;

                            (iii)  any advertising material relating to the device;

                            (iv)  technical documentation describing the mechanism of action of the device.

             (4)  A person is not the manufacturer of a medical device if the person is included in a class of persons prescribed by the regulations for the purposes of this subsection.

41BH  Meaning of compliance with essential principles

             (1)  A medical device complies, for the purposes of this Chapter (including Part 4‑11), with the essential principles if and only if it does not contravene any of the essential principles.

             (2)  However, a medical device is also taken, for the purposes of this Chapter (other than Part 4‑11), to comply with the essential principles if:

                     (a)  the medical device complies with one or more medical device standards that apply to it; and

                     (b)  the medical device contravenes the essential principles only in respect of a part or parts of the essential principles to which that medical device standard, or one or more of those medical device standards, relate.

             (3)  For the purposes of this section, a medical device standard relates to a part or parts of the essential principles only if the standard specifies that part or parts.

41BI  Meaning of non‑application of conformity assessment procedures

             (1)  A conformity assessment procedure is taken, for the purposes of this Chapter, not to have been applied to a medical device if:

                     (a)  there has been a contravention of the conformity assessment procedures; and

                     (b)  the contravention relates, wholly or partly, to that device or its manufacture.

             (2)  However, for the purposes of this Chapter (other than Part 4‑11), subsection (1) does not apply if:

                     (a)  the quality management system applied in the manufacture of the medical device complies with one or more conformity assessment standards that apply to it; and

                     (b)  the contravention is only in respect of a part or parts of the conformity assessment procedures to which that conformity assessment standard, or one or more of those conformity assessment standards, relate.

             (3)  For the purposes of this section, a conformity assessment standard relates to a part or parts of the conformity assessment procedures only if the standard specifies that part or parts.

41BIA  Meaning of non‑application of overseas requirements comparable to conformity assessment procedures

             (1)  A requirement that is comparable to a conformity assessment procedure is taken, for the purposes of this Chapter, not to have been applied to a medical device by the manufacturer of the device if:

                     (a)  there has been a contravention of the requirement; and

                     (b)  the contravention relates, wholly or partly, to that device or its manufacture.

             (2)  However, for the purposes of this Chapter (other than Part 4‑11), subsection (1) does not apply if:

                     (a)  the quality management system applied in the manufacture of the medical device complies with one or more conformity assessment standards that apply to it; and

                     (b)  the contravention is only in respect of a part or parts of the requirement to which that conformity assessment standard, or one or more of those conformity assessment standards, relate.

41BIB  Overseas regulators

             (1)  An overseas regulator is a body determined in an instrument under subsection (2).

             (2)  The Secretary may, by notifiable instrument, determine a body for the purposes of subsection (1). The Secretary must be satisfied that the body:

                     (a)  is established outside Australia; and

                     (b)  is empowered to issue certificates or other documents to the effect that the body is satisfied that requirements, comparable to the conformity assessment procedures, have been applied to medical devices by the manufacturers of the devices.

             (3)  Without limiting subsection (2), the Secretary may determine a body by reference to a designation, recognition, approval or authorisation (however described) of the body:

                     (a)  by one or more countries; or

                     (b)  by another body.

Note:          For specification by class, see subsection 13(3) of the Legislation Act 2003.

Division 3Application provisions

41BJA  Application of this Chapter to a biological

             (1)  Subject to this section, this Chapter does not apply to a biological on and after the commencement of this section.

Biologicals currently included in the Register

             (2)  If, immediately before the commencement of this section, therapeutic goods that are a biological were included in the Register under this Chapter, this Chapter continues to apply to the biological on and after that commencement until the time the biological is included in the Register under Part 3‑2A.

Note:          Section 32DN deals with including the biological under Part 3‑2A.

Pending applications

             (3)  If:

                     (a)  before the commencement of this section, an application was made under this Chapter for the inclusion in the Register of therapeutic goods that are a biological; and

                     (b)  immediately before that commencement, the application was not finally determined; and

                     (c)  the application had not been withdrawn before that commencement;

this Chapter continues to apply to the biological on and after that commencement until the earliest of the following:

                     (d)  the time the biological is included in the Register under Part 3‑2A;

                     (e)  if the application is unsuccessful when it is finally determined—the time the application is finally determined;

                      (f)  the time the application is withdrawn;

                     (g)  the time the application lapses.

Note:          Section 32DN deals with including the biological under Part 3‑2A.

             (4)  For the purposes of this section, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.

Transitional

             (5)  This Chapter applies to a biological on and after the commencement of this section in relation to things done, or omitted to be done, in relation to the biological before the commencement of this section.

             (6)  If this Chapter continues to apply to a biological during a period described in subsection (2) or (3), then this Chapter also applies to the biological after the end of that period in relation to things done, or omitted to be done, in relation to the biological during that period.

41BK  Application of the Criminal Code

                   Chapter 2 of the Criminal Code applies to all offences against this Chapter.

Note:          Chapter 2 of the Criminal Code sets out the general principles of criminal responsibility.

Part 4‑2Essential principles and medical device standards

  

41C  What this Part is about

The essential principles set out the requirements relating to the safety and performance characteristics of medical devices. Compliance with applicable medical device standards is not required, but it is one way to establish compliance with essential principles. The regulations may make provision for and in relation to the Secretary causing a database of unique device identifiers of medical devices to be established and maintained.

Note:          Dealing in medical devices that do not comply with the essential principles may be an offence or may contravene a civil penalty provision: see Division 1 of Part 4‑11.

Division 1Essential principles

41CA  Essential principles

             (1)  The regulations may set out requirements for medical devices.

             (2)  These requirements are to be known as the essential principles.

             (3)  Regulations made for the purposes of subsection (1) may include requirements in relation to the inclusion in the database referred to in section 41CE of the following:

                     (a)  unique device identifiers of medical devices;

                     (b)  information relating to those unique device identifiers, those medical devices or the import, export, manufacture or supply of those medical devices.

             (4)  Subsection (3) has effect subject to subsection 41CE(2).

             (5)  Subsection (3) does not limit subsection (1).

Division 2Medical device standards

41CB  Medical device standards

             (1)  The Minister may, by legislative instrument, make an order determining that:

                     (a)  matters specified in the order constitute a medical device standard for kinds of medical devices identified in the order; and

                     (b)  medical devices of those kinds that comply with the standard are to be treated as complying with those parts of the essential principles specified in the standard.

Note:          Section 12 of the Legislation Act 2003 deals with when a legislative instrument commences.

             (2)  The Minister may, by legislative instrument, vary or revoke an order made under subsection (1).

             (3)  Despite subsection 14(2) of the Legislation Act 2003, an order under subsection (1) of this section, or a variation of such an order, may make provision in relation to a matter by applying, adopting or incorporating, with or without modification, any matter contained in an instrument or other writing as in force or existing from time to time.

41CC  Content of medical device standards

             (1)  Without limiting the scope of section 41CB, an order establishing a medical device standard for kinds of medical devices may be specified by reference to:

                     (a)  the safety or performance characteristics of the devices; or

                     (b)  a monograph in the British Pharmacopoeia, the European Pharmacopoeia or the United States Pharmacopeia‑National Formulary; or

                     (c)  a monograph in a publication approved by the Minister for the purposes of this subsection; or

                     (d)  such a monograph as modified in a manner specified in the order; or

                     (e)  a standard published by a standards organisation; or

                      (f)  such other matters as the Minister thinks fit.

             (2)  For the purposes of paragraph (1)(e), these are standards organisations:

                     (a)  Standards Australia;

                     (b)  the International Organisation for Standardization;

                     (c)  the International Electrotechnical Commission;

                     (d)  the European Committee for Standardization;

                     (e)  the European Committee for Electrotechnical Standardization;

                      (f)  any other organisation declared by the Minister by notice published in the Gazette or on the Department’s website.

41CD  Inconsistencies between medical device standards

             (1)  A medical device standard that:

                     (a)  applies to a kind of medical device; and

                     (b)  is inconsistent with another medical device standard that applies only to some of the devices of that kind;

is, to the extent of the inconsistency, of no effect in relation to the devices referred to in paragraph (b).

             (2)  A medical device standard that applies to a kind of medical device that consists of a combination of component parts takes precedence over any medical device standard that applies to the component parts.

Division 3Database of unique device identifiers of medical devices

41CE  Database of unique device identifiers of medical devices

             (1)  The regulations may make provision for and in relation to the Secretary causing a database to be established and maintained, to be known as:

                     (a)  the Australian Unique Device Identification Database; or

                     (b)  if another name is prescribed by the regulations—that other name.

Note:          The essential principles may include requirements in relation to the inclusion in the database of unique device identifiers of medical devices and related information: see subsection 41CA(3).

Personal information

             (2)  The regulations must provide that the database must not include personal information, unless the personal information:

                     (a)  is the name of a person in relation to whom a kind of medical device is included in the Register; or

                     (b)  is about an authorised representative of the manufacturer of a kind of medical device; or

                     (c)  is about an authorised representative of a person in relation to whom a kind of medical device is included in the Register.

Removal of information

             (3)  The regulations may provide for the removal of information from the database.

Corrections to information

             (4)  The regulations may provide for corrections to information in the database.

Making the database available

             (5)  The regulations may provide for the whole or a part of the database to be made:

                     (a)  available to specified persons, authorities or bodies; or

                     (b)  publicly available.

             (6)  However, the regulations must provide that personal information covered by paragraph (2)(b) or (c) must not be made publicly available.

No limit on subsection (1)

             (7)  Subsections (2) to (6) do not limit subsection (1).

Database not a legislative instrument

             (8)  The database is not a legislative instrument.

Part 4‑3Conformity assessment procedures

  

41D  What this Part is about

The conformity assessment procedures set out the requirements relating to the application of quality management systems for medical devices, and other requirements imposed on manufacturers.

Compliance with applicable conformity assessment standards is not required, but it is one way to establish that one or more parts of the conformity assessment procedures have been applied to medical devices.

Note 1:       Dealing in medical devices that have not had the conformity assessment procedures applied may be an offence or may contravene a civil penalty provision: see Division 2 of Part 4‑11.

Note 2:       See section 41BI on applying the conformity assessment procedures.

Division 1Conformity assessment procedures

41DA  Conformity assessment procedures

             (1)  The regulations may set out requirements relating to the obligations of manufacturers of medical devices.

             (2)  These requirements are to be known as the conformity assessment procedures.

             (3)  The conformity assessment procedures, or any part of the conformity assessment procedures, may:

                     (a)  be limited in their application to one or more medical device classifications; or

                     (b)  apply differently to different medical device classifications, different kinds of medical devices or different manufacturers.

             (4)  Without limiting subsection (1), the regulations may relate to all or any of the following:

                     (a)  application of quality management systems for the manufacture of medical devices;

                     (b)  certification of compliance with the essential principles, or the quality management systems for the manufacture of medical devices;

                     (c)  notification of, and assessment of, changes to a manufacturer’s product range, product design or quality management systems;

                     (d)  declarations to be made by manufacturers of medical devices that conformity assessment procedures have been applied to the devices;

                     (e)  marks to be affixed to medical devices indicating the application of the conformity assessment procedures to the devices;

                      (f)  monitoring and inspecting the design of medical devices or the manufacturing processes for medical devices;

                     (g)  monitoring the performance of medical devices;

                     (h)  corrective action required in relation to the design, manufacture, packaging, labelling and supply of medical devices;

                      (i)  keeping records of the manufacture of medical devices, the design of medical devices or the manufacturing processes for medical devices.

41DB  Medical device classifications

                   The regulations may specify:

                     (a)  classifications, to be known as medical device classifications, applying to medical devices or kinds of medical devices; and

                     (b)  matters in relation to the classification of medical devices or kinds of medical devices.

Division 2Conformity assessment standards

41DC  Conformity assessment standards

             (1)  The Minister may, by legislative instrument, make an order determining that:

                     (a)  matters specified in the order constitute a conformity assessment standard for quality management systems identified in the order; and

                     (b)  a quality management system that complies with the standard is to be treated as having had applied to it those parts of the conformity assessment procedures specified in the standard.

Note:          Section 12 of the Legislation Act 2003 deals with when a legislative instrument commences.

             (2)  A conformity assessment standard may be limited to particular kinds of medical devices.

             (3)  The Minister may, by legislative instrument, vary or revoke an order made under subsection (1).

             (4)  Despite subsection 14(2) of the Legislation Act 2003, an order under subsection (1) of this section, or a variation of such an order, may make provision in relation to a matter by applying, adopting or incorporating, with or without modification, any matter contained in an instrument or other writing as in force or existing from time to time.

41DD  Content of conformity assessment standards

             (1)  Without limiting the scope of section 41DC, an order establishing a conformity assessment standard for a kind of medical device may be specified by reference to:

                     (a)  procedures to be carried out under the quality management systems for the design, manufacture and final inspection of the devices; or

                     (b)  a standard published by a standards organisation; or

                     (c)  such other matters as the Minister thinks fit.

             (2)  For the purposes of paragraph (1)(b), these are standards organisations:

                     (a)  Standards Australia;

                     (b)  the International Organisation for Standardization;

                     (c)  the European Committee for Standardization;

                     (d)  any other organisation declared by the Minister by notice published in the Gazette or on the Department’s website.

41DE  Inconsistencies between conformity assessment standards

                   A conformity assessment standard that:

                     (a)  identifies quality management systems to which it applies; and

                     (b)  is inconsistent with another conformity assessment standard that applies only to particular kinds of medical devices;

is, to the extent of the inconsistency, of no effect in relation to the devices referred to in paragraph (b).

Part 4‑4Conformity assessment certificates

  

41E  What this Part is about

The Secretary can issue a conformity assessment certificate (which may be limited to some medical devices) in respect of a manufacturer of medical devices, signifying one or more of these:

               (a)     that relevant quality management systems have been applied to the device;

              (b)     the essential principles for the device have been complied with;

               (c)     other certification requirements of the conformity assessment procedures have been met.

Note:          A conformity assessment certificate may be required for an application to include a kind of medical device in the Register to pass preliminary assessment: see paragraph 41FDB(2)(e).

Division 1Issuing conformity assessment certificates

41EA  When conformity assessment certificates are required

                   The regulations may prescribe:

                     (a)  kinds of manufacturers in respect of whom a conformity assessment certificate must be issued before valid applications can be made for kinds of medical devices, manufactured by those manufacturers, to be included in the Register; or

                     (b)  kinds of medical devices in respect of which a conformity assessment certificate must be issued before valid applications can be made for those kinds of medical devices to be included in the Register.

Note:          The regulations may prescribe different levels of fees for different kinds of manufacturers and medical devices: see subsection 41LA(2).

41EB  Applications

             (1)  An application for a conformity assessment certificate must:

                     (a)  be made in accordance with a form approved, in writing, by the Secretary or in such other manner as is approved, in writing, by the Secretary; and

                     (b)  be delivered to an office of the Department specified by the Secretary.

Note:          A conformity assessment fee is payable under section 41LA for consideration of the application.

             (2)  An application is not effective if:

                     (a)  the prescribed application fee has not been paid; or

                     (b)  the application contains information that is false or misleading in a material particular.

Note:          A person might also commit an offence, or contravene a civil penalty provision, if the person makes a statement in an application that is false or misleading in a material particular: see sections 41EI and 41EIA.

             (3)  An approval of a form may require or permit an application or information to be given in accordance with specified software requirements:

                     (a)  on a specified kind of data processing device; or

                     (b)  by way of a specified kind of electronic transmission.

             (4)  The Secretary may, by written notice given to an applicant for a conformity assessment certificate, require the applicant to allow an authorised person, at any reasonable time specified in the notice, to inspect:

                     (a)  the premises (including premises outside Australia) and equipment, processes and facilities that are being or will be used to manufacture medical devices of the kind in question; and

                     (b)  any other kinds of medical devices on those premises.

41EC  Considering applications

             (1)  If the application is made in accordance with section 41EB, the Secretary must decide whether to issue the conformity assessment certificate.

             (2)  In deciding whether to issue the certificate, the Secretary must consider some or all aspects of whether the conformity assessment procedures relating to one or more of the following have been applied to the medical device:

                     (a)  the application of quality management systems for the manufacture of medical devices;

                     (b)  the certification of compliance with the essential principles;

                     (c)  any other requirement of the conformity assessment procedures specified in regulations made for the purposes of this subsection.

             (3)  In deciding whether to issue the certificate, the Secretary must also consider:

                     (a)  whether at least one of the following persons:

                              (i)  the applicant;

                             (ii)  a person (a manager) who makes, or participates in making, decisions that affect the whole, or a substantial part, of the applicant’s affairs;

                            (iii)  if the applicant is a body corporate—a major interest holder of the body corporate;

                            has, within the 10 years immediately before the application:

                            (iv)  been convicted of an offence against this Act or a corresponding State law; or

                             (v)  been convicted of an offence against a law of the Commonwealth or a law of a State or Territory involving fraud or dishonesty; or

                            (vi)  been ordered to pay a pecuniary penalty for the contravention of a civil penalty provision of this Act or a corresponding State law; or

                           (vii)  been ordered to pay a pecuniary penalty for the contravention of a civil penalty provision of a law of the Commonwealth or a law of a State or Territory involving fraud or dishonesty; or

                          (viii)  breached a condition of a conformity assessment document; or

                            (ix)  had a conformity assessment document suspended or revoked; or

                             (x)  been a manager, or a major interest holder, of a body corporate in respect of which subparagraph (iv), (v), (vi), (vii), (viii) or (ix) applies in that 10 year period, if the conduct resulting in that subparagraph applying occurred when the person was a manager or major interest holder of the body corporate; or

                     (b)  whether any other circumstances prescribed by the regulations for the purposes of this paragraph exist.

             (4)  A reference in paragraph (3)(a) to a person convicted of an offence includes a reference to a person in respect of whom an order has been made relating to the offence under:

                     (a)  section 19B of the Crimes Act 1914; or

                     (b)  a corresponding provision of a law of a State or Territory.

Note:          Section 19B of the Crimes Act 1914 empowers a court that has found a person to have committed an offence to take action without proceeding to record a conviction.

             (5)  Paragraph (3)(a) does not limit paragraph (3)(b).

             (6)  The Secretary may, by written notice given to the applicant, require the applicant:

                     (a)  to deliver to the office to which the application was made a reasonable number of samples of the kind of medical device to which the application relates within the period, of not less than 14 days after the day the notice is given, specified in the notice; and

                     (b)  to do so in a manner specified in the notice.

41ECA  Conformity assessment (priority applicant) determinations

             (1)  The regulations may make provision for and in relation to empowering the Secretary to make conformity assessment (priority applicant) determinations.

             (2)  A conformity assessment (priority applicant) determination is a determination that, for the purposes of this Act, a specified person is a priority applicant in relation to any section 41EB application that may be made by the person for a conformity assessment certificate in relation to medical devices of a kind specified in the determination.

             (3)  The regulations may make provision for and in relation to the following matters:

                     (a)  applications for conformity assessment (priority applicant) determinations;

                     (b)  the approval by the Secretary of a form for such an application;

                     (c)  information that must accompany such an application;

                     (d)  the application fee for such an application;

                     (e)  empowering the Secretary to give the applicant a written notice requiring the applicant to give to the Secretary specified information or documents in connection with the application within a specified period (which must be at least 10 working days after the notice is given to the applicant).

             (4)  The regulations may make provision for and in relation to the following matters:

                     (a)  empowering the Secretary to revoke a conformity assessment (priority applicant) determination;

                     (b)  the consequences of the revocation of a conformity assessment (priority applicant) determination.

             (5)  Subsections (3) and (4) do not limit subsection (1).

             (6)  The regulations may make provision for and in relation to the priority to be given by the Secretary to consideration of a section 41EB application where the applicant is a priority applicant.

             (7)  The regulations may provide that, if:

                     (a)  a person is a priority applicant in relation to a section 41EB application made by the person; and

                     (b)  a decision is made on the application;

a statement setting out the decision may be published on the Department’s website.

             (8)  The express references in this section to the Secretary do not, by implication, prevent the regulations from empowering the Secretary to delegate any or all of the Secretary’s functions or powers under regulations made for the purposes of this section.

             (9)  If a conformity assessment (priority applicant) determination is in force under the regulations, the determination may be published on the Department’s website.

           (10)  A conformity assessment (priority applicant) determination made under the regulations is not a legislative instrument.

           (11)  Subsection 33(3AB) of the Acts Interpretation Act 1901 does not apply to the specification of a person in a conformity assessment (priority applicant) determination.

Note:          Subsection 33(3AB) of the Acts Interpretation Act 1901 deals with specification by class.

41ED  Time for making decisions on applications

                   If the application relates to the issuing of a conformity assessment certificate in relation to which a period has been prescribed under paragraph 63(2)(dc), a decision on the application must be made within that period, unless the application lapses under section 41EG.

41EE  Procedure following making a decision whether to issue certificate

             (1)  After making a decision whether to issue a conformity assessment certificate, the Secretary must:

                     (a)  notify the applicant in writing of his or her decision within 20 working days; and

                     (b)  if the decision is not to issue the certificate—state in the notice the reasons for the decision; and

                     (c)  if the decision is to issue the certificate and all assessment fees that are due and payable for the application have been paid:

                              (i)  issue the certificate to the manufacturer in relation to whom the application was made; and

                             (ii)  give the applicant a copy of the certificate (if the applicant is not the manufacturer).

             (2)  A conformity assessment certificate must specify whether it covers:

                     (a)  all medical devices manufactured by the manufacturer; or

                     (b)  only specified medical devices manufactured by the manufacturer.

             (3)  A conformity assessment certificate must contain any other information prescribed by the regulations for the purposes of this subsection.

41EF  Duration of certificate

             (1)  The conformity assessment certificate commences on the day specified for the purpose in the certificate. The certificate must specify the period for which it is to be in force (which must be no longer than 5 years).

             (2)  A conformity assessment certificate has effect at all times:

                     (a)  unless the certificate is suspended under Division 3; or

                     (b)  until the end of the period specified in the certificate, or if the Secretary extends that period, until the end of that extended period; or

                     (c)  until the certificate is revoked under Division 4.

Extensions

             (3)  The Secretary may, in writing and on his or her own initiative, extend the period for which a conformity assessment certificate is in force.

             (4)  An extension must be no longer than 12 months.

             (5)  Only one extension may be given.

             (6)  The Secretary:

                     (a)  must give notice of an extension to the manufacturer in relation to whom the certificate was issued; and

                     (b)  may give notice of an extension to the applicant for the certificate (if the applicant is not the manufacturer).

41EG  Lapsing of applications

                   An application for a conformity assessment certificate lapses if:

                     (a)  the applicant does not deliver to the office to which the application was made such information (in a form approved in writing by the Secretary) as will allow the certificate to be issued; or

                     (b)  the applicant does not comply with a requirement by the Secretary under subsection 41EC(6) to deliver to the office to which the application was made a reasonable number of samples of the kind of medical device to which the application relates; or

                     (c)  the applicant fails to comply with a notice under section 41JA to give to the Secretary information within a further 10 working days from the day specified in the notice; or

                     (d)  information given to the Secretary by, or on behalf of, the applicant in connection with the application, including information given for the purpose of a notice under section 41JA, is false or misleading in a material particular; or

                     (e)  the applicant fails to allow an authorised person to carry out any inspection as required under subsection 41EB(4); or

                      (f)  for the whole or a part of the conformity assessment fee for the application that is due and payable in accordance with regulations made for the purposes of Part 4‑10—the applicant fails to pay that whole or part in accordance with those regulations.

41EH  Treating applications as having been refused

             (1)  The applicant for an application for a conformity assessment certificate may give the Secretary written notice that the applicant wishes to treat the application as having been refused if:

                     (a)  a period is prescribed under paragraph 63(2)(dc) for making a decision on the application; and

                     (b)  at the end of the period, the applicant has not been notified of a decision whether to issue the certificate.

             (2)  The notice may be given at any time before the applicant is notified of the decision.

             (3)  If a notice has been given, this Act (except for subsection 60(5)) has effect as if:

                     (a)  the Secretary had decided not to issue the certificate; and

                     (b)  the Minister had made a decision under subsection 60(3) confirming the decision of the Secretary; and

                     (c)  the Minister’s decision had been made on the day on which notice was given to the Secretary.

41EI  Criminal offences for making a false statement

             (1)  A person commits an offence if:

                     (a)  the person makes a statement (whether orally, in a document or in any other way); and

                     (b)  the statement is made in or in connection with an application for a conformity assessment certificate; and

                     (c)  the person knows that the statement is false or misleading in a material particular; and

                     (d)  either:

                              (i)  the use of the kind of medical device has resulted in, will result in, or is likely to result in, harm or injury to any person; or

                             (ii)  the use of the kind of medical device, if the kind of medical device were used, would result in, or would be likely to result in, harm or injury to any person.

Penalty:  Imprisonment for 5 years or 4,000 penalty units, or both.

Note 1:       A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A.

Note 2:       For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

             (4)  A person commits an offence if:

                     (a)  the person makes a statement (whether orally, in a document or in any other way); and

                     (b)  the statement is in or in connection with an application for a conformity assessment certificate; and

                     (c)  the person knows that the statement is false or misleading in a material particular.

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.

             (5)  A person commits an offence if:

                     (a)  the person makes a statement (whether orally, in a document or in any other way); and

                     (b)  the statement is in or in connection with an application for a conformity assessment certificate; and

                     (c)  the statement is false or misleading in a material particular.

Penalty:  100 penalty units.

             (6)  An offence against subsection (5) is an offence of strict liability.

41EIA  Civil penalty for making a false statement

                   A person contravenes this section if:

                     (a)  the person makes a statement (whether orally, in a document or in any other way); and

                     (b)  the statement is false or misleading in a material particular; and

                     (c)  the statement is in or in connection with an application for a conformity assessment certificate.

Maximum civil penalty:

                     (a)  for an individual—5,000 penalty units; and

                     (b)  for a body corporate—50,000 penalty units.

Division 2Conditions

Note:       Breaching conditions of the conformity assessment certificate may lead to suspension or revocation of the certificate (see Divisions 3 and 4), may be an offence (see subsections 41MN(5), (8) and (8A)), and may contravene a civil penalty provision (see subsection 41MNA(2)).

41EJ  Automatic conditions on conformity assessment certificates

Entry and inspection powers

             (1)  A conformity assessment certificate is subject to the conditions that the manufacturer in respect of whom the certificate is issued will:

                     (a)  allow an authorised person:

                              (i)  to enter, at any reasonable time, premises (including premises outside Australia) at which the person or any other person deals with medical devices of a kind covered by the certificate; and

                             (ii)  while on those premises, to inspect those premises and medical devices of any kind on those premises and to examine, take measurements of, conduct tests on, require tests to be conducted on or take samples of medical devices of any kind on those premises or any thing on those premises that relates to medical devices of any kind; and

                            (iii)  while on those premises, to make any still or moving image or any recording of those premises or any thing on those premises; and

                     (b)  if requested to do so by an authorised person:

                              (i)  produce to the person such documents relating to devices of a kind covered by the certificate, or to the manufacturer’s quality management system, as the person requires; and

                             (ii)  allow the person to copy the documents.

Review

             (2)  A conformity assessment certificate is subject to the condition that the manufacturer in respect of whom the certificate is issued will cooperate in any review by the Secretary of the certificate to determine whether the conformity assessment procedures relating to the following matters have been applied to the kinds of medical devices covered by the certificate:

                     (a)  the application of quality management systems for the manufacture of medical devices;

                     (b)  the certification of compliance with the essential principles;

                     (c)  any other requirement of the conformity assessment procedures specified in the regulations made for the purposes of subsection 41EC(2).

Notification of substantial changes

             (3)  A conformity assessment certificate is subject to the condition that the person in respect of whom the certificate is issued will notify the Secretary, in writing, of any plan for substantial changes to:

                     (a)  quality management systems; or

                     (b)  the product range covered by those systems; or

                     (c)  the product design of kinds of medical devices;

in respect of which the certificate is issued.

Fees

             (4)  A conformity assessment certificate is subject to the condition that the applicant for the certificate will pay a fee, prescribed in the regulations, for a review under subsection (2), when the fee becomes due and payable.

             (5)  The regulations may prescribe different levels of fees for different kinds of manufacturers and medical devices.

Conditions in regulations

          (5A)  A conformity assessment certificate is subject to any conditions prescribed by the regulations for the purposes of this subsection.

Conditions do not limit other conditions

             (6)  A condition imposed under this section is in addition to any conditions imposed under this Division.

41EK  Conditions imposed when conformity assessment certificates are issued

                   If the Secretary issues a conformity assessment certificate in respect of a manufacturer, the Secretary may, in writing, impose conditions on the certificate in respect of:

                     (a)  one or more kinds of medical devices covered by the certificate; or

                     (b)  the manufacturer’s quality management system.

41EL  Conditions imposed after issuing a conformity assessment certificate

             (1)  The Secretary may, by written notice given to a manufacturer in respect of whom a conformity assessment certificate has been issued:

                     (a)  impose new conditions on the certificate in respect of:

                              (i)  one or more kinds of medical devices covered by the certificate; or

                             (ii)  the manufacturer’s quality management system; or

                     (b)  vary or remove existing conditions.

The power may be exercised at the request of the applicant for the certificate or on the Secretary’s own initiative.

             (2)  The imposition, variation or removal of a condition under this section takes effect:

                     (a)  if the notice states that the action is necessary to prevent imminent risk of death, serious illness or serious injury—on the day on which the notice is given to the person; or

                    (aa)  in the case of an imposition or variation requested by the person, and to which paragraph (a) does not apply—on the day specified in the notice, which must be at least 20 working days after the notice is given to the person, unless the person has agreed to an earlier day; or

                   (ab)  in the case of a removal to which paragraph (a) does not apply—on the day specified in the notice, which must be at least 20 working days after the notice is given to the person, unless the person has agreed to an earlier day; or

                     (b)  in any other case—on the day specified for the purpose in the notice, being a day not earlier than 20 working days after the notice is given to the person.

             (3)  For the purposes of paragraphs (2)(aa) and (ab), the earlier day must not be earlier than the day the notice is given to the person.

Division 3Suspension of conformity assessment certificates

41EM  Suspension of conformity assessment certificates

             (1)  The Secretary may, by written notice given to the person in relation to whom a conformity assessment certificate is issued, suspend the certificate if the Secretary is satisfied that it is likely that there are grounds for revoking the certificate under section 41ET.

             (2)  The suspension may be limited to some medical devices of that kind, as specified in the notice.

             (3)  The notice must specify the period of the suspension. The period must not exceed 6 months.

Note:          The period of the suspension may be extended under section 41EO.

41EN  Notice of proposed suspension

             (1)  However, before suspending a conformity assessment certificate, the Secretary must:

                     (a)  inform the person in writing that the Secretary proposes the suspension and set out the reasons for it; and

                     (b)  give the person a reasonable opportunity to make submissions to the Secretary in relation to the proposed suspension.

             (2)  The Secretary is not to make a decision relating to the proposed suspension until the Secretary has had regard to any submissions the person makes under paragraph (1)(b).

             (3)  This section does not apply if the notice under section 41EM states that the suspension is necessary to prevent imminent risk of death, serious illness or serious injury.

41EO  Duration of suspension

             (1)  The suspension takes effect:

                     (a)  if the notice under section 41EM states that the suspension is necessary to prevent imminent risk of death, serious illness or serious injury—on the day on which the notice is given to the person; or

                     (b)  in any other case—on the day specified for the purpose in the notice, being a day not earlier than 20 working days after the notice is given to the person.

             (2)  The suspension has effect until:

                     (a)  the Secretary revokes it under section 41EP; or

                     (b)  the expiry of:

                              (i)  the period specified in the notice under section 41EM; or

                             (ii)  if the period is extended under subsection (3) of this section, the period as so extended.

Note:          Unless a suspension of a conformity assessment certificate has been revoked, the certificate is automatically revoked: see section 41ER.

             (3)  If a person in relation to whom a kind of medical device is included in the Register shows that he or she has taken steps to address the grounds for revoking the certificate under section 41ET, the Secretary may, by written notice given to the person, extend the period specified in the notice under section 41EM by a further specified period not exceeding 6 months.

41EP  Revocation of suspension

             (1)  The Secretary must revoke the suspension if the Secretary is satisfied that:

                     (a)  the ground on which the conformity assessment certificate was suspended no longer applies; and

                     (b)  there are no other grounds for suspending the certificate.

             (2)  The Secretary’s power to revoke the suspension may be exercised:

                     (a)  if:

                              (i)  the manufacturer in relation to whom the conformity assessment certificate was issued; or

                             (ii)  the person who applied for the certificate (if the applicant was not the manufacturer);

                            applies in writing to the Secretary; or

                     (b)  on the Secretary’s own initiative.

             (3)  After revoking the suspension, the Secretary must, within 20 working days after the revocation, give written notice of the revocation to the person in relation to whom the conformity assessment certificate was issued.

             (4)  If the Secretary decides, after an application is made under paragraph (2)(a), not to revoke the suspension, the Secretary must:

                     (a)  notify the applicant in writing of his or her decision within 20 working days after the decision is made; and

                     (b)  state in the notice the reasons for the decision.

41EQ  Powers of revocation of conformity assessment certificates unaffected

             (1)  This Division does not affect the Secretary’s powers to revoke a conformity assessment certificate under Division 4.

             (2)  To the extent that a suspension under this Division relates to a conformity assessment certificate to which such a revocation relates, the suspension ceases to have effect.

Division 4Revocation of conformity assessment certificates

41ER  Automatic revocation of conformity assessment certificates

                   The Secretary must, by written notice given to the person in relation to whom a conformity assessment certificate is issued, revoke the certificate if:

                     (a)  the certificate has been suspended under section 41EM; and

                     (b)  the period applying to the suspension under subsection 41EM(3) or 41EO(3) (as the case requires) expires before the suspension is revoked under section 41EP.

41ES  Immediate revocation of conformity assessment certificates

             (1)  The Secretary may, by written notice given to the manufacturer in relation to whom a conformity assessment certificate is issued, revoke the certificate if the manufacturer requests in writing the revocation of the certificate.

             (2)  If:

                     (a)  the Secretary revokes a certificate under subsection (1); and

                     (b)  before the end of the period of 90 days beginning on the day the certificate was revoked, the manufacturer requests, in writing, the Secretary to withdraw the revocation; and

                     (c)  the request is accompanied by the prescribed application fee (if any);

the Secretary may, by notice in writing given to the manufacturer, withdraw the revocation.

             (3)  If the revocation is withdrawn, the revocation is taken never to have occurred.

41ET  Revocation of conformity assessment certificates after notice of proposed revocation

             (1)  The Secretary may, by written notice given to the person in relation to whom a conformity assessment certificate is issued, revoke the certificate if:

                     (a)  the conformity assessment procedures have not been applied to medical devices of a kind to which the certificate applies; or

                     (b)  the manufacturer in relation to whom the certificate is issued refuses or fails to comply with a condition to which the certificate is subject; or

                     (c)  the Secretary gives to the person a notice under section 41JA that requires the person to give to the Secretary information or documents and the person fails to comply with that notice within a further 10 working days from the day specified in that notice; or

                     (d)  the manufacturer in respect of whom the certificate is issued no longer manufactures any of the kinds of medical devices to which the certificate applies; or

                     (e)  at least one of the following persons:

                              (i)  the person (the holder) in relation to whom the certificate is issued;

                             (ii)  a person (a manager) who makes, or participates in making, decisions that affect the whole, or a substantial part, of the holder’s affairs;

                            (iii)  if the holder is a body corporate—a major interest holder of the body corporate;

                            has:

                            (iv)  been convicted of an offence against this Act or a corresponding State law; or

                             (v)  been convicted of an offence against a law of the Commonwealth or a law of a State or Territory involving fraud or dishonesty; or

                            (vi)  been ordered to pay a pecuniary penalty for the contravention of a civil penalty provision of this Act or a corresponding State law; or

                           (vii)  been ordered to pay a pecuniary penalty for the contravention of a civil penalty provision of a law of the Commonwealth or a law of a State or Territory involving fraud or dishonesty; or

                          (viii)  breached a condition of a conformity assessment document; or

                            (ix)  had a conformity assessment document suspended or revoked; or

                             (x)  been a manager, or a major interest holder, of a body corporate in respect of which subparagraph (iv), (v), (vi), (vii), (viii) or (ix) applies, if the conduct resulting in that subparagraph applying occurred when the person was a manager or major interest holder of the body corporate; or

                      (f)  any other circumstances prescribed by the regulations for the purposes of this paragraph exist.

          (1A)  A reference in paragraph (1)(e) to a person convicted of an offence includes a reference to a person in respect of whom an order has been made relating to the offence under:

                     (a)  section 19B of the Crimes Act 1914; or

                     (b)  a corresponding provision of a law of a State or Territory.

Note:          Section 19B of the Crimes Act 1914 empowers a court that has found a person to have committed an offence to take action without proceeding to record a conviction.

          (1B)  Paragraph (1)(e) does not limit paragraph (1)(f).

             (2)  However, before revoking the certificate, the Secretary must:

                     (a)  inform the person in writing that the Secretary proposes the revocation and set out the reasons for it; and

                     (b)  give the person a reasonable opportunity to make submissions to the Secretary in relation to the proposed revocation.

             (3)  The Secretary is not to make a decision relating to the proposed revocation until the Secretary has had regard to any submissions the person makes under paragraph (2)(b).

             (4)  Nothing in this section affects the operation of Part VIIC of the Crimes Act 1914 (which includes provisions that, in certain circumstances, relieve persons from the requirement to disclose spent convictions and require persons aware of such convictions to disregard them).

41EU  Limiting revocation of conformity assessment certificates to some medical devices of a particular kind

             (1)  If the Secretary is satisfied that the ground for revoking a conformity assessment certificate applies only to:

                     (a)  some of the kinds of medical devices to which the certificate applies; or

                     (b)  some medical devices of the kinds to which the certificate applies;

the Secretary must limit the revocation to the medical devices to which that ground or any other ground for revocation applies.

             (2)  If the revocation of the certificate is so limited, the Secretary must vary the certificate so that it no longer applies to the medical devices referred to in subsection (1).

41EV  Publication of revocation etc. of conformity assessment certificates

                   The Secretary must cause to be published in the Gazette or on the Department’s website, as soon as practicable after revoking a conformity assessment certificate, or varying a conformity assessment certificate under subsection 41EU(2), a notice setting out particulars of the revocation or variation.

41EW  Date of effect of revocation etc. of conformity assessment certificates

                   If the Secretary revokes a conformity assessment certificate, or varies a conformity assessment certificate under subsection 41EU(2), the revocation or variation has effect:

                     (a)  if the revocation is under section 41ER or 41ES, or the variation relates to a ground of revocation in section 41ER or 41ES—on the day on which the notice of revocation or variation is given to the person in relation to whom the certificate was issued; or

                     (b)  in any other case—on such later day as is specified in the notice.

Part 4‑4AAustralian conformity assessment bodies

  

41EWA  Conformity assessment body determinations

             (1)  The regulations may make provision for and in relation to empowering the Secretary to make conformity assessment body determinations.

             (2)  A conformity assessment body determination is a determination that a specified Australian corporation is an Australian conformity assessment body for the purposes of this Act.

             (3)  The regulations may make provision for and in relation to the following matters:

                     (a)  applications for conformity assessment body determinations;

                     (b)  the approval by the Secretary of a form for such an application;

                     (c)  information that must accompany such an application;

                     (d)  the application fee for such an application;

                     (e)  the lapsing of such an application;

                      (f)  the assessment by the Secretary of whether a conformity assessment body determination should be made in response to such an application;

                     (g)  the assessment fee for such an assessment;

                     (h)  the duration of conformity assessment body determinations.

             (4)  A conformity assessment body determination:

                     (a)  may be of general application; or

                     (b)  may be limited to either or both of the following:

                              (i)  one or more specified medical devices;

                             (ii)  one or more specified conformity assessment procedures.

          (4A)  If under the regulations the Secretary makes a conformity assessment body determination, the Secretary must assign a unique identification number to the body.

          (4B)  The Secretary must publish a list of the Australian conformity assessment bodies on the Department’s website.

          (4C)  The Secretary may also publish on the Department’s website any information relating to Australian conformity assessment bodies and either to conformity assessment body determinations or to certification‑related activities of Australian conformity assessment bodies.

             (5)  The regulations may provide that a conformity assessment body determination is subject to:

                     (a)  the conditions prescribed by the regulations; and

                     (b)  such other conditions (if any) as are specified in the determination.

Note:          See subsections 41MN(10) to (12) and 41MNA(3) for offences and a civil penalty for a breach of the conditions.

             (6)  The following are examples of conditions that may be prescribed:

                     (a)  a condition that the body will allow an authorised person:

                              (i)  to enter, at any reasonable time, premises used by the body to carry on certification‑related activities; and

                             (ii)  while on those premises, to inspect those premises and anything on those premises that concerns certification‑related activities carried on by the body; and

                            (iii)  while on those premises, to make any still or moving image or any recording of those premises or anything on those premises that concerns certification‑related activities carried on by the body; and

                            (iv)  while on those premises, to inspect, and make copies of, any documents that concern certification‑related activities carried on by the body;

                     (b)  a condition that the body will, if requested to do so by the Secretary, give the Secretary information, or produce to the Secretary documents, that concern certification‑related activities carried on by the body.

          (6A)  The regulations may make provision for and in relation to the effect on an Australian conformity assessment body certificate of the Australian conformity assessment body ceasing to carry on certification‑related activities.

          (6B)  Without limiting subsection (6A), regulations made for the purposes of that subsection may make provision in relation to a matter by conferring on the Secretary a power to make a decision of an administrative character.

             (7)  The regulations may make provision for and in relation to empowering the Secretary to revoke, suspend or vary a conformity assessment body determination.

          (7A)  If under the regulations the Secretary suspends a conformity assessment body determination, the conditions referred to in subsection (5) continue during the suspension.

             (8)  Subsections (3) to (7) do not limit subsection (1).

             (9)  The express references in this section to the Secretary do not, by implication, prevent the regulations from empowering the Secretary to delegate any or all of the Secretary’s functions or powers under regulations made for the purposes of this section.

           (10)  If a conformity assessment body determination is in force under the regulations, the determination must be published on the Department’s website.

           (11)  A conformity assessment body determination made under the regulations is not a legislative instrument.

           (12)  Subsection 33(3AB) of the Acts Interpretation Act 1901 does not apply to the specification of an Australian corporation in a conformity assessment body determination.

Note:          Subsection 33(3AB) of the Acts Interpretation Act 1901 deals with specification by class.

41EWB  Content of Australian conformity assessment body certificates

             (1)  An Australian conformity assessment body certificate that is issued to a manufacturer of medical devices must specify whether it covers:

                     (a)  all medical devices manufactured by the manufacturer; or

                     (b)  only specified medical devices manufactured by the manufacturer.

             (2)  An Australian conformity assessment body certificate must contain any other information prescribed by the regulations for the purposes of this subsection.

             (3)  An Australian conformity assessment body certificate may be subject to conditions specified in the certificate.

41EWC  Duration of Australian conformity assessment body certificates

             (1)  An Australian conformity assessment body certificate commences on the day specified for the purpose in the certificate. The certificate must specify the period for which it is to be in force (which must be no longer than 5 years).

             (2)  An Australian conformity assessment body certificate has effect at all times:

                     (a)  unless the certificate is suspended by the Australian conformity assessment body; or

                     (b)  until the end of the period specified in the certificate, or if the Australian conformity assessment body extends that period, until the end of that extended period; or

                     (c)  until the certificate is revoked by the Australian conformity assessment body.

Extensions

             (3)  An Australian conformity assessment body that has issued an Australian conformity assessment body certificate may, in writing and on its own initiative, extend the period for which the certificate is in force.

             (4)  An extension must be no longer than 12 months.

             (5)  Only one extension may be given.

             (6)  The Australian conformity assessment body must give notice of an extension to the person to whom the certificate was issued.

41EWD  Record‑keeping

             (1)  If an Australian corporation:

                     (a)  is an Australian conformity assessment body; and

                     (b)  is required by a condition referred to in subsection 41EWA(5) to keep records relating to certification‑related activities carried on by the corporation;

the Australian corporation must keep the records at all times while the corporation is an Australian conformity assessment body.

             (2)  If the Australian corporation ceases to be an Australian conformity assessment body, the corporation must keep the records referred to in subsection (1) for 15 years after that cessation.

Offences

             (3)  An Australian corporation commits an offence if:

                     (a)  the corporation is subject to a requirement under this section; and

                     (b)  the corporation contravenes the requirement.

Penalty:  1,200 penalty units.

             (4)  An Australian corporation commits an offence if:

                     (a)  the corporation is subject to a requirement under this section; and

                     (b)  the corporation contravenes the requirement.

Penalty:  300 penalty units.

             (5)  An offence against subsection (4) is an offence of strict liability.

Part 4‑5Including medical devices in the Register

  

41F  What this Part is about

Kinds of medical devices can be included in the Register if they comply with the essential principles, and conformity assessment procedures have been applied to the kinds of devices or requirements, comparable to those procedures, have been applied to the kinds of devices (and certain other requirements are complied with).

Inclusions in the Register are subject to certain automatic conditions and the Secretary may impose further conditions.

Division 1Including medical devices in the Register

41FA  What this Division is about

Kinds of medical devices are usually included in the Register once an application is made, together with the required certification and the application passes preliminary assessment. However, applications may be selected for audit, which involves checking some or all aspects of the application and certification.

Note 1:       In some cases, an application relating to a kind of medical device will not pass preliminary assessment unless that kind of device is covered by a conformity assessment certificate under Part 4‑4: see paragraph 41FDB(2)(e).

Note 2:       Dealing in medical devices of a kind not included in the Register may be an offence or may contravene a civil penalty provision: see Division 3 of Part 4‑11.

Subdivision AApplications

41FC  Making an application

             (1)  A person may make an application to the Secretary for a kind of medical device to be included in the Register.

             (2)  An application must not contain information that is false or misleading in a material particular.

Note:          A person might also commit an offence, or contravene a civil penalty provision, if the person makes a statement in an application that is false or misleading in a material particular: see sections 41FE and 41FEA.

41FD  Matters to be certified

                   The applicant must certify that:

                     (a)  devices of the kind in question are medical devices; and

                     (b)  devices of that kind are intended for a specified purpose, as ascertained under subsection 41BD(2); and

                     (c)  the kind of device is correctly classified according to the medical device classifications; and

                     (d)  devices of that kind comply with the essential principles; and

                     (e)  the applicant:

                              (i)  has available sufficient information to substantiate that compliance with the essential principles; or

                             (ii)  has procedures in place, including a written agreement with the manufacturer of the kind of devices setting out the matters required by the regulations, to ensure that such information can be obtained from the manufacturer within the period specified in the regulations; and

                      (f)  either:

                              (i)  appropriate conformity assessment procedures have been applied to devices of that kind; or

                             (ii)  requirements, comparable to the conformity assessment procedures, have been applied to devices of that kind; and

                     (g)  the applicant:

                              (i)  has available sufficient information to substantiate the application of the procedures referred to in subparagraph (f)(i) or the requirements referred to in subparagraph (f)(ii); or

                             (ii)  has procedures in place, including a written agreement with the manufacturer of the kind of devices setting out the matters required by the regulations, to ensure that such information can be obtained from the manufacturer within the period specified in the regulations; and

                     (h)  both of the following are complied with in relation to devices of that kind:

                              (i)  the applicable provisions of the Therapeutic Goods Advertising Code;

                             (ii)  the other requirements (if any) relating to advertising applicable under Part 5‑1 or under the regulations; and

                   (ha)  if there are one or more absolute prohibitions in force for the purposes of subsection 9K(1) or (3):

                              (i)  if those prohibitions cover imports—any imports into Australia of devices of that kind by, or on behalf of the applicant, will not contravene those prohibitions; and

                             (ii)  if those prohibitions cover exports—any exports from Australia of devices of that kind by, or on behalf of the applicant, will not contravene those prohibitions; and

                            (iii)  if those prohibitions cover manufacture—any manufacture in Australia of devices of that kind by, or on behalf of the applicant, will not contravene those prohibitions; and

                            (iv)  if those prohibitions cover supplies—any supplies in Australia of devices of that kind by, or on behalf of the applicant, will not contravene those prohibitions; and

                   (hb)  if there are one or more prohibitions in force for the purposes of subsection 9K(1) or (3) that are subject to conditions:

                              (i)  if those prohibitions cover imports—any imports into Australia of devices of that kind by, or on behalf of the applicant, will not contravene those conditions; and

                             (ii)  if those prohibitions cover exports—any exports from Australia of devices of that kind by, or on behalf of the applicant, will not contravene those conditions; and

                            (iii)  if those prohibitions cover manufacture—any manufacture in Australia of devices of that kind by, or on behalf of the applicant, will not contravene those conditions; and

                            (iv)  if those prohibitions cover supplies—any supplies in Australia of devices of that kind by, or on behalf of the applicant, will not contravene those conditions; and

                      (i)  devices of that kind do not contain substances that are prohibited imports for the purposes of the Customs Act 1901; and

                    (ia)  devices of that kind are not to be used exclusively for one or more of the purposes specified under section 41BEA; and

                      (j)  the information included in or with the application is complete and correct.

Note:          See section 41BH for when a medical device complies with the essential principles, section 41BI for when conformity assessment procedures are taken not to have been applied to a medical device and section 41BIA for when requirements comparable to those procedures are taken not to have been applied to a medical device.

41FDA  Basis of certification of conformity assessment procedures

             (1)  When certifying the matter referred to in paragraph 41FD(f), the applicant must also state that the certification of the matter is based:

                     (a)  on a conformity assessment certificate that is in force; or

                     (b)  on an Australian conformity assessment body certificate that is in force; or

                     (c)  on an overseas regulator conformity assessment document that is in force.

             (2)  However, subsection (1) does not apply if devices of the kind in question are class I medical devices (within the meaning of regulations made for the purposes of this Chapter).

41FDB  Preliminary assessment of applications

             (1)  If an application is made under section 41FC for a kind of medical device to be included in the Register in relation to a person, the Secretary must carry out an assessment of whether the requirements set out in subsection (2) have been met in relation to the application.

             (2)  The requirements are as follows:

                     (a)  the application must be made:

                              (i)  in accordance with the form approved, in writing, by the Secretary for that classification of medical device; or

                             (ii)  in such other manner as is approved, in writing, by the Secretary for that classification of medical device;

                     (b)  the prescribed application fee for that classification of medical device must be paid;

                     (c)  the application must be delivered to an office of the Department specified by the Secretary;

                     (d)  the application must be accompanied by information that is:

                              (i)  of a kind determined under subsection (7) for that classification of medical device; and

                             (ii)  in a form determined under subsection (8) for that classification of medical device;

                     (e)  if regulations made for the purposes of section 41EA require the manufacturer of the kind of device to have a conformity assessment certificate relating to the kind of medical device before an application under section 41FC can be made—such a certificate is in force;

                      (f)  the applicant has certified the matters in section 41FD.

Passing preliminary assessment

             (3)  An application passes preliminary assessment if the Secretary:

                     (a)  has carried out an assessment, under subsection (1), in relation to the application; and

                     (b)  is satisfied that the requirements set out in subsection (2) have been met in relation to the application.

             (4)  If the application has not passed preliminary assessment, the Secretary must refuse the application.

Note:          The Secretary is required to give notice of the refusal: see section 41FG.

Approval of forms etc.

             (5)  For the purposes of paragraph (2)(a), the Secretary may approve different forms and different manners for making applications for different medical device classifications.

             (6)  An approval of a form may require or permit an application or information to be given in accordance with specified software requirements:

                     (a)  on a specified kind of data processing device; or

                     (b)  by way of a specified kind of electronic transmission.

Determination of kinds and forms of information

             (7)  The Secretary may, by legislative instrument, determine a kind of information for the purposes of the application of subparagraph (2)(d)(i) to medical devices of a particular classification.

             (8)  The Secretary may, by legislative instrument, determine a form of information for the purposes of the application of subparagraph (2)(d)(ii) to medical devices of a particular classification.

41FE  Criminal offences for making a false statement

             (1)  A person commits an offence if:

                     (a)  the person makes a statement (whether orally, in a document or in any other way); and

                     (b)  the person knows that the statement is false or misleading in a material particular; and

                     (c)  the statement is in or in connection with:

                              (i)  an application for including a kind of medical device in the Register under this Chapter; or

                             (ii)  a certification or purported certification under section 41FD; and

                     (d)  either:

                              (i)  the use of the kind of medical device has resulted in, will result in, or is likely to result in, harm or injury to any person; or

                             (ii)  the use of the kind of medical device, if the kind of medical device were used, would result in, or would be likely to result in, harm or injury to any person.

Penalty:  Imprisonment for 5 years or 4,000 penalty units, or both.

Note 1:       A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A.

Note 2:       For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

             (4)  A person commits an offence if:

                     (a)  the person makes a statement (whether orally, in a document or in any other way); and

                     (b)  the person knows that the statement is false or misleading in a material particular; and

                     (c)  the statement is in or in connection with:

                              (i)  an application for including a kind of medical device in the Register under this Chapter; or

                             (ii)  a certification or purported certification under section 41FD.

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.

             (5)  A person commits an offence if:

                     (a)  the person makes a statement (whether orally, in a document or in any other way); and

                     (b)  the statement is false or misleading in a material particular; and

                     (c)  the statement is in or in connection with:

                              (i)  an application for including a kind of medical device in the Register under this Chapter; or

                             (ii)  a certification or purported certification under section 41FD.

Penalty:  100 penalty units.

             (6)  An offence against subsection (5) is an offence of strict liability.

41FEA  Civil penalty for making a false statement

                   A person contravenes this section if:

                     (a)  the person makes a statement (whether orally, in a document or in any other way); and

                     (b)  the statement is false or misleading in a material particular; and

                     (c)  the statement is in or in connection with:

                              (i)  an application for including a kind of medical device in the Register under this Chapter; or

                             (ii)  a certification or purported certification under section 41FD.

Maximum civil penalty:

                     (a)  for an individual—5,000 penalty units; and

                     (b)  for a body corporate—50,000 penalty units.

Subdivision BIncluding kinds of medical devices in the Register

41FF  Obligation to include kinds of medical devices in the Register

             (1)  If:

                     (a)  an application for a kind of medical device to be included in the Register in relation to a person has passed preliminary assessment; and

                     (b)  the application has not been selected for audit under section 41FH;

the Secretary must include the kind of device in the Register in relation to the person.

          (1A)  However, the Secretary must not include the kind of device in the Register in relation to the person if the Secretary is satisfied that the kind of device is to be used exclusively for one or more of the purposes specified under section 41BEA.

             (2)  As soon as practicable after the kind of device has been included in the Register, the Secretary must make available to the applicant a certificate of the inclusion of the kind of device in the Register.

             (3)  The certificate must specify the day on which the inclusion of the kind of device in the Register commences.

41FG  Notification of unsuccessful applications

             (1)  This section applies if an application under subsection 41FC(1) for a kind of medical device to be included in the Register:

                     (a)  is refused under subsection 41FDB(4); or

                     (b)  is refused under subsection 41FF(1A).

             (2)  The Secretary must notify the applicant in writing, of the refusal within 20 working days after the application has been received and the prescribed application fee has been paid.

Subdivision CAuditing of applications

41FH  Selecting applications for auditing

          (1A)  This section applies to applications that have passed preliminary assessment.

             (1)  The Secretary:

                     (a)  must select for auditing any application for a kind of medical device to be included in the Register that is an application of the kind prescribed by the regulations; and

                     (b)  may select for auditing any other application for a kind of medical device to be included in the Register.

Note:          An application audit assessment fee is payable in respect of any application that the Secretary must select for auditing: see Part 4‑10.

             (2)  If an application is selected for auditing:

                     (a)  the Secretary must give the applicant a written notice (the selection notice) that:

                              (i)  informs the applicant of the selection; and

                             (ii)  requires the applicant to provide, within the period specified in the notice, information or documents that the Secretary is satisfied is relevant to the audit; and

                     (b)  the application must be dealt with under this Subdivision and not under Subdivision B.

             (3)  The selection notice must be given within:

                     (a)  20 working days after the application is made and the prescribed application fee is paid; or

                     (b)  if the regulations prescribe a longer period for that kind of application—that longer period.

             (4)  Subparagraph (2)(a)(ii) does not limit section 41JA (Secretary may require information).

41FI  Auditing of applications

             (1)  In auditing the application, the Secretary may consider all or some aspects of one or both of the following matters:

                     (a)  whether the application is in accordance with Subdivision A;

                     (b)  whether matters as to which the applicant has certified under section 41FD are correct.

          (1A)  In auditing the application, the Secretary may, by written notice given to the applicant, require the applicant:

                     (a)  to deliver to the office to which the application was made a reasonable number of samples of the kind of medical device to which the application relates within the period, of not less than 14 days after the day the notice is given, specified in the notice; and

                     (b)  to do so in a manner specified in the notice.

             (2)  The Secretary must decide to include the kind of device to which the application relates in the Register, in relation to the person to whom the application relates, if the Secretary is satisfied as to all such aspects considered in the audit.

             (3)  The Secretary must decide not to include the kind of device to which the application relates in the Register if the Secretary is not so satisfied.

41FIA  Certificates issued by Australian conformity assessment bodies

             (1)  If:

                     (a)  a section 41FC application is made for a kind of medical device to be included in the Register; and

                     (b)  the application has been selected for audit; and

                     (c)  a person has obtained a certificate issued by an Australian conformity assessment body to the effect that the body is satisfied that an appropriate conformity assessment procedure has been applied to devices of that kind; and

                     (d)  the certificate has been given to the Secretary; and

                     (e)  if the conformity assessment body determination that relates to the body is limited as mentioned in paragraph 41EWA(4)(b)—the Secretary is satisfied that the certificate has been issued consistently with the determination;

the Secretary may have regard to the certificate in auditing the application.

             (2)  This section does not, by implication, limit the matters to which the Secretary may have regard.

41FJ  Procedure following audits

                   After auditing the application, the Secretary must:

                     (a)  notify the applicant in writing of his or her decision within 20 working days after the decision is made; and

                     (b)  if the decision is not to include the kind of device to which the application relates in the Register—state in the notice the reasons for the decision; and

                     (c)  if the decision is to include the kind of device in the Register and all assessment fees for the application that are due and payable have been paid:

                              (i)  include the kind of device in the Register, in relation to the person in relation to whom the application was made; and

                             (ii)  give the applicant a certificate of the inclusion of the kind of device in the Register.

41FK  Lapsing of applications

                   An application that has been selected for auditing lapses if:

                     (a)  the applicant fails to comply with a notice under section 41FH within 10 working days after the end of the period specified in the notice; or

                     (b)  the applicant does not comply with a requirement by the Secretary under subsection 41FI(1A) to deliver to the office to which the application was made a reasonable number of samples of the kind of medical device to which the application relates; or

                     (c)  the applicant fails to comply with a notice under section 41JA to give information relating to devices of that kind to the Secretary within a further 10 working days from the day specified in the notice; or

                     (d)  information given to the Secretary by, or on behalf of, the applicant in connection with the application, including information given for the purpose of a requirement under section 41JA, is false or misleading in a material particular; or

                     (e)  the applicant fails to pay an assessment fee for the application in accordance with section 41LB or 41LC.

Subdivision DMiscellaneous

41FKA  Medical devices (priority applicant) determinations

             (1)  The regulations may make provision for and in relation to empowering the Secretary to make medical devices (priority applicant) determinations.

             (2)  A medical devices (priority applicant) determination is a determination that, for the purposes of this Act, a specified person is a priority applicant in relation to any section 41FC application that may be made by the person for the inclusion in the Register of a medical device of a kind specified in the determination.

             (3)  The regulations may make provision for and in relation to the following matters:

                     (a)  applications for medical devices (priority applicant) determinations;

                     (b)  the approval by the Secretary of a form for such an application;

                     (c)  information that must accompany such an application;

                     (d)  the application fee for such an application;

                     (e)  empowering the Secretary to give the applicant a written notice requiring the applicant to give to the Secretary specified information or documents in connection with the application within a specified period (which must be at least 10 working days after the notice is given to the applicant).

             (4)  The regulations may make provision for and in relation to the following matters:

                     (a)  empowering the Secretary to revoke a medical devices (priority applicant) determination;

                     (b)  the consequences of the revocation of a medical devices (priority applicant) determination.

             (5)  Subsections (3) and (4) do not limit subsection (1).

             (6)  The regulations may make provision for and in relation to the priority to be given by the Secretary to consideration of a section 41FC application where the applicant is a priority applicant.

             (7)  The regulations may provide that, if:

                     (a)  a person is a priority applicant in relation to a section 41FC application made by the person; and

                     (b)  a decision is made on the application;

a statement setting out the decision may be published on the Department’s website.

             (8)  The express references in this section to the Secretary do not, by implication, prevent the regulations from empowering the Secretary to delegate any or all of the Secretary’s functions or powers under regulations made for the purposes of this section.

             (9)  If a medical devices (priority applicant) determination is in force under the regulations, the determination may be published on the Department’s website.

           (10)  A medical devices (priority applicant) determination made under the regulations is not a legislative instrument.

           (11)  Subsection 33(3AB) of the Acts Interpretation Act 1901 does not apply to the specification of a person in a medical devices (priority applicant) determination.

Note:          Subsection 33(3AB) of the Acts Interpretation Act 1901 deals with specification by class.

41FL  Device number

                   If a kind of medical device is included in the Register, the Secretary is to assign a unique device number to it.

41FM  Duration of inclusion in the Register

             (1)  The inclusion of a kind of medical device in the Register commences on the day specified for the purpose in the certificate under section 41FF or 41FJ.

             (2)  The inclusion of a kind of medical device in the Register has effect at all times:

                     (a)  unless the kind of device is suspended from the Register under Division 1 of Part 4‑6; or

                     (b)  until entry of the kind of device is cancelled from the Register under Division 2 of Part 4‑6.

Division 2Conditions

Note:       Breaching conditions of the inclusion of a kind of medical device may lead to suspension or cancellation of the entry of the kind of device from the Register (see Part 4‑6), may be an offence (see subsections 41MN(1), (4) and (4A)), and may contravene a civil penalty provision (see subsection 41MNA(1)).

41FN  Conditions applying automatically

Entry and inspection powers

             (1)  The inclusion of a kind of medical device in the Register is subject to the conditions that the person in relation to whom the kind of device is included in the Register will:

                     (a)  allow an authorised person:

                              (i)  to enter, at any reasonable time, any premises (including premises outside Australia) at which that person or any other person deals with medical devices of that kind; and

                             (ii)  while on those premises, to inspect those premises and medical devices of any kind on those premises and to examine, take measurements of, conduct tests on, require tests to be conducted on or take samples of medical devices of any kind on those premises or any thing on those premises that relates to medical devices of any kind; and

                            (iii)  while on those premises, to make any still or moving image or any recording of those premises or any thing on those premises; and

                     (b)  if requested to do so by an authorised person, produce to the person such documents relating to devices of the kind included in the Register as the person requires and allow the person to copy the documents.

Delivery of samples

             (2)  The inclusion of a kind of medical device in the Register is subject to a condition that the person in relation to whom the kind of device is included in the Register will deliver a reasonable number of samples of the kind of device if the Secretary so requests:

                     (a)  within the period specified in the request; and

                     (b)  in accordance with any other requirements specified in the request.

The period specified in the request must include at least 10 working days.

Availability etc. of information

             (3)  The inclusion of a kind of medical device in the Register is subject to conditions that:

                     (a)  at all times while the inclusion in the Register has effect, the person in relation to whom the kind of device is included in the Register:

                              (i)  has available sufficient information to substantiate compliance with the essential principles; or

                             (ii)  has procedures in place, including a written agreement with the manufacturer of the kind of devices setting out the matters required by the regulations, to ensure that such information can be obtained from the manufacturer within the period specified in the regulations; and

                     (b)  at all times while the inclusion in the Register has effect, the person in relation to whom the kind of device is included in the Register:

                              (i)  has available sufficient information to substantiate that the conformity assessment procedures have been applied to the kind of medical device or that requirements, comparable to those procedures, have been applied to the kind of medical device to the satisfaction of an overseas regulator; or

                             (ii)  has available information relating to changes to the kind of medical device, the product range, and quality management system, of the manufacturer of the device; or

                            (iii)  has procedures in place, including a written agreement with the manufacturer of the kind of devices setting out the matters required by the regulations, to ensure that such information can be obtained from the manufacturer within the period specified in the regulations; and

                     (c)  at any time while the inclusion in the Register has effect, the person in relation to whom the kind of device is included in the Register will, if asked to do so by the Secretary, give the information to the Secretary; and

                     (d)  the person in relation to whom the kind of device is included in the Register will give information of a kind mentioned in subsection 41MP(2) or 41MPA(2) to the Secretary within the period specified in the regulations; and

                     (e)  the person in relation to whom the kind of device is included in the Register will give the manufacturer of the kind of medical device information relevant to:

                              (i)  the manufacturer’s obligations under the conformity assessment procedures or requirements comparable to those procedures; and

                             (ii)  whether medical devices of that kind comply with the essential principles.

             (4)  The regulations may prescribe the amount, standard or kind of information or evidence required for the purposes of paragraphs (3)(c), (d) and (e).

Advertising material

             (5)  The inclusion of a kind of medical device in the Register is subject to a condition that advertising material relating to medical devices of that kind is consistent with the intended purpose as certified under section 41FD.

Conditions prescribed by the regulations

          (5A)  The inclusion of a kind of medical device in the Register is subject to such conditions (if any) as are prescribed by the regulations.

Conditions determined by the Minister

          (5B)  The inclusion of a kind of medical device in the Register is subject to such conditions (if any) as are determined under subsection (5C).

          (5C)  The Minister may, by legislative instrument, determine one or more conditions for the purposes of subsection (5B).

Conditions do not limit other conditions

             (6)  A condition imposed under this section is in addition to any conditions imposed under this Division.

41FO  Conditions imposed when kinds of medical devices are included in the Register

             (1)  If the Secretary includes a kind of medical device in the Register in relation to a person, the Secretary may, in writing, impose conditions on the inclusion of the kind of device in the Register.

             (2)  Conditions referred to in subsection (1) may relate to:

                     (a)  manufacture of devices of that kind; or

                     (b)  custody, intended purpose, supply, disposal or destruction of devices of that kind; or

                     (c)  keeping of records relating to devices of that kind, including records relating to the tracking and location of devices of that kind after their supply; or

                     (d)  matters dealt with in, or matters additional to matters dealt with in, the essential principles; or

                     (e)  such other matters relating to devices of that kind as the Secretary thinks appropriate.

41FP  Conditions imposed after kinds of medical devices are included in the Register

             (1)  The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register:

                     (a)  impose new conditions on including the kind of device in the Register under this Chapter; or

                     (b)  vary or remove existing conditions.

The power may be exercised at the person’s request or on the Secretary’s own initiative.

             (2)  The imposition, variation or removal of a condition under this section takes effect:

                     (a)  if the notice states that the action is necessary to prevent imminent risk of death, serious illness or serious injury—on the day on which the notice is given to the person; or

                    (aa)  in the case of an imposition or variation requested by the person, and to which paragraph (a) does not apply—on the day specified in the notice, which must be at least 20 working days after the notice is given to the person, unless the person has agreed to an earlier day; or

                   (ab)  in the case of a removal to which paragraph (a) does not apply—on the day specified in the notice, which must be at least 20 working days after the notice is given to the person, unless the person has agreed to an earlier day; or

                     (b)  in any other case—on the day specified for the purpose in the notice, being a day not earlier than 20 working days after the notice is given to the person.

             (3)  For the purposes of paragraphs (2)(aa) and (ab), the earlier day must not be earlier than the day the notice is given to the person.

Part 4‑6Suspension and cancellation from the Register

Division 1Suspension from the Register

Subdivision AGeneral power of suspension

41G  What this Part is about

Inclusions in the Register may be suspended in certain circumstances, such as when a conformity assessment document is suspended. A kind of medical device that is suspended is taken not to be included in the Register for most purposes.

Inclusions in the Register may also be cancelled in certain circumstances.

41GA  Suspension of kinds of medical devices from the Register

             (1)  The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, suspend the kind of device from the Register if:

                     (a)  the Secretary is satisfied that:

                              (i)  there is a potential risk of death, serious illness or serious injury if the kind of device continues to be included in the Register; and

                             (ii)  it is likely that the person will, within the period of the suspension, be able to take the action necessary to ensure that the kind of device would not cause a potential risk of death, serious illness or serious injury if it were to continue to be included in the Register; or

                     (b)  the Secretary is satisfied that it is likely that there are grounds for cancelling the entry of the kind of device from the Register under Division 2 (other than under paragraph 41GL(a), (d) or (f) or section 41GM).

             (2)  The suspension may be limited to some medical devices of that kind, as specified in the notice.

             (3)  The notice must specify the period of the suspension. The period must not exceed 6 months.

Note:          The period of the suspension may be extended under section 41GC.

             (4)  The Secretary must cause to be published in the Gazette or on the Department’s website, as soon as practicable after the suspension, a notice setting out particulars of the suspension.

41GB  Notice of proposed suspension must be given in certain cases

             (1)  However, before suspending a kind of medical device from the Register because it is likely that there are grounds for cancelling the entry of the kind of device from the Register under section 41GN, the Secretary must:

                     (a)  inform the person by written notice that the Secretary proposes the suspension and set out the reasons for it; and

                     (b)  give the person a reasonable opportunity to make submissions to the Secretary in relation to the proposed suspension.

             (2)  The Secretary is not to make a decision relating to the proposed suspension until the Secretary has had regard to any submissions the person makes under paragraph (1)(b).

41GC  Duration of suspension

             (1)  The suspension takes effect:

                     (a)  if the notice under subsection 41GA(1) states that the suspension is necessary to prevent a potential risk of death, serious illness or serious injury—on the day on which the notice is given to the person; or

                     (b)  in any other case—on the day specified for the purpose in the notice, being a day not earlier than 20 working days after the notice is given to the person.

             (2)  The suspension has effect until:

                     (a)  the Secretary revokes it under section 41GD; or

                     (b)  the end of:

                              (i)  the period specified in the notice under subsection 41GA(3); or

                             (ii)  if the period is extended under subsection (3) of this section, the period as so extended.

Note:          Unless a suspension of a kind of medical device has been revoked, the entry of the kind of medical device is automatically cancelled from the Register: see section 41GK.

             (3)  If a person in relation to whom a kind of medical device is included in the Register shows that he or she has taken steps to remove the grounds for cancelling the entry of the kind of device from the Register under section 41GN, the Secretary may, by written notice given to the person, extend the period specified in the notice under subsection 41GA(1) by a further specified period not exceeding 6 months.

             (4)  The Secretary must cause to be published in the Gazette or on the Department’s website, as soon as practicable after the extension, a notice setting out particulars of the extension.

41GD  Revocation of suspension

             (1)  The Secretary must revoke the suspension if the Secretary is satisfied that:

                     (a)  the ground on which the kind of medical device concerned was suspended from the Register no longer applies; and

                     (b)  there are no other grounds for suspending the kind of device from the Register.

             (2)  The Secretary’s power to revoke the suspension may be exercised:

                     (a)  if the person in relation to whom the kind of medical device concerned is included in the Register applies in writing to the Secretary; or

                     (b)  on the Secretary’s own initiative.

             (3)  After revoking the suspension, the Secretary must:

                     (a)  within 20 working days after the revocation, give written notice of the revocation to the person in relation to whom the kind of medical device concerned is included in the Register; and

                     (b)  as soon as practicable after the revocation, cause to be published in the Gazette or on the Department’s website a notice setting out particulars of the revocation.

             (4)  If the Secretary decides, after an application is made under paragraph (2)(a), not to revoke the suspension, the Secretary must:

                     (a)  notify the applicant in writing of his or her decision within 20 working days after the decision is made; and

                     (b)  state in the notice the reasons for the decision.

41GE  Treating applications for revocation as having been refused

             (1)  The applicant for the suspension to be revoked may give the Secretary written notice that the applicant wishes to treat the application as having been refused if:

                     (a)  a period is prescribed under paragraph 63(2)(dd) for the Secretary to make a decision on the application; and

                     (b)  at the end of the period, the Secretary has not made a decision.

             (2)  The notice may be given at any time before the Secretary makes a decision on the application.

             (3)  If a notice has been given, this Act (except for subsection 60(5)) has effect as if:

                     (a)  the Secretary had decided not to revoke the suspension; and

                     (b)  the Minister had made a decision under subsection 60(3) confirming the decision of the Secretary; and

                     (c)  the Minister’s decision had been made on the day on which notice was given to the Secretary.

Subdivision BSuspension as a result of suspension of conformity assessment document

41GF  Suspension where conformity assessment certificate suspended

             (1)  The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, suspend the kind of device from the Register if the conformity assessment certificate applying to that kind of device is suspended under Division 3 of Part 4‑4.

             (2)  If the suspension under Division 3 of Part 4‑4 is limited to some medical devices of that kind, the suspension under this section is taken to be limited to the same extent.

             (3)  The Secretary must cause to be published in the Gazette or on the Department’s website, as soon as practicable after the suspension, a notice setting out particulars of the suspension.

41GFA  Suspension where other certificates or documents are suspended

             (1)  The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, suspend the kind of device from the Register if:

                     (a)  an Australian conformity assessment body certificate that applies to the kind of device is suspended by the Australian conformity assessment body; or

                     (b)  an overseas regulator conformity assessment document that applies to the kind of device is suspended by the overseas regulator.

             (2)  However, before suspending the kind of device from the Register, the Secretary must:

                     (a)  inform the person in writing that the Secretary proposes the suspension and set out the reasons for it; and

                     (b)  give the person a reasonable opportunity to make submissions to the Secretary in relation to the proposed suspension.

             (3)  The Secretary is not to make a decision relating to the proposed suspension until the Secretary has had regard to any submissions the person makes under paragraph (2)(b).

             (4)  The Secretary must cause to be published on the Department’s website, as soon as practicable after the suspension, a notice setting out particulars of the suspension.

41GG  Duration of suspension

             (1)  A suspension under section 41GF or 41GFA takes effect on the day on which the notice is given to the person.

             (2)  The suspension has effect until the Secretary revokes it under section 41GH.

41GH  Revocation of suspension

             (1)  The Secretary must revoke a suspension under section 41GF if:

                     (a)  the suspension under Division 3 of Part 4‑4 ceases to have effect; and

                     (b)  the Secretary is satisfied that there are no other grounds for suspending the kind of device from the Register.

          (1A)  The Secretary may revoke a suspension under section 41GFA if:

                     (a)  either:

                              (i)  the suspension referred to in paragraph 41GFA(1)(a) or (b) ends; or

                             (ii)  the person in relation to whom the kind of medical device is included in the Register provides the Secretary with another conformity assessment document that applies to the kind of device; and

                     (b)  the Secretary is satisfied that there are no other grounds for suspending the kind of device from the Register.

             (2)  After making a revocation under subsection (1) or (1A), the Secretary must:

                     (a)  within 20 working days after the revocation, give written notice of the revocation to the person in relation to whom the kind of medical device concerned is included in the Register; and

                     (b)  as soon as practicable after the revocation, cause to be published in the Gazette or on the Department’s website a notice setting out particulars of the revocation.

Subdivision CEffect of suspension

41GI  Effect of suspension

                   If all or some medical devices of a particular kind are suspended, they are taken, for the purposes of this Act (other than Division 2 of Part 4‑5, this Division and Part 4‑8), not to be included in the Register while the suspension has effect.

Note:          Dealing in medical devices that are not included in the Register may be an offence or may contravene a civil penalty provision: see Division 3 of Part 4‑11.

41GJ  Powers of cancellation from Register unaffected

             (1)  This Subdivision does not affect the Secretary’s powers to cancel the entry of kinds of medical devices from the Register under Division 2.

             (2)  To the extent that a suspension under this Division relates to medical devices to which such a cancellation relates, the suspension ceases to have effect.

Division 2Cancellation of entries from the Register

41GK  Automatic cancellation of entries of kinds of medical devices from the Register

             (1)  The Secretary must, by written notice given to the person in relation to whom a kind of medical device is included in the Register, cancel the entry of the kind of device from the Register if:

                     (a)  the kind of device has been suspended from the Register under section 41GA, and the period applying to the suspension under subsection 41GA(3) or 41GC(3) (as the case requires) expires before the suspension is revoked under section 41GD; or

                     (b)  a conformity assessment certificate applying to that kind of device is revoked under Division 4 of Part 4‑4.

             (2)  The Secretary must, by written notice given to the person in relation to whom a kind of medical device is included in the Register, cancel the entry of the kind of device from the Register if the Secretary is satisfied that:

                     (a)  if there are one or more absolute prohibitions in force for the purposes of subsection 9K(1) or (3)—imports into Australia, exports from Australia, the manufacture in Australia or supplies in Australia of the kind of device would contravene one or more of those prohibitions; or

                     (b)  if there are one or more prohibitions in force for the purposes of subsection 9K(1) or (3) that are subject to conditions—imports into Australia, exports from Australia, the manufacture in Australia or supplies in Australia of the kind of device would contravene one or more of those conditions.

41GL  Immediate cancellation of entries of kinds of medical devices from the Register

                   The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, cancel the entry of the kind of device from the Register if:

                     (a)  the Secretary is satisfied that there would be an imminent risk of death, serious illness or serious injury if the kind of device continues to be included in the Register; or

                     (b)  devices of that kind are no longer therapeutic goods; or

                     (c)  devices of that kind are no longer medical devices; or

                    (ca)  the kind of medical device is covered by an exemption under paragraph 41HA(1)(b); or

                     (d)  the person requests in writing the cancellation of the entry of the kind of device from the Register; or

                     (e)  the Secretary is satisfied that a statement made in or in connection with:

                              (i)  the application for including the kind of device in the Register; or

                             (ii)  the certification or purported certification under section 41FD relating to the application;

                            was false or misleading in a material particular; or

                      (f)  the annual charge payable under subsection 4(1B) of the Therapeutic Goods (Charges) Act 1989 in respect of the inclusion of the kind of device in the Register is not paid within 20 working days after it becomes payable; or

                     (g)  the person contravenes a direction, or a condition of a direction, given to the person under subsection 42DV(1) in relation to the advertising of the kind of device and the Secretary is satisfied that the contravention is significant; or

                    (ga)  if the person is a body corporate—a related body corporate of the person contravenes a direction, or a condition of a direction, given to the related body corporate under subsection 42DV(1) in relation to the advertising of the kind of device and the Secretary is satisfied that the contravention is significant; or

                     (h)  there is a breach, involving the kind of device, of an applicable provision of the Therapeutic Goods Advertising Code or any other requirement relating to advertising applicable under Part 5‑1 or under the regulations, and the Secretary is satisfied that:

                              (i)  the breach is significant; and

                             (ii)  as a result of the breach, the presentation of devices of that kind is misleading to a significant extent.

41GLA  Revocation of cancellation of entries upon request

             (1)  If:

                     (a)  the Secretary cancels the entry of a kind of medical device because of the request of a person made under paragraph 41GL(d); and

                     (b)  before the end of the period of 90 days beginning on the day the kind of device ceased to be included in the Register, the person requests, in writing, the Secretary to revoke the cancellation; and

                     (c)  the request is accompanied by the prescribed application fee (if any);

the Secretary may, by notice in writing given to the person, revoke the cancellation.

             (2)  If the cancellation is revoked, the cancellation is taken never to have occurred.

41GLB  Revocation of cancellation of entries—payment of annual charge

             (1)  If:

                     (a)  the Secretary cancels the entry of a kind of medical device because the annual charge payable by a person under subsection 4(1B) of the Therapeutic Goods (Charges) Act 1989 in respect of the inclusion of the kind of device in the Register was not paid within 20 working days after it becomes payable; and

                     (b)  before the end of the period of 90 days beginning on the day the kind of device ceased to be included in the Register, the person in relation to whom the kind of device was included in the Register requests, in writing, the Secretary to revoke the cancellation; and

                     (c)  the annual charge payable under subsection 4(1B) of the Therapeutic Goods (Charges) Act 1989 in respect of the inclusion of the kind of device in the Register has been paid; and

                     (d)  the request is accompanied by the prescribed application fee (if any);

the Secretary may, by notice in writing given to the person, revoke the cancellation.

             (2)  If the cancellation is revoked, the cancellation is taken never to have occurred.

41GM  Cancellation of entries of kinds of medical devices from the Register after section 41JA notice

             (1)  The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, cancel the entry of the kind of device from the Register if:

                     (a)  the Secretary gives to the person a notice under section 41JA requiring the person to give to the Secretary information or documents relating to the kind of device; and

                     (b)  the notice under section 41JA is given for the purposes of ascertaining whether any of the certifications by the person under section 41FD in relation to the kind of device are incorrect; and

                     (c)  the person fails to comply with the notice under section 41JA within a further 10 working days from the day specified in that notice.

             (2)  The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, cancel the entry of the kind of device from the Register if:

                     (a)  the Secretary gives to the person a notice under section 41JA requiring the person to give to the Secretary information or documents relating to whether medical devices of that kind are being:

                              (i)  supplied in Australia; or

                             (ii)  imported into Australia; or

                            (iii)  exported from Australia; and

                     (b)  either:

                              (i)  the information or documents given are to the effect that medical devices of that kind are not being supplied in Australia, imported into Australia or exported from Australia; or

                             (ii)  the person fails to comply with the notice under section 41JA within a further 10 working days from the day specified in that notice.

41GN  Cancellation of entries of kinds of medical devices from the Register after notice of proposed cancellation

             (1)  The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, cancel the entry of the kind of device from the Register if:

                     (a)  medical devices that were devices of that kind when the kind of device was included in the Register have changed so those medical devices are no longer devices of that kind; or

                     (b)  the person in relation to whom the kind of medical device is included in the Register refuses or fails to comply with a condition to which that inclusion is subject; or

                     (c)  the Secretary gives to the person a notice under section 41JA:

                              (i)  that requires the person to give to the Secretary information or documents relating to the kind of device; and

                             (ii)  in respect of which section 41GM does not apply;

                            and the person fails to comply with that notice within a further 10 working days from the day specified in that notice; or

                     (d)  the person contravenes subsection 41MP(1) or 41MPA(1) in relation to the kind of device; or

                     (e)  the Secretary is satisfied that the safety or performance of the kind of device is unacceptable; or

                      (f)  the Secretary is satisfied that any certification, or part of a certification, under section 41FD in relation to the application for inclusion of the kind of device in the Register is incorrect, or is no longer correct, in a material particular; or

                     (g)  a conformity assessment document that applies to the kind of device expires; or

                     (h)  either of the following applies:

                              (i)  an Australian conformity assessment body certificate that applies to the kind of device is revoked by the Australian conformity assessment body;

                             (ii)  an overseas regulator conformity assessment document that applies to the kind of device is revoked by the overseas regulator; or

                      (i)  the person contravenes a direction, or a condition of a direction, given to the person under subsection 42DV(1) in relation to the advertising of the kind of device; or

                      (j)  if the person is a body corporate—a related body corporate of the person contravenes a direction, or a condition of a direction, given to the related body corporate under subsection 42DV(1) in relation to the advertising of the kind of device; or

                     (k)  either of the following has not been complied with in relation to the kind of device:

                              (i)  an applicable provision of the Therapeutic Goods Advertising Code;

                             (ii)  any other requirement relating to advertising applicable under Part 5‑1 or the regulations.

             (2)  However, before cancelling the entry of the kind of device from the Register, the Secretary must:

                     (a)  inform the person in writing that the Secretary proposes the cancellation and set out the reasons for it; and

                     (b)  give the person a reasonable opportunity to make submissions to the Secretary in relation to the proposed cancellation.

             (3)  The Secretary is not to make a decision relating to the proposed cancellation until the Secretary has had regard to any submissions the person makes under paragraph (2)(b).

41GO  Limiting cancellation of entries from Register to some medical devices of a particular kind

             (1)  If the Secretary is satisfied that the ground for cancelling the entry of a kind of medical device from the Register applies only to some medical devices of that kind, the Secretary must limit the cancellation to the medical devices to which that ground or any other ground for cancellation applies.

             (2)  If the cancellation of the entry of a kind of medical device from the Register is limited to some medical devices of that kind, the Secretary:

                     (a)  must vary the entry in the Register accordingly; and

                     (b)  must not delete the entry from the Register because of the cancellation.

41GP  Publication of cancellation of entry from Register

                   The Secretary must cause to be published in the Gazette or on the Department’s website, as soon as practicable after cancelling an entry from the Register of a kind of medical device, or of some devices of a particular kind, a notice setting out particulars of the cancellation.

41GQ  Date of effect of cancellation of entries from Register

                   If the Secretary cancels an entry of a kind of medical device, or some devices of a particular kind, from the Register, the cancellation has effect:

                     (a)  if the cancellation is under section 41GK or 41GL—on the day on which the notice of cancellation is given to the person in relation to whom the kind of device was included in the Register; or

                     (b)  in any other case—on such later day as is specified in the notice, being a day not earlier than 20 working days after the notice is given to the person.

Part 4‑6AExempting medical devices to deal with emergencies

  

41GR  What this Part is about

The Minister may exempt certain medical devices from various provisions of this Chapter so that the devices may be stockpiled to deal with possible future emergencies or made available urgently to deal with actual emergencies.

Note 1:       There are offences and civil penalty provisions related to the making of exemptions under this Part: see Division 3A of Part 4‑11.

Note 2:       Some of the other provisions of this Act about medical devices exempt under this Part are:

(a)    section 41JCA (providing information to the Secretary); and

(b)    section 41KA (public notification and recall of medical devices); and

(c)    section 46A (search of premises).

41GS  Minister may make exemptions

             (1)  The Minister may, by writing, exempt specified kinds of medical devices from the operation of the following:

                     (a)  Division 1 of Part 4‑2 (essential principles);

                     (b)  Division 1 of Part 4‑3 (conformity assessment procedures);

                     (c)  Part 4‑4 (conformity assessment certificates);

                     (d)  Part 4‑5 (including medical devices in the Register).

          (1A)  The Minister may exempt devices under subsection (1) only if the Minister is satisfied of the matter in subsection (2) or (2A).

             (2)  The matter in this subsection is that in the national interest, the exemption should be made so that:

                     (a)  the devices may be stockpiled as quickly as possible in order to create a preparedness to deal with a potential threat to public health that may be caused by a possible future emergency; or

                     (b)  the devices can be made available urgently in Australia in order to deal with an actual threat to public health caused by an emergency that has occurred.

          (2A)  The matter in this subsection is that:

                     (a)  a national emergency declaration is in force; and

                     (b)  either of the following apply:

                              (i)  the exemption should be made so that the devices may be stockpiled to deal with a potential threat to public health that may be caused by the emergency to which the national emergency declaration relates;

                             (ii)  the exemption should be made so that the devices can be made available urgently in Australia in order to deal with an actual threat to public health caused by the emergency to which the national emergency declaration relates; and

                     (c)  the Minister is satisfied that the exemption is in the national interest.

Period of exemption

             (3)  An exemption under subsection (1) comes into force:

                     (a)  on the day the exemption is made; or

                     (b)  on a later day specified in the exemption.

             (4)  An exemption under subsection (1) remains in force for the period specified in the exemption, unless revoked earlier.

Note:          Section 41GU deals with variation and revocation of the exemption.

Effect of inclusion of kind of medical device in the Register

             (5)  An exemption under subsection (1) ceases to have effect in relation to a particular kind of medical device when that kind of medical device becomes included in the Register under Part 4‑5.

Exemption not a legislative instrument

             (6)  An exemption under subsection (1) is not a legislative instrument.

Disregard section 41BE

             (7)  For the purposes of this Act, disregard section 41BE in working out the kinds of medical devices covered by an exemption under subsection (1) of this section.

41GT  Conditions of exemptions

                   An exemption under section 41GS is subject to conditions specified in the exemption about any of the following:

                     (a)  the quantity of medical devices that are exempt;

                     (b)  the source of those medical devices;

                     (c)  the persons or class of persons who may import, manufacture, supply or export those medical devices;

                     (d)  the supply of those medical devices (including the persons or class of persons to whom medical devices may be supplied for use and the circumstances under which a stockpile of medical devices may be supplied for use);

                     (e)  the storage and security of those medical devices;

                    (ea)  compliance with the requirements referred to in subsection 41CA(3) (about unique device identifiers of medical devices);

                      (f)  the keeping and disclosure of, and access to, records about those medical devices;

                     (g)  the disposal of those medical devices;

                     (h)  the manner in which any of those medical devices are to be dealt with if a condition of the exemption is breached;

                      (i)  any other matters that the Minister thinks appropriate.

Whether or not medical devices are exempt under section 41GS is not affected by whether or not there is a breach of a condition under this section in relation to those medical devices.

Note 1:       There are offences and civil penalty provisions related to the breach of a condition of an exemption: see Division 3A of Part 4‑11.

Note 2:       Section 41GU deals with variation and revocation of the conditions.

41GU  Variation or revocation of exemption

Variation of exemption

             (1)  The Minister may, by writing, vary an exemption made under section 41GS by removing specified kinds of medical devices from the exemption.

Revocation of exemption

             (2)  The Minister may, by writing, revoke an exemption made under section 41GS.

Variation or revocation of conditions

             (3)  The Minister may, by writing:

                     (a)  vary the conditions of an exemption made under section 41GS (including by imposing new conditions); or

                     (b)  revoke the conditions of an exemption made under section 41GS.

When variation or revocation takes effect

             (4)  A variation or revocation under this section takes effect:

                     (a)  if the Minister states in the variation or revocation that the variation or revocation is necessary to prevent imminent risk of death, serious illness or serious injury—on the day the variation or revocation is made; or

                     (b)  in any other case—on a later day specified in the variation or revocation (which must not be earlier than 28 days after the day the variation or revocation is made).

41GV  Informing persons of exemption etc.

                   If the Minister makes an exemption under section 41GS, the Minister must take reasonable steps to give a copy of the following to each person covered by paragraph 41GT(c):

                     (a)  the exemption;

                     (b)  any variation or revocation of the exemption under section 41GU.

41GW  Notification and tabling

Notification

             (1)  The Secretary must cause a notice setting out particulars of the following:

                     (a)  an exemption made under section 41GS because of paragraph 41GS(2)(b) or subparagraph (2A)(b)(ii);

                     (b)  a variation or revocation under section 41GU, to the extent that the variation or revocation relates to an exemption made under section 41GS because of paragraph 41GS(2)(b) or subparagraph (2A)(b)(ii);

to be published in the Gazette within 5 working days after the day on which the exemption, variation or revocation is made. However, the exemption, variation or revocation is not invalid merely because of a failure to comply with this subsection.

Tabling

             (2)  The Minister must cause a document setting out particulars of the following:

                     (a)  an exemption made under section 41GS because of paragraph 41GS(2)(b) or subparagraph (2A)(b)(ii);

                     (b)  a variation or revocation under section 41GU, to the extent that the variation or revocation relates to an exemption made under section 41GS because of paragraph 41GS(2)(b) or subparagraph (2A)(b)(ii);

to be tabled in each House of the Parliament within 5 sitting days of that House after the day on which the exemption, variation or revocation is made. However, the exemption, variation or revocation is not invalid merely because of a failure to comply with this subsection.

41GY  Disposal of unused medical devices

             (1)  This section applies to a medical device if:

                     (a)  an exemption under section 41GS in relation to that kind of medical device ceases to have effect otherwise than because that kind of medical device becomes included in the Register under Part 4‑5; and

                     (b)  the medical device has not been used before the exemption so ceases to have effect.

             (2)  The Secretary may arrange for the disposal of the medical device in accordance with the regulations.

             (3)  Regulations made for the purposes of subsection (2) may set out the methods by which the medical device is to be stored, supplied, destroyed, exported or otherwise disposed of.

             (4)  A method set out in the regulations under subsection (3) must not enable or permit any benefit to be conferred on a person (including the Commonwealth) other than the owner of the medical device.

Part 4‑7Other exemptions from including medical devices in the Register

  

41H  What this Part is about

In addition to Part 4‑6A, there are 4 other kinds of exemptions from the prohibitions in Division 3 of Part 4‑11 on dealing in medical devices that are not included in the Register:

               (a)     medical devices exempted under the regulations;

              (b)     approval for medical devices to be used for special treatment of individuals or for experimental purposes;

               (c)     authorisation of health practitioners to supply specified medical devices;

              (d)     medical devices exempted if substitutes are unavailable or in short supply.

41HA  Devices exempted from inclusion in the Register

             (1)  The regulations may exempt from the operation of Division 3 of Part 4‑11:

                     (a)  all medical devices, except those medical devices of the kinds prescribed for the purposes of this paragraph; or

                     (b)  specified kinds of medical devices.

Note:          Division 3 of Part 4‑11 contains offences and civil penalty provisions relating to dealing in medical devices that are not included in the Register.

             (2)  An exemption may be subject to conditions that are prescribed in the regulations.

Note:          Breach of the conditions may be an offence: see subsection 41MN(9).

             (3)  An exemption under paragraph (1)(a) has effect only for classes of persons prescribed in the regulations for the purposes of this subsection.

             (4)  If the regulations revoke an exemption, the revocation takes effect on the day specified. The day must not be earlier than 20 working days after the day on which the regulations are made.

41HB  Approvals for special and experimental uses

             (1)  The Secretary may grant a written approval to a person for:

                     (a)  the importation into Australia; or

                     (b)  the exportation from Australia; or

                     (c)  the supply in Australia;

of a specified medical device or kind of medical device (other than medical devices included in the Register or exempt devices):

                     (d)  for use in the treatment of another person; or

                     (e)  for use solely for experimental purposes in humans.

Note:          For variation of an approval for use of the kind referred to in paragraph (1)(e), see subsection (8).

          (1A)  An approval for use of the kind referred to in paragraph (1)(d) must not be granted to a person unless the person is a health practitioner.

             (2)  The approval may be given subject to conditions specified in the approval, including a condition relating to charging for medical devices of the kinds in question.

Note:          Breach of the conditions may be an offence: see subsection 41MN(9).

             (3)  In addition, the regulations may prescribe conditions that apply to a person’s approval to use specified kinds of medical devices solely for experimental purposes in humans. The conditions may relate to one or more of the following:

                     (a)  the preconditions on another person’s use of devices of those kinds for those purposes;

                     (b)  the principles to be followed in another person’s use of devices of those kinds for those purposes;

                     (c)  the monitoring of another person’s use, and the results of that use, of devices of those kinds for those purposes;

                     (d)  the circumstances in which that other person must cease using devices of those kinds for those purposes.

             (4)  An application to use specified medical devices in the treatment of another person must be in a form (if any) approved, in writing, by the Secretary and be accompanied by any information about the devices that is required by the Secretary.

             (5)  An application to use specified kinds of medical devices solely for experimental purposes in humans must:

                     (a)  be in a form (if any) approved, in writing, by the Secretary; and

                     (b)  be accompanied by any information about the kinds of devices that is required by the Secretary; and

                     (c)  be accompanied by the prescribed fee.

             (6)  The Secretary must:

                     (a)  consider any application under this section; and

                     (b)  assess any information submitted with the application; and

                     (c)  notify the applicant, within 20 working days of making the decision:

                              (i)  of the decision; and

                             (ii)  in the case of a decision not to grant the approval—of the reasons for the decision.

             (7)  The use by a person for experimental purposes in humans of specified kinds of medical devices that are the subject of an approval granted to someone else under paragraph (1)(e) is subject to the conditions (if any) specified in the regulations relating to one or more of the following:

                     (a)  the preconditions on the use of devices of those kinds for those purposes;

                     (b)  the principles to be followed in the use of devices of those kinds for those purposes;

                     (c)  the monitoring of the use, and the results of the use, of devices of those kinds for those purposes;

                     (d)  the circumstances in which the person must cease the use of devices of those kinds for those purposes.

Note:          Breach of the conditions may be an offence: see subsection 41MN(9).

Varying approval for use solely for experimental purposes in humans

             (8)  If:

                     (a)  the Secretary grants an approval to a person under subsection (1) for use of the kind referred to in paragraph (1)(e); and

                     (b)  the person requests the Secretary to do either or both of the following:

                              (i)  vary the medical device or kind of medical device specified in the approval;

                             (ii)  vary the conditions imposed under subsection (2) on the approval; and

                     (c)  the request is in a form (if any) approved, in writing, by the Secretary; and

                     (d)  the request is accompanied by such information relating to the medical device or kind of medical device as is required by the Secretary; and

                     (e)  the request is accompanied by the fee prescribed by the regulations;

the Secretary must, by notice in writing, vary or refuse to vary the approval. Any variation may be different than the variation requested and may involve imposing new conditions on the approval or varying or removing existing conditions.

             (9)  The Secretary must notify the person making the request under subsection (8) of:

                     (a)  the Secretary’s decision on the request; and

                     (b)  for a decision to vary the approval in a way that is different than the variation requested or a decision to refuse to vary the approval—the reasons for the decision.

           (10)  A variation under subsection (8) takes effect at the time the Secretary notifies the person under subsection (9) of the variation.

41HC  Authorities for health practitioners

             (1)  The Secretary may authorise, in writing, a specified medical practitioner to supply specified kinds of medical devices for use in the treatment of humans to a specified class of recipients.

          (1A)  An application for an authority under subsection (1) must be in a form (if any) approved, in writing, by the Secretary.

             (2)  An authority under subsection (1) may be given subject to conditions specified in the authority.

             (3)  The Secretary may impose conditions (or further conditions) on the authority given to a person under subsection (1) by giving the person written notice of the conditions.

             (4)  An authority under subsection (1) may only be given:

                     (a)  to a medical practitioner included in a class of medical practitioners prescribed by the regulations for the purposes of this paragraph; and

                     (b)  to a medical practitioner who has the approval of an ethics committee to supply the specified kinds of medical devices or the specified class of such devices; and

                     (c)  in relation to a class or classes of recipients prescribed by the regulations for the purposes of this paragraph.

However, the regulations may prescribe circumstances in which paragraph (b) does not apply.

             (5)  The regulations may prescribe circumstances in which medical devices may be supplied under an authority under subsection (1).

             (6)  The Minister may, by legislative instrument, make rules authorising any health practitioner who is included in a specified class of health practitioners to supply a specified kind of medical device, for use in the treatment of humans, to the class or classes of recipients specified in those rules, so long as:

                     (a)  that kind of medical device is supplied in the circumstances specified in those rules; and

                     (b)  the conditions (if any) specified in those rules are satisfied.

          (6A)  In making rules under subsection (6), the Minister must comply with:

                     (a)  such requirements (if any) as are prescribed by the regulations; and

                     (b)  such restrictions (if any) as are prescribed by the regulations; and

                     (c)  such limitations (if any) as are prescribed by the regulations.

          (6B)  If:

                     (a)  a person is authorised, by subsection (6) rules, to supply a specified kind of medical device; and

                     (b)  the person supplies a medical device of that kind in accordance with those rules;

the person must:

                     (c)  notify the supply to the Secretary; and

                     (d)  do so within 28 days after the supply.

          (6C)  A notification under subsection (6B) must:

                     (a)  be in accordance with a form that is approved, in writing, by the Secretary; and

                     (b)  contain such information as is prescribed by the regulations.

          (6D)  An approval of a form may require or permit information to be given in accordance with specified software requirements:

                     (a)  on a specified kind of data processing device; or

                     (b)  by way of a specified kind of electronic transmission.

          (6E)  A person commits an offence if:

                     (a)  the person is subject to a requirement under subsection (6B); and

                     (b)  the person omits to do an act; and

                     (c)  the omission breaches the requirement.

Penalty:  10 penalty units.

           (6F)  An offence against subsection (6E) is an offence of strict liability.

Note:          For strict liability, see section 6.1 of the Criminal Code.

        (6FA)  Subsection (6E) does not apply in relation to a person and a requirement to notify a supply of a medical device if a health practitioner, on behalf of the person, does the following:

                     (a)  notifies the supply to the Secretary within 28 days after the supply;

                     (b)  makes the notification in accordance with the requirements referred to in subsection (6C).

Note:          A defendant bears an evidential burden in relation to the matter in subsection (6FA): see subsection 13.3(3) of the Criminal Code.

          (6G)  In recommending to the Governor‑General that regulations should be made for the purposes of paragraph (6C)(b), the Minister must have regard to the principle that information should only be prescribed for the purposes of that paragraph if the information is reasonably required for the responsible scrutiny by the Secretary of the operation of the scheme embodied in subsection (6).

             (7)  In this section:

medical practitioner means a person who is registered, in a State or internal Territory, as a medical practitioner.

41HD  Approvals if substitutes for medical devices are unavailable or in short supply

             (1)  The Secretary may, by notice in writing, grant an approval to a person for:

                     (a)  the importation into Australia of a specified medical device; or

                     (b)  the importation into Australia of a specified medical device and the supply in Australia of that device;

if the Secretary is satisfied that:

                     (c)  the kinds of medical devices included in the Register that could act as a substitute for the medical device are unavailable or are in short supply; and

                     (d)  either:

                              (i)  the medical device is registered or approved for general marketing in at least one foreign country specified in a determination under subsection (5); or

                             (ii)  an application has been made in accordance with section 41FC for inclusion in the Register of the kind of medical device that includes the medical device and the application has passed preliminary assessment; and

                     (e)  the medical device is specified in a determination under subsection (6); and

                      (f)  the approval is necessary in the interests of public health.

Note:          For specification by class, see the Acts Interpretation Act 1901 and subsection 13(3) of the Legislation Act 2003.

          (1A)  The Secretary may, by notice in writing, grant an approval to a person for:

                     (a)  the importation into Australia of a specified medical device; or

                     (b)  the importation into Australia of a specified medical device and the supply in Australia of that device;

if the Secretary is satisfied that:

                     (c)  the kinds of medical devices included in the Register that could act as a substitute for the medical device are unavailable or are in short supply; and

                     (d)  either:

                              (i)  the medical device is not registered or approved for general marketing in any of the foreign countries specified in a determination under subsection (5); or

                             (ii)  the medical device is registered or approved for general marketing in at least one foreign country specified in a determination under subsection (5), but is not readily available for importation into, and supply in, Australia; and

                     (e)  the medical device is registered or approved for general marketing in a foreign country; and

                      (f)  the manufacturing and quality control procedures used in the manufacture of the medical device are acceptable; and

                     (g)  the medical device is specified in a determination under subsection (6); and

                     (h)  the approval is necessary in the interests of public health.

Note:          For specification by class, see the Acts Interpretation Act 1901 and subsection 13(3) of the Legislation Act 2003.

             (2)  The Secretary may, by notice in writing, grant an approval to a person for:

                     (a)  the importation into Australia of a specified medical device; or

                     (b)  the importation into Australia of a specified medical device and the supply in Australia of that device;

if the Secretary is satisfied that:

                     (c)  there are no kinds of medical devices that are included in the Register that could act as a substitute for the medical device; and

                     (d)  an application has been made in accordance with section 41FC for inclusion in the Register of the kind of medical device that includes the medical device and the application has passed preliminary assessment; and

                     (e)  the medical device is specified in a determination under subsection (6); and

                      (f)  the approval is necessary in the interests of public health.

Note:          For specification by class, see the Acts Interpretation Act 1901 and subsection 13(3) of the Legislation Act 2003.

Application for approval

             (3)  An application for an approval must:

                     (a)  be made to the Secretary; and

                     (b)  be accompanied by such information relating to the medical device as is required by the Secretary.

Notification of Secretary’s decision

             (4)  If an application for an approval is made, the Secretary must, as soon as practicable after deciding the application, notify the applicant of:

                     (a)  the decision; and

                     (b)  if the decision is not to grant the approval—the reasons for the decision.

Determinations

             (5)  The Secretary may, by legislative instrument, make a determination specifying foreign countries for the purposes of subparagraph (1)(d)(i).

             (6)  The Secretary may, by legislative instrument, make a determination specifying medical devices that can be the subject of an approval under this section.

Conditions

             (7)  The Secretary may grant an approval subject to any conditions that are specified in the notice of approval.

Note:          Breach of the conditions may be an offence: see subsection 41MN(9).

Period of approval

             (8)  The Secretary may grant an approval for such period as is specified in the notice of approval.

When approval lapses

             (9)  The approval lapses if:

                     (a)  the period specified in the notice of approval expires; or

                     (b)  a decision has been made on an application that has been made for inclusion in the Register of the kind of medical device that includes the medical device.

           (10)  The approval lapses if:

                     (a)  the Secretary is satisfied that paragraph (1)(c), (d), (e) or (f), paragraph (1A)(c), (d), (e), (f), (g) or (h), or paragraph (2)(c), (d), (e) or (f), as the case requires, no longer applies in relation to the medical device, or that a condition of the approval has been contravened; and

                     (b)  the Secretary has given to the person to whom the approval was granted a notice stating that the Secretary is so satisfied.

           (11)  The lapsing of the approval on the expiry of the period specified in the notice of approval does not prevent another approval being granted under this section in relation to the medical device before that lapsing. The other approval may be expressed to take effect on the expiry of that period.

Approval not a legislative instrument

           (12)  An approval under subsection (1), (1A) or (2) is not a legislative instrument.

Part 4‑8Obtaining information

  

41J  What this Part is about

The Secretary may seek information or documents relating to:

•      the application of conformity assessment procedures or requirements comparable to those procedures;

•      compliance with the essential principles;

•      compliance with other requirements;

•      distribution of, and other matters relating to, medical devices covered by exemptions under Part 4‑6A or Part 4‑7.

Note:          There are additional obligations relating to notifying defects in medical devices: see sections 41MP, 41MPA, 41MQ and 41MR.

Division 1Information relating to compliance with requirements and other matters

41JA  Secretary may require information or documents

             (1)  The Secretary may, by written notice given to a person:

                     (a)  who is an applicant for a conformity assessment certificate that would relate to a kind of medical device; or

                     (b)  who holds a conformity assessment certificate, or an Australian conformity assessment body certificate, that relates to a kind of medical device; or

                   (ba)  who held, at any time during the notice period under subsection (2), a conformity assessment certificate, or an Australian conformity assessment body certificate, that related to a kind of medical device; or

                     (c)  who is an applicant for the inclusion of a kind of medical device in the Register; or

                     (d)  in relation to whom a kind of medical device is included in the Register; or

                   (da)  in relation to whom a kind of medical device was, at any time during the notice period under subsection (2), included in the Register;

require the person to give to the Secretary information or documents, relating to devices of that kind, that are relevant to one or more of the following:

                     (e)  whether the devices comply with the essential principles;

                      (f)  whether the conformity assessment procedures have been applied to the devices or whether requirements, comparable to those procedures, have been applied to the devices;

                     (g)  whether the devices comply with conditions (if any) imposed on a conformity assessment certificate issued in respect of the device or the inclusion of the device in the Register;

                     (h)  whether either of the following has not been complied with in relation to the devices:

                              (i)  an applicable provision of the Therapeutic Goods Advertising Code;

                             (ii)  any other requirement relating to advertising applicable under Part 5‑1 or under the regulations;

                      (i)  if the kind of medical device is included in the Register in relation to the person—whether medical devices of that kind are being:

                              (i)  supplied in Australia; or

                             (ii)  imported into Australia; or

                            (iii)  exported from Australia;

                   (iaa)  if the kind of medical device is included in the Register in relation to the person and there are one or more absolute prohibitions in force for the purposes of subsection 9K(1) or (3)—whether any supplies in Australia, any imports into Australia, any exports from Australia or any manufacture in Australia of medical devices of that kind contravene those prohibitions;

                  (iab)  if the kind of medical device is included in the Register in relation to the person and there are one or more prohibitions in force for the purposes of subsection 9K(1) or (3) that are subject to conditions—whether any supplies in Australia, any imports into Australia, any exports from Australia or any manufacture in Australia of medical devices of that kind contravene those conditions;

                    (ia)  the safety and efficacy of the devices for the purposes for which they are to be used;

                    (ib)  the regulatory history of the devices in another country;

                      (j)  any other matter prescribed by the regulations for the purposes of this paragraph.

       (1AA)  If a notice is given under subsection (1) to a person covered by paragraph (1)(ba), then paragraphs (1)(e) to (j) (to the extent to which they are relevant) apply in relation to the period the person held the certificate.

       (1AB)  If a notice is given under subsection (1) to a person covered by paragraph (1)(da), then paragraphs (1)(e) to (j) (to the extent to which they are relevant) apply in relation to the period the kind of medical device was included in the Register.

          (1A)  The Secretary may, by written notice given to a person who is an applicant for a conformity assessment certificate, require the person to give to the Secretary such further information concerning the application as is specified in the notice.

          (1B)  Requirements under subsections (1) and (1A) may be included in the same notice.

          (1C)  The Secretary may, by written notice given to a person who holds a conformity assessment certificate, require the person to give to the Secretary specified information to be used by the Secretary in deciding whether to suspend the certificate under section 41EM, or to revoke the certificate under section 41ET, in relation to the circumstances referred to in paragraph 41ET(1)(e).

          (1D)  Requirements under subsections (1) and (1C) may be included in the same notice.

          (1E)  The Secretary may, by written notice given to an Australian corporation that has been an Australian conformity assessment body require the corporation to give to the Secretary specified information, or specified documents, relating to:

                     (a)  the certification‑related activities carried on by the corporation while the corporation was an Australian conformity assessment body; or

                     (b)  the conditions referred to in subsection 41EWA(5) that applied while the corporation was an Australian conformity assessment body.

             (2)  For the purposes of paragraphs (1)(ba) and (da), the notice period is the period:

                     (a)  of the length specified in the regulations; and

                     (b)  ending on the day before the Secretary gives the notice under subsection (1).

             (3)  Nothing in this section affects the operation of Part VIIC of the Crimes Act 1914 (which includes provisions that, in certain circumstances, relieve persons from the requirement to disclose spent convictions and require persons aware of such convictions to disregard them).

41JB  Complying with the Secretary’s requirements

             (1)  The person must give the information or documents to the Secretary:

                     (a)  within such reasonable time, being not less than 10 working days from the day on which the notice is given, as is specified in the notice; and

                     (b)  in such form as is specified in the notice.

             (2)  The form may require or permit information to be given in accordance with specified software requirements:

                     (a)  on a specified kind of data processing device; or

                     (b)  by way of a specified kind of electronic transmission.

Offence for failing to comply with a notice

             (3)  A person commits an offence if:

                     (a)  the person is given a notice under section 41JA; and

                    (aa)  the person is covered by paragraph 41JA(1)(b), (ba), (d) or (da) or subsection 41JA(1E); and

                     (b)  the person fails to comply with the notice.

Penalty:  500 penalty units.

Note:          Failure to comply with the notice might also lead to suspension or revocation of a conformity assessment certificate (see Divisions 3 and 4 of Part 4‑4) or suspension or cancellation of the entry of a kind of medical device in the Register (see Part 4‑6).

          (3A)  Subsection (3) does not apply if the person has a reasonable excuse.

Note:          A defendant bears an evidential burden in relation to the matter in subsection (3A): see subsection 13.3(3) of the Criminal Code.

          (3B)  A person commits an offence if:

                     (a)  the person is given a notice under section 41JA; and

                     (b)  the person is covered by paragraph 41JA(1)(b), (ba), (d) or (da) or subsection 41JA(1E); and

                     (d)  the person fails to comply with the notice.

Penalty:  100 penalty units.

          (3C)  An offence against subsection (3B) is an offence of strict liability.

          (3D)  Subsection (3B) does not apply if the person has a reasonable excuse.

Note:          A defendant bears an evidential burden in relation to the matter in subsection (3D): see subsection 13.3(3) of the Criminal Code.

Offences for giving false or misleading information in purported compliance with a notice

             (4)  A person commits an offence if:

                     (a)  the person is given a notice under section 41JA in relation to a kind of medical device; and

                     (b)  the person gives information in purported compliance with the notice; and

                     (c)  the information is false or misleading in a material particular; and

                     (d)  either:

                              (i)  the use of the kind of medical device has resulted in, will result in, or is likely to result in, harm or injury to any person; or

                             (ii)  the use of the kind of medical device, if the kind of medical device were used, would result in, or would be likely to result in, harm or injury to any person.

Penalty:  Imprisonment for 5 years or 4,000 penalty units, or both.

Note 1:       A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (7) instead: see section 53A.

Note 2:       For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

             (7)  A person commits an offence if:

                     (a)  the person is given a notice under section 41JA; and

                     (b)  the person gives information in purported compliance with the notice; and

                     (c)  the information is false or misleading in a material particular.

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.

             (8)  A person commits an offence if:

                     (a)  the person is given a notice under section 41JA; and

                     (b)  the person gives information in purported compliance with the notice; and

                     (c)  the information is false or misleading in a material particular.

Penalty:  100 penalty units.

             (9)  An offence against subsection (8) is an offence of strict liability.

41JBA  Civil penalty for giving false or misleading information in purported compliance with a notice

                   A person contravenes this section if:

                     (a)  the person is given a notice under section 41JA; and

                     (b)  the person gives information in purported compliance with the notice; and

                     (c)  the information is false or misleading in a material particular.

Maximum civil penalty:

                     (a)  for an individual—5,000 penalty units; and

                     (b)  for a body corporate—50,000 penalty units.

41JC  Self‑incrimination

             (1)  A person is not excused from giving information or a document under section 41JB on the ground that to do so would tend to incriminate the person or expose the person to a penalty.

             (2)  However, in the case of an individual:

                     (a)  the information given; or

                     (b)  the giving of the document; or

                     (c)  any information, document or thing obtained as a direct or indirect consequence of giving the information or document;

is not admissible in evidence in:

                     (d)  criminal proceedings against the individual, except proceedings under, or arising out of, subsection 41JB(4), (7) or (8); or

                     (e)  proceedings for a pecuniary penalty order against the individual for a contravention of a civil penalty provision, except civil proceedings under, or arising out of, section 41JBA.

Division 2Information relating to medical devices covered by exemptions

41JCA  Secretary may require information etc. about medical devices exempt under Part 4‑6A

             (1)  This section applies to a person who is required to comply with a condition of an exemption of a kind of medical device under section 41GS.

             (2)  The Secretary may, by written notice given to the person, require the person to give to the Secretary specified information or documents relating to one or more of the following:

                     (a)  the supply of devices of that kind;

                     (b)  the handling of devices of that kind;

                     (c)  the monitoring of the supply of devices of that kind;

                     (d)  the results of the supply of devices of that kind;

                     (e)  any other matter prescribed by the regulations for the purposes of this paragraph in relation to devices of that kind.

             (3)  The notice must specify a reasonable period within which the person to whom the notice is given must comply. The period must be at least 10 working days starting on the day on which the notice is given.

             (4)  The notice may require information to be given in accordance with specified software requirements:

                     (a)  on a specified kind of data processing device; or

                     (b)  by way of a specified kind of electronic transmission.

41JD  Secretary may require information etc. about devices exempted under section 41HA from inclusion in the Register

             (1)  The Secretary may give the sponsor of kinds of medical devices exempted under subsection 41HA(1) from Division 3 of Part 4‑11, a written notice requiring the sponsor to give to the Secretary specified information or documents relating to one or more of the following:

                     (a)  the supply of devices of those kinds;

                     (b)  the handling of devices of those kinds;

                     (c)  the monitoring of the supply of devices of those kinds;

                     (d)  the results of the supply of devices of those kinds;

                     (e)  any other matter prescribed by the regulations for the purposes of this paragraph in relation to devices of those kinds.

             (2)  If a medical device is exempt under subsection 41HA(1) because a medical practitioner has signed a statement in accordance with regulations made for the purposes of this section, the Secretary may give the medical practitioner a written notice requiring the medical practitioner to give to the Secretary specified information or documents relating to one or more of the following:

                     (a)  the condition of the person to whom the medical device is to be given or is given;

                     (b)  the supply of the device;

                     (c)  the handling of the device;

                     (d)  the monitoring of the supply of the device;

                     (e)  the results of the supply of the device;

                      (f)  any other matter prescribed by the regulations for the purposes of this paragraph in relation to medical devices of that kind.

             (3)  A notice under this section must specify a reasonable period within which the person must comply. The period must be at least 10 working days starting on the day on which the notice is given.

             (4)  A notice under this section may require information to be given in accordance with specified software requirements:

                     (a)  on a specified kind of data processing device; or

                     (b)  by way of a specified kind of electronic transmission.

41JE  Secretary may require information relating to approvals under section 41HB

Approval under subsection 41HB(1)

             (1)  The Secretary may give to a person granted an approval under subsection 41HB(1) (special and experimental uses), in relation to specified kinds of medical devices, a written notice requiring the person to give to the Secretary specified information or documents relating to one or more of the following:

                     (a)  the supply of devices of those kinds;

                     (b)  the handling of devices of those kinds;

                     (c)  the monitoring of the supply of devices of those kinds;

                     (d)  the results of the supply of devices of those kinds;

                     (e)  any other matter prescribed by the regulations for the purposes of this paragraph in relation to devices of those kinds.

Approval under subsection 41HB(1)—use by another person

             (2)  The Secretary may give to a person using specified kinds of medical devices, that are the subject of an approval granted to someone else under paragraph 41HB(1)(e) (use solely for experimental purposes in humans), a written notice requiring the person to give to the Secretary specified information or documents relating to either of both of the following:

                     (a)  the use of devices of those kinds;

                     (b)  any other matter prescribed by the regulations for the purposes of this paragraph in relation to devices of those kinds.

Compliance period

             (3)  A notice under this section must specify a reasonable period within which the person to whom the notice is given must comply. The period must be at least 10 working days starting on the day on which the notice is given.

Information may need to be given in accordance with specified software requirements

             (4)  A notice under this section may require information to be given in accordance with specified software requirements:

                     (a)  on a specified kind of data processing device; or

                     (b)  by way of a specified kind of electronic transmission.

41JF  Secretary may require information relating to health practitioner authorisations

             (1)  The Secretary may give to a person who is granted an authority under subsection 41HC(1) (exemptions for medical practitioners), in relation to specified kinds of medical devices, a written notice requiring the person to give to the Secretary specified information or documents relating to one or more of the following:

                     (a)  the supply of devices of those kinds;

                     (b)  the handling of devices of those kinds;

                     (c)  the monitoring of the supply of devices of those kinds;

                     (d)  the results of the supply of devices of those kinds;

                     (e)  any other matter prescribed by the regulations for the purposes of this paragraph in relation to devices of those kinds.

          (1A)  If a person is authorised, by subsection 41HC(6) rules, to supply a specified kind of medical device, the Secretary may give the person a written notice requiring the person to give the Secretary specified information or documents relating to one or more of the following:

                     (a)  the supply of devices of that kind;

                     (b)  the handling of devices of that kind;

                     (c)  the monitoring of the supply of devices of that kind;

                     (d)  the results of the supply of devices of that kind;

                     (e)  any other matter prescribed by the regulations for the purposes of this paragraph in relation to devices of that kind.

             (2)  A notice under subsection (1) or (1A) must specify a reasonable period within which the person to whom the notice is given must comply. The period must be at least 10 working days starting on the day on which the notice is given.

             (3)  A notice under subsection (1) or (1A) may require information to be given in accordance with specified software requirements:

                     (a)  on a specified kind of data processing device; or

                     (b)  by way of a specified kind of electronic transmission.

41JFA  Secretary may require information relating to approvals under section 41HD

             (1)  The Secretary may give to a person who is granted an approval under subsection 41HD(1), (1A) or (2) in relation to a medical device a written notice requiring the person to give to the Secretary specified information or documents relating to one or more of the following:

                     (a)  the supply of the medical device;

                     (b)  the handling of the medical device;

                     (c)  the monitoring of the supply of the medical device;

                     (d)  the results of the supply of the medical device;

                     (e)  any other matter prescribed by the regulations for the purposes of this paragraph in relation to the kind of medical device that includes the medical device.

             (2)  The notice must specify a reasonable period within which the person must comply. The period must be at least 10 working days starting on the day on which the notice is given.

             (3)  The notice may require information to be given in accordance with specified software requirements:

                     (a)  on a specified kind of data processing device; or

                     (b)  by way of a specified kind of electronic transmission.

41JG  Criminal offences for failing to give information or documents sought under this Division

             (1)  A person commits an offence if:

                     (a)  the person is given a notice under section 41JCA, 41JD, 41JE, 41JF or 41JFA; and

                     (b)  the person fails to comply with the notice.

Penalty:  400 penalty units.

             (2)  A person commits an offence if:

                     (a)  the person is given a notice under section 41JCA, 41JD, 41JE, 41JF or 41JFA; and

                     (b)  the person fails to comply with the notice.

Penalty:  100 penalty units.

             (3)  An offence against subsection (2) is an offence of strict liability.

41JH  False or misleading information

             (1)  A person to whom a notice is given under section 41JCA, 41JD, 41JE, 41JF or 41JFA commits an offence if:

                     (a)  the person gives information to the Secretary; and

                     (b)  the person knows that the information:

                              (i)  is false or misleading; or

                             (ii)  omits any matter or thing without which the information is misleading; and

                     (c)  the information is given in compliance or purported compliance with the notice.

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.

Note:          For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

             (2)  A person to whom a notice is given under section 41JCA, 41JD, 41JE, 41JF or 41JFA commits an offence if:

                     (a)  the person gives information to the Secretary; and

                     (b)  the information:

                              (i)  is false or misleading; or

                             (ii)  omits any matter or thing without which the information is misleading; and

                     (c)  the information is given in compliance or purported compliance with the notice.

Penalty:  100 penalty units.

             (3)  An offence against subsection (2) is an offence of strict liability.

             (4)  Subsection (1) or (2) does not apply as a result of subparagraph (1)(b)(i) or (2)(b)(i) if the information is not false or misleading in a material particular.

Note:          A defendant bears an evidential burden in relation to the matter in subsection (4): see subsection 13.3(3) of the Criminal Code.

             (5)  Subsection (1) or (2) does not apply as a result of subparagraph (1)(b)(ii) or (2)(b)(ii) if the information did not omit any matter or thing without which the information is misleading in a material particular.

Note:          A defendant bears an evidential burden in relation to the matter in subsection (5): see subsection 13.3(3) of the Criminal Code.

41JI  False or misleading documents

             (1)  A person commits an offence if:

                     (a)  the person produces a document to the Secretary; and

                     (b)  the person knows that the document is false or misleading; and

                     (c)  the document is produced in compliance or purported compliance with a notice given under section 41JCA, 41JD, 41JE, 41JF or 41JFA.

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.

Note:          For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

          (1A)  A person commits an offence if:

                     (a)  the person produces a document to the Secretary; and

                     (b)  the document is false or misleading; and

                     (c)  the document is produced in compliance or purported compliance with a notice given under section 41JCA, 41JD, 41JE, 41JF or 41JFA.

Penalty:  100 penalty units.

          (1B)  An offence against subsection (1A) is an offence of strict liability.

          (1C)  Subsection (1) or (1A) does not apply if the document is not false or misleading in a material particular.

Note:          A defendant bears an evidential burden in relation to the matter in subsection (1C): see subsection 13.3(3) of the Criminal Code.

             (2)  Subsection (1) or (1A) does not apply to a person who produces a document if the document is accompanied by a written statement signed by the person or, in the case of a body corporate, by a competent officer of the body corporate:

                     (a)  stating that the document is, to the knowledge of the first‑mentioned person, false or misleading in a material particular; and

                     (b)  setting out, or referring to, the material particular in which the document is, to the knowledge of the first‑mentioned person, false or misleading.

Note:          A defendant bears an evidential burden in relation to the matter in subsection (2) (see subsection 13.3(3) of the Criminal Code).

41JJ  Self‑incrimination

             (1)  A person is not excused from giving information or a document under a notice given under section 41JCA, 41JD, 41JE, 41JF or 41JFA on the ground that to do so would tend to incriminate the person or expose the person to a penalty.

             (2)  However, in the case of an individual:

                     (a)  the information given; or

                     (b)  the giving of the document; or

                     (c)  any information, document or thing obtained as a direct or indirect consequence of giving the information or document;

is not admissible in evidence in:

                     (d)  criminal proceedings against the individual, except proceedings under, or arising out of, section 41JH or 41JI; or

                     (e)  proceedings for a pecuniary penalty order against the individual for a contravention of a civil penalty provision.

Part 4‑9Public notification, and recall, of medical devices

  

41K  What this Part is about

The Secretary can require action to recall medical devices, or to inform the public about medical devices, that do not comply with requirements or cannot lawfully be supplied.

41KA  Public notification, and recall, of medical devices

             (1)  The Secretary may, in writing, impose requirements, relating to a kind of medical device, on a person if:

                     (a)  any of the circumstances referred to in the second column of an item in the following table occur in relation to the kind of device; and

                     (b)  the person is referred to in the third column of that item of the table.

 

Circumstances in which requirements may be imposed

Item

Circumstance relating to a kind of medical device

Person subject to requirements

1.

It is supplied while it is included in the Register, but the Secretary is satisfied that medical devices of that kind do not comply with the essential principles

The person in relation to whom it is included in the Register

2.

It is supplied while it is included in the Register, but the Secretary is satisfied that the conformity assessment procedures have not been applied to medical devices of that kind and that requirements, comparable to those procedures, have not been applied to medical devices of that kind

The person in relation to whom it is included in the Register

3.

It is supplied while:

(a) medical devices of that kind are exempt devices; or

(b) there is an approval under section 41HB relating to devices of that kind; or

(c) there is an authority under section 41HC relating to devices of that kind; or

(d) there is an approval under subsection 41HD(1), (1A) or (2) relating to devices of that kind;

but the Secretary is satisfied that medical devices of that kind do not comply with the essential principles

The person supplying the kind of medical device

4.

It is supplied while:

(a) medical devices of that kind are exempt devices; or

(b) there is an approval under section 41HB relating to devices of that kind; or

(c) there is an authority under section 41HC relating to devices of that kind; or

(d) there is an approval under subsection 41HD(1), (1A) or (2) relating to devices of that kind;

but the Secretary is satisfied that the conformity assessment procedures have not been applied to medical devices of that kind and that requirements, comparable to those procedures, have not been applied to medical devices of that kind

The person supplying the kind of medical device

4A.

It is supplied and the Secretary is satisfied that:

(a) if there are one or more absolute prohibitions in force for the purposes of subsection 9K(1) or (3)—the supply contravenes one or more of those prohibitions; or

(b) if there are one or more prohibitions in force for the purposes of subsection 9K(1) or (3) that are subject to conditions—the supply contravenes one or more of those conditions

The person supplying the kind of medical device

5.

It is supplied while:

(a) it is not included in the Register; and

(aa) it is not covered by an exemption in force under section 41GS; and

(b) it is not an exempt device; and

(c) there is not an approval under section 41HB relating to devices of that kind; and

(d) there is not an authority under section 41HC relating to devices of that kind; and

(e) there is not an approval under subsection 41HD(1), (1A) or (2) relating to devices of that kind.

The person supplying the kind of medical device

5A.

It is supplied while it is covered by an exemption in force under section 41GS, and the Secretary is satisfied that it is not fit to be used for its intended purpose

The person supplying the kind of medical device

5B.

It is supplied while it is included in the Register, but it appears to the Secretary that the quality, safety or performance of medical devices of that kind is unacceptable

The person in relation to whom the kind of medical device is included in the Register

6.

It has been suspended from the Register

The person in relation to whom it was included in the Register

7.

Its entry has been cancelled from the Register

The person in relation to whom it was included in the Register

8.

It is counterfeit goods (within the meaning of section 42E)

The person supplying the kind of medical device

             (2)  The requirements may be one or more of the following:

                     (a)  to take specified steps, in the specified manner and within such reasonable period as is specified, to recall medical devices of that kind that have been distributed;

                     (b)  to inform the public or a specified class of persons, in the specified manner and within such reasonable period as is specified, to the effect that the circumstances referred to in paragraph (1)(a) have occurred in relation to medical devices of that kind;

                     (c)  to inform the public or a specified class of persons, in the specified manner and within such reasonable period as is specified, of specified information, or of information of a specified kind, relating to either or both of the following:

                              (i)  medical devices of that kind;

                             (ii)  the circumstances referred to in paragraph (1)(a);

                     (d)  to publish, in the specified manner and within such reasonable period as is specified, specified information, or information of a specified kind, relating to the manufacture or distribution of medical devices of that kind;

                     (e)  to notify the Secretary, in the specified manner and within such reasonable period as is specified, of specified information, or of information of a specified kind, relating to the persons to whom medical devices of that kind have been supplied.

             (3)  If the circumstances referred to in paragraph (1)(a) apply only to some medical devices of that kind, the Secretary may limit the imposition of the requirements to the medical devices of that kind to which those circumstances apply.

             (4)  A requirement to recall medical devices under this section does not apply to a medical device that cannot be recalled because it has been administered to, or applied in the treatment of, a person.

41KB  Publication of requirements

                   The Secretary must cause to be published in the Gazette or on the Department’s website, as soon as practicable after imposing a requirement under section 41KA, a notice setting out particulars of the requirement.

41KC  Criminal offences for failing to comply with requirements relating to a kind of medical device

             (1)  A person commits an offence if:

                     (a)  the person does an act or omits to do an act; and

                     (b)  the act or omission breaches a requirement imposed on the person under section 41KA; and

                     (c)  the act or omission has resulted in, will result in, or is likely to result in, harm or injury to any person.

Penalty:  Imprisonment for 5 years or 4,000 penalty units, or both.

Note 1:       A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A.

Note 2:       For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

             (4)  A person commits an offence if:

                     (a)  the person does an act or omits to do an act; and

                     (b)  the act or omission breaches a requirement imposed on the person under section 41KA.

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.

             (5)  A person commits an offence if:

                     (a)  the person does an act or omits to do an act; and

                     (b)  the act or omission breaches a requirement imposed on the person under section 41KA.

Penalty:  100 penalty units.

             (6)  An offence against subsection (5) is an offence of strict liability.

41KCA  Civil penalty for failing to comply with requirements relating to a kind of medical device

                   A person contravenes this section if:

                     (a)  the person does an act or omits to do an act; and

                     (b)  the act or omission contravenes a requirement imposed on the person under section 41KA.

Maximum civil penalty:

                     (a)  for an individual—5,000 penalty units; and

                     (b)  for a body corporate—50,000 penalty units.

41KD  Powers of suspension and cancellation unaffected

                   Imposition of a requirement under section 41KA does not affect the Secretary’s powers to:

                     (a)  suspend the entry of a kind of medical device, or some medical devices of a particular kind, from the Register under Part 4‑6; or

                     (b)  cancel the entry of a kind of medical device, or some medical devices of a particular kind, in the Register under Part 4‑6.

41KE  Saving of other laws

                   This Part is not intended to exclude or limit the operation of any other law of the Commonwealth or any law of a State or Territory.

Part 4‑10Assessment fees

  

41L  What this Part is about

Conformity assessment fees must be paid for consideration of applications for conformity assessment certificates. Application audit assessment fees must be paid for auditing applications that are required to be selected for auditing under paragraph 41FH(1)(a).

41LA  Assessment fees

             (1)  A conformity assessment fee specified in or determined in accordance with the regulations is payable by a person in respect of consideration of an application for a conformity assessment certificate under Part 4‑4.

             (2)  The regulations may prescribe different levels of conformity assessment fees in relation to any one or more of the following:

                     (a)  different kinds of manufacturers;

                     (b)  different kinds of medical devices;

                     (c)  different parts of the conformity assessment procedures that are considered in relation to an application for a conformity assessment certificate under Part 4‑4.

             (3)  An application audit assessment fee specified in or determined in accordance with the regulations is payable by a person in respect of the auditing of an application for inclusion of a kind of medical device in the Register under Part 4‑5, if paragraph 41FH(1)(a) required the Secretary to select the application for audit.

             (4)  The regulations may prescribe different levels of application audit assessment fees in relation to any one or more of the following:

                     (a)  different kinds of manufacturers;

                     (b)  different kinds of medical devices;

                     (c)  different levels of assessment of kinds of medical devices.

             (5)  The application audit assessment fee payable because of subsection (3) is payable only in respect of considering the matters set out in subsection 41FI(1).

41LB  When assessment fee due for payment

                   Subject to sections 41LC and 41LE, an assessment fee payable by an applicant is due and payable on the day, and in the manner, specified in the regulations.

41LC  Payment of assessment fee by instalments

             (1)  The regulations may provide for the payment of an assessment fee to be made by such instalments and at such times as are ascertained in accordance with the regulations, and the assessment fee is due and payable accordingly.

             (2)  Regulations made for the purposes of subsection (1) may provide that a person is not allowed to pay an assessment fee by instalments if any part of an instalment of:

                     (a)  that or any other assessment fee payable by the person; or

                     (b)  any evaluation fee under section 24 payable by the person;

was unpaid immediately after the time when it became due for payment.

             (3)  Subsection (2) does not limit the generality of subsection (1).

41LD  Recovery of assessment fee

                   An assessment fee may be recovered by the Commonwealth as a debt due to the Commonwealth.

41LE  Reduction of conformity assessment fee where decision not made within prescribed period

             (1)  Nothing in section 41LA, 41LB or 41LC requires the applicant to pay more than 3/4 of the conformity assessment fee before the making of the decision if:

                     (a)  the application is for the issuing of a conformity assessment certificate under Part 4‑4; and

                     (b)  consideration of the application will involve an examination of the design of medical devices; and

                     (c)  a period is prescribed under paragraph 63(2)(dc) for making a decision on the application.

             (2)  If the decision is not made within that period, the conformity assessment fee is 3/4 of the fee that, apart from this subsection, would have been the conformity assessment fee.

             (3)  If:

                     (a)  the decision is made within that period; and

                     (b)  part of the conformity assessment fee under section 41LA is, because of subsection (1) of this section, unpaid when the decision is made;

that part becomes due and payable on the making of the decision.

             (4)  For the purposes of this section, a decision is taken to be made on the application when the applicant is notified under subsection 41EE(1) of the Secretary’s decision on the application.

Part 4‑11Offences and civil penalty provisions relating to medical devices

  

41M  What this Part is about

This Part contains offences and civil penalty provisions that are aimed at ensuring that:

•      the essential principles are complied with (see Division 1);

•      the conformity assessment procedures have been applied to kinds of medical devices or requirements, comparable to those procedures, have been applied to kinds of medical devices (see Division 2);

•      administrative processes put in place by Parts 4‑4 to 4‑9 are followed (see Divisions 3, 3A and 4).

Note:          There are also some offences and civil penalty provisions in the earlier Parts of this Chapter. They generally relate to matters ancillary to administrative processes in those Parts (e.g. false or misleading statements in applications).

Division 1Non‑compliance with essential principles

41MA  Criminal offences for importing, supplying or exporting a medical device that does not comply with essential principles

Offences relating to importing a medical device

             (1)  A person commits an offence if:

                     (a)  the person imports a medical device into Australia; and

                     (b)  the medical device does not comply with the essential principles relating to matters other than the labelling of the device; and

                     (c)  the Secretary has not consented to the importation; and

                    (ca)  the device is not of a kind covered by an exemption in force under section 41GS; and

                     (d)  either:

                              (i)  the use of the device has resulted in, will result in, or is likely to result in, harm or injury to any person; or

                             (ii)  the use of the device, if the device were used, would result in, or would be likely to result in, harm or injury to any person; and

                     (e)  the harm or injury has resulted, will result, is likely to result, would result, or would be likely to result, because the device does not comply with the essential principles.

Penalty:  Imprisonment for 5 years or 4,000 penalty units, or both.

Note 1:       A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A.

Note 2:       For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

             (4)  A person commits an offence if:

                     (a)  the person imports a medical device into Australia; and

                     (b)  the medical device does not comply with the essential principles relating to matters other than the labelling of the device; and

                     (c)  the Secretary has not consented to the importation; and

                     (d)  the device is not of a kind covered by an exemption in force under section 41GS.

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.

          (4A)  A person commits an offence if:

                     (a)  the person imports a medical device into Australia; and

                     (b)  the medical device does not comply with the essential principles relating to matters other than the labelling of the device; and

                     (c)  the Secretary has not consented to the importation; and

                     (d)  the device is not of a kind covered by an exemption in force under section 41GS.

Penalty:  100 penalty units.

          (4B)  An offence against subsection (4A) is an offence of strict liability.

Offences relating to supplying a medical device

             (5)  A person commits an offence if:

                     (a)  the person supplies a medical device for use in Australia; and

                     (b)  the medical device does not comply with the essential principles; and

                     (c)  the Secretary has not consented to the supply; and

                    (ca)  the device is not of a kind covered by an exemption in force under section 41GS; and

                     (d)  either:

                              (i)  the use of the device has resulted in, will result in, or is likely to result in, harm or injury to any person; or

                             (ii)  the use of the device, if device were used, would result in, or would be likely to result in, harm or injury to any person; and

                     (e)  the harm or injury has resulted, will result, is likely to result, would result, or would be likely to result, because the device does not comply with the essential principles.

Penalty:  Imprisonment for 5 years or 4,000 penalty units, or both.

Note 1:       A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (8) instead: see section 53A.

Note 2:       For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

             (8)  A person commits an offence if:

                     (a)  the person supplies a medical device for use in Australia; and

                     (b)  the medical device does not comply with the essential principles; and

                     (c)  the Secretary has not consented to the supply; and

                     (d)  the device is not of a kind covered by an exemption in force under section 41GS.

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.

          (8A)  A person commits an offence if:

                     (a)  the person supplies a medical device for use in Australia; and

                     (b)  the medical device does not comply with the essential principles; and

                     (c)  the Secretary has not consented to the supply; and

                     (d)  the device is not of a kind covered by an exemption in force under section 41GS.

Penalty:  100 penalty units.

          (8B)  An offence against subsection (8A) is an offence of strict liability.

Offences relating to exporting a medical device

             (9)  A person commits an offence if:

                     (a)  the person exports a medical device from Australia; and

                     (b)  the medical device does not comply with the essential principles relating to matters other than the labelling of the device for supply in Australia; and

                     (c)  the Secretary has not consented to the exportation; and

                    (ca)  the device is not of a kind covered by an exemption in force under section 41GS; and

                     (d)  either:

                              (i)  the use of the device has resulted in, will result in, or is likely to result in, harm or injury to any person; or

                             (ii)  the use of the device, if the device were used, would result in, or would be likely to result in, harm or injury to any person; and

                     (e)  the harm or injury has resulted, will result, is likely to result, would result, or would be likely to result, because the device does not comply with the essential principles.

Penalty:  Imprisonment for 5 years or 4,000 penalty units, or both.

Note 1:       A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (12) instead: see section 53A.

Note 2:       For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

           (12)  A person commits an offence if:

                     (a)  the person exports a medical device from Australia; and

                     (b)  the medical device does not comply with the essential principles relating to matters other than the labelling of the device for supply in Australia; and

                     (c)  the Secretary has not consented to the exportation; and

                     (d)  the device is not of a kind covered by an exemption in force under section 41GS.

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.

           (13)  A person commits an offence if:

                     (a)  the person exports a medical device from Australia; and

                     (b)  the medical device does not comply with the essential principles relating to matters other than the labelling of the device for supply in Australia; and

                     (c)  the Secretary has not consented to the exportation; and

                     (d)  the device is not of a kind covered by an exemption in force under section 41GS.

Penalty:  100 penalty units.

           (14)  An offence against subsection (13) is an offence of strict liability.

41MAA  Civil penalties for importing, supplying or exporting a medical device that does not comply with essential principles

Civil penalty relating to importing a medical device

             (1)  A person contravenes this subsection if:

                     (a)  the person imports a medical device into Australia; and

                     (b)  the medical device does not comply with the essential principles relating to matters other than the labelling of the device; and

                     (c)  the Secretary has not consented to the importation; and

                     (d)  the device is not of a kind covered by an exemption in force under section 41GS.

Maximum civil penalty:

                     (a)  for an individual—5,000 penalty units; and

                     (b)  for a body corporate—50,000 penalty units.

Civil penalty relating to supplying a medical device

             (2)  A person contravenes this subsection if:

                     (a)  the person supplies a medical device for use in Australia; and

                     (b)  the medical device does not comply with the essential principles; and

                     (c)  the Secretary has not consented to the supply; and

                     (d)  the device is not of a kind covered by an exemption in force under section 41GS.

Maximum civil penalty:

                     (a)  for an individual—5,000 penalty units; and

                     (b)  for a body corporate—50,000 penalty units.

Civil penalty relating to exporting a medical device

             (3)  A person contravenes this subsection if:

                     (a)  the person exports a medical device from Australia; and

                     (b)  the medical device does not comply with the essential principles relating to matters other than the labelling of the device for supply in Australia; and

                     (c)  the Secretary has not consented to the exportation; and

                     (d)  the device is not of a kind covered by an exemption in force under section 41GS.

Maximum civil penalty:

                     (a)  for an individual—5,000 penalty units; and

                     (b)  for a body corporate—50,000 penalty units.

41MB  Exceptions

             (1)  Sections 41MA and 41MAA do not apply if:

                     (a)  the medical device complies with one or more medical device standards that apply to it; and

                     (b)  the medical device fails to comply with the essential principles only in respect of a part or parts of the essential principles to which that medical device standard, or one or more of those medical device standards, relate.

Note:          Medical device standards are determined under Division 2 of Part 4‑2.

             (2)  For the purposes of this section, a medical device standard relates to a part or parts of the essential principles only if the standard specifies that part or parts.

Note 1:       In the prosecution for an offence, the defendant bears an evidential burden in relation to the matters in this section (see subsection 13.3(3) of the Criminal Code).

Note 2:       In proceedings for the contravention of a civil penalty provision, the defendant must prove the matters in this section.

41MC  Criminal offences relating to breaching a condition of a consent

             (1)  The consent of the Secretary under section 41MA or 41MAA may be given:

                     (a)  unconditionally or subject to conditions; or

                     (b)  in respect of particular medical devices or kinds of medical devices.

             (2)  A person commits an offence if:

                     (a)  the person does an act or omits to do an act; and

                     (b)  the act or omission breaches a condition of a consent; and

                     (c)  the act or omission has resulted in, will result in, or is likely to result in, harm or injury to any person.

Penalty:  2,000 penalty units.

Note 1:       A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (5) instead: see section 53A.

Note 2:       For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

             (5)  A person commits an offence if:

                     (a)  the person does an act or omits to do an act; and

                     (b)  the act or omission breaches a condition of a consent.

Penalty:  500 penalty units.

             (6)  A person commits an offence if:

                     (a)  the person does an act or omits to do an act; and

                     (b)  the act or omission breaches a condition of a consent.

Penalty:  100 penalty units.

             (7)  An offence against subsection (6) is an offence of strict liability.

41MCA  Civil penalty relating to breaching a condition of a consent

                   A person contravenes this section if:

                     (a)  the person does an act or omits to do an act; and

                     (b)  the act or omission breaches a condition of a consent imposed under section 41MC.

Maximum civil penalty:

                     (a)  for an individual—3,000 penalty units; and

                     (b)  for a body corporate—30,000 penalty units.

41MD  Treating medical devices as prohibited imports or exports

                   If:

                     (a)  the importation or exportation of a medical device is an offence under subsection 41MA(1), (4), (4A), (9), (12) or (13) or a contravention of subsection 41MAA(1) or (3); and

                     (b)  the Secretary notifies the Comptroller‑General of Customs in writing that the Secretary wishes the Customs Act 1901 to apply to that importation or exportation;

the Customs Act 1901 has effect as if the device included in that importation or exportation were goods described as forfeited to the Crown under section 229 of that Act because they were:

                     (c)  prohibited imports within the meaning of that Act; or

                     (d)  prohibited exports within the meaning of that Act;

as the case requires.

Division 2Failure to apply conformity assessment procedures

41ME  Criminal offences for failing to apply conformity assessment procedures—manufacturers

Offences relating to supplying a medical device

             (1)  A person commits an offence if:

                     (a)  the person manufactures a medical device; and

                     (b)  the person supplies the device in Australia; and

                     (c)  the conformity assessment procedures have not been applied to the device; and

                    (ca)  the device is not of a kind covered by an exemption in force under section 41GS; and

                     (d)  either:

                              (i)  the use of the device has resulted in, will result in, or is likely to result in, harm or injury to any person; or

                             (ii)  the use of the device, if the device were used, would result in, or would be likely to result in, harm or injury to any person; and

                     (e)  the harm or injury has resulted, will result, is likely to result, would result, or would be likely to result, because the conformity assessment procedures have not been applied to the device.

Penalty:  Imprisonment for 5 years or 4,000 penalty units, or both.

Note 1:       A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A.

Note 2:       For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

             (4)  A person commits an offence if:

                     (a)  the person manufactures a medical device; and

                     (b)  the person supplies the device in Australia; and

                     (c)  the conformity assessment procedures have not been applied to the device; and

                     (d)  the device is not of a kind covered by an exemption in force under section 41GS.

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.

          (4A)  A person commits an offence if:

                     (a)  the person manufactures a medical device; and

                     (b)  the person supplies the device in Australia; and

                     (c)  the conformity assessment procedures have not been applied to the device; and

                     (d)  the device is not of a kind covered by an exemption in force under section 41GS.

Penalty:  100 penalty units.

          (4B)  An offence against subsection (4A) is an offence of strict liability.

Offences relating to exporting a medical device

             (5)  A person commits an offence if:

                     (a)  the person manufactures a medical device; and

                     (b)  the person exports the device from Australia; and

                     (c)  the conformity assessment procedures have not been applied to the device; and

                    (ca)  the device is not of a kind covered by an exemption in force under section 41GS; and

                     (d)  either:

                              (i)  the use of the device has resulted in, will result in, or is likely to result in, harm or injury to any person; or

                             (ii)  the use of the device, if the device were used, would result in, or would be likely to result in, harm or injury to any person; and

                     (e)  the harm or injury has resulted, will result, is likely to result, would result, or would be likely to result, because the conformity assessment procedures have not been applied to the device.

Penalty:  Imprisonment for 5 years or 4,000 penalty units, or both.

Note 1:       A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (8) instead: see section 53A.

Note 2:       For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

             (8)  A person commits an offence if:

                     (a)  the person manufactures a medical device; and

                     (b)  the person exports the device from Australia; and

                     (c)  the conformity assessment procedures have not been applied to the device; and

                     (d)  the device is not of a kind covered by an exemption in force under section 41GS.

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.

             (9)  A person commits an offence if:

                     (a)  the person manufactures a medical device; and

                     (b)  the person exports the device from Australia; and

                     (c)  the conformity assessment procedures have not been applied to the device; and

                     (d)  the device is not of a kind covered by an exemption in force under section 41GS.

Penalty:  100 penalty units.

           (10)  An offence against subsection (9) is an offence of strict liability.

41MEA  Civil penalties for failing to apply conformity assessment procedures—manufacturers

Civil penalty relating to supplying a medical device

             (1)  A person contravenes this subsection if:

                     (a)  the person supplies a medical device in Australia; and

                     (b)  the person has manufactured the device; and

                     (c)  the conformity assessment procedures have not been applied to the device; and

                     (d)  the device is not of a kind covered by an exemption in force under section 41GS.

Maximum civil penalty:

                     (a)  for an individual—5,000 penalty units; and

                     (b)  for a body corporate—50,000 penalty units.

Civil penalty relating to exporting a medical device

             (2)  A person contravenes this subsection if:

                     (a)  the person exports a medical device from Australia; and

                     (b)  the person has manufactured the device; and

                     (c)  the conformity assessment procedures have not been applied to the device; and

                     (d)  the device is not of a kind covered by an exemption in force under section 41GS.

Maximum civil penalty:

                     (a)  for an individual—5,000 penalty units; and

                     (b)  for a body corporate—50,000 penalty units.

41MF  Criminal offences for failing to apply conformity assessment procedures—sponsors

Offences relating to supplying a medical device

             (1)  A person commits an offence if:

                     (a)  the person supplies a medical device in Australia; and

                     (b)  the conformity assessment procedures have not been applied to the device; and

                   (ba)  the device is not of a kind covered by an exemption in force under section 41GS; and

                     (c)  either:

                              (i)  the use of the device has resulted in, will result in, or is likely to result in, harm or injury to any person; or

                             (ii)  the use of the device, if the device were used, would result in, or would be likely to result in, harm or injury to any person; and

                     (d)  the harm or injury has resulted, will result, is likely to result, would result, or would be likely to result, because the conformity assessment procedures have not been applied to the device.

Penalty:  Imprisonment for 5 years or 4,000 penalty units, or both.

Note 1:       A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (2) instead: see section 53A.

Note 2:       For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

             (2)  A person commits an offence if:

                     (a)  the person supplies a medical device in Australia; and

                     (b)  the conformity assessment procedures have not been applied to the device; and

                     (c)  the device is not of a kind covered by an exemption in force under section 41GS.

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.

Offences relating to exporting a medical device

             (3)  A person commits an offence if:

                     (a)  the person exports a medical device from Australia; and

                     (b)  the conformity assessment procedures have not been applied to the device; and

                   (ba)  the device is not of a kind covered by an exemption in force under section 41GS; and

                     (c)  either:

                              (i)  the use of the device has resulted in, will result in, or is likely to result in, harm or injury to any person; or

                             (ii)  the use of the device, if the device were used, would result in, or would be likely to result in, harm or injury to any person; and

                     (d)  the harm or injury has resulted, will result, is likely to result, would result, or would be likely to result, because the conformity assessment procedures have not been applied to the device.

Penalty:  Imprisonment for 5 years or 4,000 penalty units, or both.

Note 1:       A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A.

Note 2:       For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

             (4)  A person commits an offence if:

                     (a)  the person exports a medical device from Australia; and

                     (b)  the conformity assessment procedures have not been applied to the device; and

                     (c)  the device is not of a kind covered by an exemption in force under section 41GS.

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.

Exception

             (5)  This section does not apply if the defendant was not the sponsor of the device at the time of the supply or exportation, as the case may be.

Note:          A defendant bears an evidential burden in relation to the matters in subsection (5): see subsection 13.3(3) of the Criminal Code.

41MG  Exceptions

             (1)  Sections 41ME, 41MEA and 41MF do not apply to the extent that:

                     (a)  the quality management systems applied to the medical device comply with one or more conformity assessment standards that apply to them; and

                     (b)  the conformity assessment procedures have not been applied to the device only in respect of a part or parts of the conformity assessment procedures to which one or more of those conformity assessment standards relate.

Note:          Conformity assessment standards are determined under Division 2 of Part 4‑3.

             (2)  For the purposes of this section, a conformity assessment standard relates to a part or parts of the conformity assessment procedures only if the standard specifies that part or parts.

             (3)  Sections 41ME, 41MEA and 41MF do not apply if an overseas regulator conformity assessment document is in force in relation to the medical device.

Note 1:       In the prosecution for an offence, the defendant bears an evidential burden in relation to the matters in this section (see subsection 13.3(3) of the Criminal Code).

Note 2:       In proceedings for the contravention of a civil penalty provision, the defendant must prove the matters in this section.

41MH  Criminal offence for making false statements in declarations

                   A person commits an offence if:

                     (a)  the person makes a statement in or in connection with a declaration, relating to the application of conformity assessment procedures, or the application of requirements comparable to those procedures, to a medical device that the person has manufactured; and

                     (b)  the statement is false or misleading in a material particular.

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.

Note:          For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

41MHA  Civil penalty for making false statements in declarations

                   A person contravenes this section if:

                     (a)  the person manufactures a medical device; and

                     (b)  the person makes a statement in or in connection with a declaration relating to the application of conformity assessment procedures, or the application of requirements comparable to those procedures, to the device; and

                     (c)  the statement is false or misleading in a material particular.

Maximum civil penalty:

                     (a)  for an individual—3,000 penalty units; and

                     (b)  for a body corporate—30,000 penalty units.

Division 3Medical devices not included in the Register and related matters

41MI  Criminal offences for importing, exporting, supplying or manufacturing a medical device not included in the Register

             (1)  A person commits an offence if:

                     (a)  the person:

                              (i)  imports a medical device into Australia; or

                             (ii)  exports a medical device from Australia; or

                            (iii)  supplies a medical device in Australia; or

                            (iv)  manufactures a medical device in Australia; and

                     (b)  none of the following subparagraphs applies in relation to the device:

                              (i)  the device is of a kind included in the Register in relation to the person;

                            (ia)  the device is of a kind covered by an exemption in force under section 41GS;

                             (ii)  the device is an exempt device;

                            (iii)  the device is the subject of an approval under section 41HB or an authority under section 41HC;

                            (iv)  the device is the subject of an approval under subsection 41HD(1), (1A) or (2) that is held by the person; and

                     (c)  either:

                              (i)  the use of the device has resulted in, will result in, or is likely to result in, harm or injury to any person; or

                             (ii)  the use of the device, if the device were used, would result in, or would be likely to result in, harm or injury to any person.

Penalty:  Imprisonment for 5 years or 4,000 penalty units, or both.

Note 1:       A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A.

Note 2:       For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

             (4)  A person commits an offence if:

                     (a)  the person:

                              (i)  imports a medical device into Australia; or

                             (ii)  exports a medical device from Australia; or

                            (iii)  supplies a medical device in Australia; or

                            (iv)  manufactures a medical device in Australia; and

                     (b)  none of the following subparagraphs applies in relation to the device:

                              (i)  the device is of a kind included in the Register in relation to the person;

                            (ia)  the device is of a kind covered by an exemption in force under section 41GS;

                             (ii)  the device is an exempt device;

                            (iii)  the device is the subject of an approval under section 41HB or an authority under section 41HC;

                            (iv)  the device is the subject of an approval under subsection 41HD(1), (1A) or (2) that is held by the person.

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.

             (5)  A person commits an offence if:

                     (a)  the person:

                              (i)  imports a medical device into Australia; or

                             (ii)  exports a medical device from Australia; or

                            (iii)  supplies a medical device in Australia; or

                            (iv)  manufactures a medical device in Australia; and

                     (b)  none of the following subparagraphs applies in relation to the device:

                              (i)  the device is of a kind included in the Register in relation to the person;

                             (ii)  the device is of a kind covered by an exemption in force under section 41GS;

                            (iii)  the device is an exempt device;

                            (iv)  the device is the subject of an approval under section 41HB or an authority under section 41HC;

                             (v)  the device is the subject of an approval under subsection 41HD(1), (1A) or (2) that is held by the person.

Penalty:  100 penalty units.

          (5A)  An offence against subsection (5) is an offence of strict liability.

Defence if person was not the sponsor of the goods

             (6)  It is a defence to a prosecution under subsection (1), (4) or (5) if the defendant proves that the defendant was not the sponsor of the device at the time of the importation, exportation, supply, or manufacture, as the case may be.

Note:          A defendant bears a legal burden in relation to the matters in subsection (6): see section 13.4 of the Criminal Code.

Exception

             (7)  Subsection (1) does not apply if:

                     (a)  harm or injury did not, will not, or is not likely to, directly result from:

                              (i)  the quality, safety or performance of the medical device; or

                             (ii)  a matter relating to the labelling or packaging of the medical device; or

                            (iii)  the improper use of the medical device; or

                     (b)  harm or injury would not, or would not be likely to, directly result from:

                              (i)  the quality, safety or performance of the medical device; or

                             (ii)  a matter relating to the labelling or packaging of the medical device; or

                            (iii)  the improper use of the medical device.

Note:          A defendant bears an evidential burden in relation to the matters in subsection (7): see subsection 13.3(3) of the Criminal Code.

41MIA  Notice required to adduce evidence in support of exception under subsection 41MI(7)

             (1)  If:

                     (a)  a defendant is committed for trial for an offence against subsection 41MI(1); or

                     (b)  an offence against subsection 41MI(1) is to be heard and determined by a court of summary jurisdiction;

the committing magistrate or the court must:

                     (c)  inform the defendant of the requirements of this section; and

                     (d)  cause a copy of this section to be given to the defendant.

             (2)  A defendant must not, without leave of the court, adduce evidence in support of the exception under subsection 41MI(7) unless:

                     (a)  if paragraph (1)(a) applies—more than 21 days before the trial begins; or

                     (b)  if paragraph (1)(b) applies—more than 21 days before the hearing of the offence begins;

he or she gives notice of particulars of the exception.

             (3)  A defendant must not, without leave of the court, call any other person to give evidence in support of the exception unless:

                     (a)  the notice under subsection (2) includes the name and address of the person or, if the name and address is not known to the defendant at the time he or she gives the notice, any information in his or her possession that might be of material assistance in finding the person; and

                     (b)  if the name or the address is not included in the notice—the court is satisfied that the defendant before giving the notice took, and after giving the notice continued to take, all reasonable steps to ascertain the name or address; and

                     (c)  if the name or address is not included in the notice, but the defendant subsequently ascertains the name or address or receives information that might be of material assistance in finding the person—the defendant immediately gives notice of the name, address or other information, as the case may be; and

                     (d)  if the defendant is told by or on behalf of the prosecutor that the person has not been found by the name, or at the address, given by the defendant:

                              (i)  the defendant immediately gives notice of any information in the defendant’s possession that might be of material assistance in finding the person; or

                             (ii)  if the defendant later receives any such information—the defendant immediately gives notice of the information.

             (4)  A notice purporting to be given under this section on behalf of the defendant by his or her legal practitioner is, unless the contrary is proved, taken as having been given with the authority of the defendant.

             (5)  Any evidence tendered to disprove that the exception applies may, subject to direction by the court, be given before or after evidence is given in support of the exception.

             (6)  A notice of particulars of the exception must be given, in writing, to the Director of Public Prosecutions. A notice is taken as having been given if it is:

                     (a)  delivered to or left at the Office of the Director of Public Prosecutions; or

                     (b)  sent by certified mail addressed to the Director of Public Prosecutions at the Office of the Director of Public Prosecutions.

             (7)  In this section:

Director of Public Prosecutions means a person holding office as, or acting as, the Director of Public Prosecutions under the Director of Public Prosecutions Act 1983.

41MIB  Civil penalty for importing, exporting, supplying or manufacturing a medical device not included in the Register

             (1)  A person contravenes this section if:

                     (a)  the person does any of the following:

                              (i)  imports a medical device into Australia;

                             (ii)  exports a medical device from Australia;

                            (iii)  supplies a medical device in Australia;

                            (iv)  manufactures a medical device in Australia; and

                     (b)  none of the following subparagraphs apply in relation to the device:

                              (i)  the device is of a kind included in the Register in relation to the person;

                            (ia)  the device is of a kind covered by an exemption in force under section 41GS;

                             (ii)  the device is an exempt device;

                            (iii)  the device is the subject of an approval under section 41HB or an authority under section 41HC;

                            (iv)  the device is the subject of an approval under subsection 41HD(1), (1A) or (2) that is held by the person.

Maximum civil penalty:

                     (a)  for an individual—5,000 penalty units; and

                     (b)  for a body corporate—50,000 penalty units.

Exception

             (2)  Subsection (1) does not apply if the defendant proves that the defendant was not the sponsor of the device at the time of the importation, exportation, supply, or manufacture, as the case may be.

41MJ  Treating medical devices as prohibited imports or exports

                   If:

                     (a)  the importation or exportation of a medical device is an offence under subsection 41MI(1), (4) or (5) or a contravention of section 41MIB; and

                     (b)  the Secretary notifies the Comptroller‑General of Customs in writing that the Secretary wishes the Customs Act 1901 to apply to that importation or exportation;

the Customs Act 1901 has effect as if the device included in that importation or exportation were goods described as forfeited to the Crown under section 229 of that Act because they were:

                     (c)  prohibited imports within the meaning of that Act; or

                     (d)  prohibited exports within the meaning of that Act;

as the case requires.

41MK  Wholesale supply of medical devices not included in the Register

                   A person commits an offence if:

                     (a)  the person supplies a medical device in Australia; and

                     (b)  none of the following subparagraphs applies in relation to the device:

                              (i)  the device is of a kind included in the Register;

                            (ia)  the device is of a kind covered by an exemption in force under section 41GS;

                             (ii)  the device is an exempt device;

                            (iii)  the device is the subject of an approval under section 41HB or an authority under section 41HC;

                            (iv)  the device is the subject of an approval under subsection 41HD(1), (1A) or (2) that is held by the person; and

                     (c)  the person to whom the device is supplied is not the ultimate consumer of the device.

Penalty:  120 penalty units.

41ML  False advertising about medical devices

             (1)  A person commits an offence if:

                     (a)  the person, by any means, advertises a medical device as being for a purpose; and

                     (b)  the device is of a kind included in the Register; and

                     (c)  the purpose is not a purpose accepted in relation to that inclusion; and

                     (d)  either:

                              (i)  the use of the medical device for the advertised purpose has resulted in, will result in, or is likely to result in, harm or injury to any person; or

                             (ii)  the use of the medical device for the advertised purpose, if the medical device were so used, would result in, or would be likely to result in, harm or injury to any person.

Penalty:  Imprisonment for 5 years or 4,000 penalty units, or both.

             (2)  A person commits an offence if:

                     (a)  the person, by any means, advertises a medical device as being for a purpose; and

                     (b)  the device is of a kind included in the Register; and

                     (c)  the purpose is not a purpose accepted in relation to that inclusion.

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.

             (3)  A person commits an offence if:

                     (a)  the person, by any means, advertises a medical device as being for a purpose; and

                     (b)  the device is of a kind included in the Register; and

                     (c)  the purpose is not a purpose accepted in relation to that inclusion.

Penalty:  100 penalty units.

             (4)  An offence against subsection (3) is an offence of strict liability.

41MLA  Civil penalty for making misrepresentations about medical devices

             (1)  A person contravenes this section if:

                     (a)  the person makes a representation of a kind referred to in subsection (2); and

                     (b)  the representation is false or misleading.

Maximum civil penalty:

                     (a)  for an individual—5,000 penalty units; and

                     (b)  for a body corporate—50,000 penalty units.

             (2)  Subsection (1) applies to the following representations:

                     (a)  representations that medical devices are of a kind included in the Register;

                     (b)  representations that medical devices are exempt devices;

                     (c)  representations that medical devices are the subject of an approval under section 41HB or an authority under section 41HC;

                     (d)  representations that medical devices are the subject of an approval under subsection 41HD(1), (1A) or (2).

41MLB  Civil penalty for false advertising about medical devices

                   A person contravenes this section if:

                     (a)  the person, by any means, advertises a medical device as being for a purpose; and

                     (b)  the device is of a kind included in the Register; and

                     (c)  the purpose is not a purpose accepted in relation to that inclusion.

Maximum civil penalty:

                     (a)  for an individual—5,000 penalty units; and

                     (b)  for a body corporate—50,000 penalty units.

41MN  Criminal offences relating to breaches of conditions

Offences relating to breaching a condition of the inclusion of a kind of medical device in the Register

             (1)  A person commits an offence if:

                     (a)  a kind of medical device is included in the Register in relation to the person; and

                     (b)  the person does an act or omits to do an act; and

                     (c)  the act or omission breaches a condition of the inclusion of the kind of device in the Register; and

                     (d)  the act or omission has resulted in, will result in, or is likely to result in, harm or injury to any person.

Penalty:  Imprisonment for 5 years or 4,000 penalty units, or both.

Note 1:       A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A.

Note 2:       For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

             (4)  A person commits an offence if:

                     (a)  a kind of medical device is included in the Register in relation to the person; and

                     (b)  the person does an act or omits to do an act; and

                     (c)  the act or omission breaches a condition of the inclusion of the kind of device in the Register.

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.

          (4A)  A person commits an offence if:

                     (a)  a kind of medical device is included in the Register in relation to the person; and

                     (b)  the person does an act or omits to do an act; and

                     (c)  the act or omission breaches a condition of the inclusion of the kind of device in the Register.

Penalty:  100 penalty units.

          (4B)  An offence against subsection (4A) is an offence of strict liability.

Offences relating to breaching a condition of a conformity assessment certificate

             (5)  A person commits an offence if:

                     (a)  a conformity assessment certificate is issued in respect of the person; and

                     (b)  the person does an act or omits to do an act; and

                     (c)  the act or omission breaches a condition of the conformity assessment certificate; and

                     (d)  the act or omission has resulted in, will result in, or is likely to result in, harm or injury to a person.

Penalty:  Imprisonment for 5 years or 4,000 penalty units, or both.

Note:          A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (8) instead: see section 53A.

             (8)  A person commits an offence if:

                     (a)  a conformity assessment certificate is issued in respect of the person; and

                     (b)  the person does an act or omits to do an act; and

                     (c)  the act or omission breaches a condition of the conformity assessment certificate.

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.

          (8A)  A person commits an offence if:

                     (a)  a conformity assessment certificate is issued in respect of the person; and

                     (b)  the person does an act or omits to do an act; and

                     (c)  the act or omission breaches a condition of the conformity assessment certificate.

Penalty:  100 penalty units.

          (8B)  An offence against subsection (8A) is an offence of strict liability.

Offence relating to breaching a condition of an exemption or approval, or a condition applicable under regulations

             (9)  A person commits an offence if:

                     (a)  the person does an act or omits to do an act; and

                     (b)  the act or omission breaches:

                              (i)  a condition of an exemption applicable under regulations made for the purposes of section 41HA; or

                             (ii)  a condition of an approval under section 41HB; or

                            (iii)  a condition applicable under regulations made for the purposes of subsection 41HB(7); or

                            (iv)  a condition of an approval under subsection 41HD(1), (1A) or (2).

Penalty:  60 penalty units.

Offences relating to breaching a condition of a conformity assessment body determination

           (10)  An Australian corporation commits an offence if:

                     (a)  the corporation does an act or omits to do an act; and

                     (b)  the act or omission breaches a condition referred to in subsection 41EWA(5); and

                     (c)  the act or omission has resulted in, will result in, or is likely to result in, harm or injury to any person.

Penalty:  20,000 penalty units.

           (11)  An Australian corporation commits an offence if:

                     (a)  the corporation does an act or omits to do an act; and

                     (b)  the act or omission breaches a condition referred to in subsection 41EWA(5).

Penalty:  5,000 penalty units.

           (12)  An Australian corporation commits an offence if:

                     (a)  the corporation does an act or omits to do an act; and

                     (b)  the act or omission breaches a condition referred to in subsection 41EWA(5).

Penalty:  500 penalty units.

           (13)  An offence against subsection (12) is an offence of strict liability.

41MNA  Civil penalties for breaching conditions

             (1)  A person contravenes this subsection if:

                     (a)  a kind of medical device is included in the Register in relation to the person; and

                     (b)  the person does an act or omits to do an act; and

                     (c)  the act or omission breaches a condition of the inclusion of the kind of device in the Register.

Maximum civil penalty:

                     (a)  for an individual—5,000 penalty units; and

                     (b)  for a body corporate—50,000 penalty units.

             (2)  A person contravenes this subsection if:

                     (a)  a conformity assessment certificate is issued in respect of the person; and

                     (b)  the person does an act or omits to do an act; and

                     (c)  the act or omission breaches a condition of the conformity assessment certificate.

Maximum civil penalty:

                     (a)  for an individual—5,000 penalty units; and

                     (b)  for a body corporate—50,000 penalty units.

             (3)  An Australian corporation contravenes this subsection if:

                     (a)  the corporation does an act or omits to do an act; and

                     (b)  the act or omission breaches a condition referred to in subsection 41EWA(5).

Maximum civil penalty:    50,000 penalty units.

Division 3AOffences and civil penalties related to exemptions under Part 4‑6A

41MNB  Criminal offences for breaching a condition of an exemption

             (1)  A person commits an offence if:

                     (a)  the person does an act or omits to do an act in relation to a medical device; and

                     (b)  the device is of a kind covered by an exemption in force under section 41GS; and

                     (c)  the act or omission results in the breach of a condition of the exemption; and

                     (d)  the act or omission is likely to cause a serious risk to public health.

Penalty:  Imprisonment for 5 years or 2,000 penalty units, or both.

Note:          For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

             (2)  Strict liability applies to paragraph (1)(b).

Note:          For strict liability, see section 6.1 of the Criminal Code.

             (3)  A person commits an offence if:

                     (a)  the person does an act or omits to do an act in relation to a medical device; and

                     (b)  the device is of a kind covered by an exemption in force under section 41GS; and

                     (c)  the act or omission results in the breach of a condition of the exemption.

Penalty:  Imprisonment for 4 years or 240 penalty units, or both.

             (4)  Strict liability applies to paragraph (3)(b).

Note:          For strict liability, see section 6.1 of the Criminal Code.

             (5)  A person commits an offence if:

                     (a)  the person does an act or omits to do an act in relation to a medical device; and

                     (b)  the device is of a kind covered by an exemption in force under section 41GS; and

                     (c)  the act or omission results in the breach of a condition of the exemption.

Penalty:  60 penalty units.

             (6)  An offence against subsection (5) is an offence of strict liability.

Note:          For strict liability, see section 6.1 of the Criminal Code.

41MNC  Civil penalty for breaching a condition of an exemption

                   A person contravenes this section if:

                     (a)  the person does an act or omits to do an act in relation to a medical device; and

                     (b)  the device is of a kind covered by an exemption in force under section 41GS; and

                     (c)  the act or omission results in the breach of a condition of the exemption.

Maximum civil penalty:

                     (a)  for an individual—5,000 penalty units; and

                     (b)  for a body corporate—50,000 penalty units.

41MND  Civil penalty for making misrepresentations about medical devices

                   A person contravenes this section if:

                     (a)  the person makes a representation that medical devices are of a kind covered by an exemption in force under section 41GS; and

                     (b)  the representation is false or misleading.

Maximum civil penalty:

                     (a)  for an individual—5,000 penalty units; and

                     (b)  for a body corporate—50,000 penalty units.

Division 4Other offences and civil penalty provisions

41MO  Criminal offences for misusing medical devices exempted for special or experimental uses

             (1)  A person commits an offence if:

                     (a)  the person has been granted an authority under subsection 41HC(1) relating to a specified kind of medical device; and

                     (b)  the person supplies a medical device of that kind:

                              (i)  otherwise than in accordance with the authority; or

                             (ii)  otherwise than in accordance with any conditions to which the authority is subject; or

                            (iii)  otherwise than in accordance with any regulations made for the purpose of subsection 41HC(5); and

                     (c)  either:

                              (i)  the use of the device has resulted in, will result in, or is likely to result in, harm or injury to any person; or

                             (ii)  the use of the device, if the device were used, would result in, or would be likely to result in, harm or injury to any person; and

                     (d)  the harm or injury has resulted, will result, is likely to result, would result, or would be likely to result, because:

                              (i)  the supply is not in accordance with the authority; or

                             (ii)  the supply is not in accordance with the conditions to which the authority is subject; or

                            (iii)  the supply is not in accordance with regulations made for the purpose of subsection 41HC(5).

Penalty:  Imprisonment for 5 years or 4,000 penalty units, or both.

Note:          A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A.

             (4)  A person commits an offence if:

                     (a)  the person has been granted an authority under subsection 41HC(1) relating to a specified kind of medical device; and

                     (b)  the person supplies a medical device of that kind:

                              (i)  otherwise than in accordance with the authority; or

                             (ii)  otherwise than in accordance with any conditions to which the authority is subject; or

                            (iii)  otherwise than in accordance with any regulations made for the purpose of subsection 41HC(5).

Penalty:  500 penalty units.

       (4AA)  A person commits an offence if:

                     (a)  the person has been granted an authority under subsection 41HC(1) relating to a specified kind of medical device; and

                     (b)  the person supplies a medical device of that kind:

                              (i)  otherwise than in accordance with the authority; or

                             (ii)  otherwise than in accordance with any conditions to which the authority is subject; or

                            (iii)  otherwise than in accordance with any regulations made for the purpose of subsection 41HC(5).

Penalty:  100 penalty units.

       (4AB)  An offence against subsection (4AA) is an offence of strict liability.

          (4A)  A person commits an offence if:

                     (a)  the person is a health practitioner; and

                     (b)  the person is included in a class of health practitioners specified in subsection 41HC(6) rules; and

                     (c)  the person supplies a medical device of a kind specified in those rules; and

                     (d)  any of the following applies:

                              (i)  the supply is not in accordance with those rules;

                             (ii)  the supply is not in the circumstances specified in those rules;

                            (iii)  the supply is not in accordance with the conditions specified in those rules; and

                     (e)  either:

                              (i)  the use of the device has resulted in, will result in, or is likely to result in, harm or injury to any person; or

                             (ii)  the use of the device, if the device were used, would result in, or would be likely to result in, harm or injury to any person; and

                      (f)  the harm or injury has resulted, will result, is likely to result, would result, or would be likely to result, because:

                              (i)  the supply is not in accordance with those rules; or

                             (ii)  the supply is not in the circumstances specified in those rules; or

                            (iii)  the supply is not in accordance with the conditions specified in those rules.

Penalty:  Imprisonment for 5 years or 4,000 penalty units, or both.

          (4C)  A person commits an offence if:

                     (a)  the person is a health practitioner; and

                     (b)  the person is included in a class of health practitioners specified in subsection 41HC(6) rules; and

                     (c)  the person supplies a medical device of a kind specified in those rules; and

                     (d)  any of the following applies:

                              (i)  the supply is not in accordance with those rules;

                             (ii)  the supply is not in the circumstances specified in those rules;

                            (iii)  the supply is not in accordance with the conditions specified in those rules.

Penalty:  500 penalty units.

          (4D)  A person commits an offence if:

                     (a)  the person is a health practitioner; and

                     (b)  the person is included in a class of health practitioners specified in subsection 41HC(6) rules; and

                     (c)  the person supplies a medical device of a kind specified in those rules; and

                     (d)  any of the following applies:

                              (i)  the supply is not in accordance with those rules;

                             (ii)  the supply is not in the circumstances specified in those rules;

                            (iii)  the supply is not in accordance with the conditions specified in those rules.

Penalty:  100 penalty units.

          (4E)  An offence against subsection (4D) is an offence of strict liability.

             (5)  A person commits an offence if:

                     (a)  the person has been granted an approval under section 41HB relating to a specified medical device or specified kind of medical device; and

                     (b)  the person uses a medical device of that kind:

                              (i)  in the treatment of another person; or

                             (ii)  solely for experimental purposes in humans;

                            otherwise than in accordance with the approval; and

                     (c)  either:

                              (i)  the use of the device has resulted in, will result in, or is likely to result in, harm or injury to any person; or

                             (ii)  the use of the device, if the device were used, would result in, or would be likely to result in, harm or injury to any person.

Penalty:  Imprisonment for 5 years or 4,000 penalty units, or both.

Note:          A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (8) instead: see section 53A.

             (8)  A person commits an offence if:

                     (a)  the person has been granted an approval under section 41HB relating to a specified medical device or specified kind of medical device; and

                     (b)  the person uses a medical device of that kind:

                              (i)  in the treatment of another person; or

                             (ii)  solely for experimental purposes in humans;

                            otherwise than in accordance with the approval.

Penalty:  500 penalty units.

             (9)  A person commits an offence if:

                     (a)  the person has been granted an approval under section 41HB relating to a specified medical device or specified kind of medical device; and

                     (b)  the person uses a medical device of that kind:

                              (i)  in the treatment of another person; or

                             (ii)  solely for experimental purposes in humans;

                            otherwise than in accordance with the approval.

Penalty:  100 penalty units.

           (10)  An offence against subsection (9) is an offence of strict liability.

41MP  Criminal offence for failing to notify adverse events etc.

             (1)  A person commits an offence if:

                     (a)  the person is a person in relation to whom a kind of medical device is included in the Register; and

                     (b)  the person knows that particular information is information of a kind mentioned in subsection (2); and

                     (c)  the person fails to give that information to the Secretary within the period specified in the regulations (whether or not the person has already given to the Secretary other information relating to the same matter).

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.

Note:          For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

             (2)  The information with which subsection (1) is concerned is information of the following kinds:

                     (a)  information relating to:

                              (i)  any malfunction or deterioration in the characteristics or performance of the kind of device; or

                             (ii)  any inadequacy in the design, production, labelling, instructions for use or advertising materials of the kind of device; or

                            (iii)  any use in accordance with, or contrary to, the use intended by the manufacturer of the kind of device;

                            that might lead, or might have led, to the death of a patient or a user of the device, or to a serious deterioration in his or her state of health;

                     (b)  information relating to any technical or medical reason for a malfunction or deterioration of a kind referred to in subparagraph (a)(i) that has led the manufacturer to take steps to recall devices of that kind that have been distributed;

                     (c)  information that indicates that a device of that kind does not comply with the essential principles;

                     (d)  information that indicates that a certificate or other document (other than a certificate or other document issued by the Secretary under this Act) used for the purpose of an application under subsection 41FC(1) to signify:

                              (i)  compliance with the essential principles; or

                             (ii)  the application of relevant conformity assessment procedures to a device of that kind or the application of requirements, comparable to those procedures, to a device of that kind;

                            has been restricted, suspended, revoked or is no longer in effect.

41MPA  Civil penalty for failing to notify adverse events etc.

             (1)  A person contravenes this section if:

                     (a)  a kind of medical device is included in the Register in relation to the person; and

                     (b)  the information is of a kind mentioned in subsection (2); and

                     (c)  the person does not give information of a kind mentioned in subsection (2) to the Secretary within the period specified in the regulations (whether or not the person has already given to the Secretary other information relating to the same matter).

Maximum civil penalty:

                     (a)  for an individual—3,000 penalty units; and

                     (b)  for a body corporate—30,000 penalty units.

             (2)  The information with which subsection (1) is concerned is information of the following kinds:

                     (a)  information relating to:

                              (i)  any malfunction or deterioration in the characteristics or performance of the kind of device; or

                             (ii)  any inadequacy in the design, production, labelling, instructions for use or advertising materials of the kind of device; or

                            (iii)  any use in accordance with, or contrary to, the use intended by the manufacturer of the kind of device;

                            that might lead, or might have led, to the death of a patient or user of the device, or to a serious deterioration in his or her state of health;

                     (b)  information relating to any technical or medical reason for a malfunction or deterioration of a kind referred to in subparagraph (a)(i) that has led the manufacturer to take steps to recall devices of that kind that have been distributed;

                     (c)  information that indicates that a device of that kind does not comply with the essential principles;

                     (d)  information that indicates that a certificate or other document (other than a certificate or other document issued by the Secretary under this Act) used for the purpose of an application under subsection 41FC(1) to signify:

                              (i)  compliance with the essential principles; or

                             (ii)  the application of relevant conformity assessment procedures to a device of that kind or the application of requirements, comparable to those procedures, to a device of that kind;

                            has been restricted, suspended, revoked or is no longer in effect.

41MPB  Relief from liability for contraventions for failing to notify adverse events etc.

             (1)  If:

                     (a)  proceedings for the contravention of section 41MPA (a civil penalty provision) are brought against a person; and

                     (b)  in the proceedings it appears to the Court that the person has, or may have, contravened that section but that:

                              (i)  the person has a reasonable excuse; and

                             (ii)  having regard to all the circumstances of the case, the person ought fairly to be excused for the contravention;

the Court may relieve the person either wholly or partly from a liability to which the person would otherwise be subject, or that might otherwise be imposed on the person, because of the contravention.

             (2)  If a person thinks that proceedings for the contravention of section 41MPA will or may be begun against them, they may apply to the Court for relief.

             (3)  On an application under subsection (2), the Court may grant relief under subsection (1) as if proceedings had been begun in the Court.

             (4)  For the purposes of subsection (2) as applying for the purposes of a case tried by a judge with a jury:

                     (a)  a reference in that subsection to the Court is a reference to the judge; and

                     (b)  the relief that may be granted includes withdrawing the case in whole or in part from the jury and directing judgment to be entered for the person on such terms as to costs as the judge thinks appropriate.

41MQ  Notification of adverse events etc. where application withdrawn or lapses

             (1)  If an application for inclusion of a kind of medical device in the Register is withdrawn or lapses, the Secretary may give the applicant written notice requiring the applicant:

                     (a)  to inform the Secretary in writing whether the applicant is aware of any information of a kind mentioned in subsection 41MP(2) or 41MPA(2) relating to the kind of device; and

                     (b)  if the applicant is aware of such information, to give the information to the Secretary in writing.

             (2)  Notice under subsection (1) may only be given within 10 working days after an application is withdrawn or lapses.

             (3)  A person commits an offence if the person fails to comply with the requirements of a notice under subsection (1) within 20 working days after the notice is given to the person.

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.

Note:          For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

             (4)  A person commits an offence if:

                     (a)  the person gives information in purported compliance with a notice under this section; and

                     (b)  the information is false or misleading in a material particular.

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.

Note:          For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

41MR  Civil penalties for failing to notify adverse effects etc. where application withdrawn or lapses

Civil penalty for failing to comply with requirements of a notice

             (1)  A person contravenes this subsection if the person does not comply with the requirements of a notice under subsection 41MQ(1) within 20 working days after the day on which the notice is given to the person.

Maximum civil penalty:

                     (a)  for an individual—3,000 penalty units; and

                     (b)  for a body corporate—30,000 penalty units.

Civil penalty for giving false or misleading information in purported compliance with requirements of a notice

             (2)  A person contravenes this subsection if:

                     (a)  the person gives information in purported compliance with a notice under subsection 41MQ(1); and

                     (b)  the information is false or misleading in a material particular.

Maximum civil penalty:

                     (a)  for an individual—3,000 penalty units; and

                     (b)  for a body corporate—30,000 penalty units.

Chapter 5Advertising, counterfeit therapeutic goods and product tampering

Part 5‑1Advertising and generic information

Division 1Preliminary

42AA  This Part not to apply to advertisements directed at health professionals etc.

             (1)  This Part does not apply to advertisements directed exclusively to:

                     (a)  medical practitioners, psychologists, dentists, pharmacists, optometrists, chiropractors, physiotherapists, nurses, midwives, dental hygienists, dental prosthetists, dental therapists or osteopaths; or

                     (b)  persons who are:

                              (i)  engaged in the business of wholesaling therapeutic goods; or

                             (ii)  purchasing officers in hospitals; or

                     (c)  herbalists, homoeopathic practitioners, naturopaths, nutritionists, practitioners of traditional Chinese medicine or podiatrists registered under a law of a State or Territory; or

                     (d)  a class of persons specified under subsection (1A).

          (1A)  The Minister may, by legislative instrument, specify a class of persons for the purposes of paragraph (1)(d).

             (2)  This Part does not apply to advertisements directed exclusively to persons who are members of an Australian branch (however described) of one of the bodies prescribed for the purposes of this subsection.

             (3)  For the purposes of subsection (2), a person is taken to be a member of an Australian branch of one of those bodies if, and only if, the person has the qualifications and training that are necessary or appropriate for membership of the relevant body.

             (4)  This Part does not apply to advice or information given directly to a patient by a person referred to in paragraph (1)(a) or (c) or subsection (2) in the course of treatment of that patient.

42AB  This Part not to apply to advertisements for goods not for human use

                   This Part does not apply to advertisements in respect of goods that are not for use in humans.

42AC  This Part not to apply to advertisements for exported goods

             (1)  Subject to subsection (2), this Part does not apply to advertisements solely for therapeutic goods that have been exported or are intended exclusively for export.

             (2)  Sections 42DKB, 42DLA and 42DLC and Divisions 5 and 6 apply in relation to advertisements of that kind.

42B  Definitions

                   In this Part, unless the contrary intention appears:

generic information, in relation to therapeutic goods, includes any statement, pictorial representation or design, however made, about the composition, properties or other characteristics of therapeutic goods, but does not include:

                     (a)  an advertisement about the goods; or

                     (b)  generic information included in an advertisement about the goods; or

                     (c)  bona fide news.

prohibited representation means a representation referred to in subsection 42DJ(1).

required representation means a representation referred to in subsection 42DJ(2).

restricted representation means a representation referred to in section 42DD.

42BAA  Therapeutic Goods Advertising Code

             (1)  The Minister may, by legislative instrument, make a code relating to advertisements about therapeutic goods.

             (2)  Despite subsection 14(2) of the Legislation Act 2003, an instrument under subsection (1) of this section may make provision in relation to a matter by applying, adopting or incorporating, with or without modification, any matter contained in an instrument or other writing as in force or existing from time to time.

Division 3General provisions about advertising therapeutic goods

42DA  Simplified outline of this Division

Representations in advertisements about therapeutic goods may be restricted representations, required representations or prohibited representations. The offences and civil penalties in Division 3A refer to these 3 kinds of representations.

42DB  Definitions

                   In this Division:

applicant means an applicant for approval of the use of a restricted representation in an advertisement about therapeutic goods.

approval holder, in relation to a restricted representation, means the person to whom notice of approval of the use of the restricted representation was given.

42DD  Restricted representations

                   For the purposes of this Part, a representation in an advertisement about therapeutic goods that refers to a form of a disease, condition, ailment or defect identified in a part of the Therapeutic Goods Advertising Code as a serious form of a disease, condition, ailment or defect is a restricted representation.

Note:          See sections 42DL and 42DLB for offences and a civil penalty for advertising therapeutic goods, where the advertisement contains a restricted representation.

42DE  Applications for approval of use of restricted representation

             (1)  An application for approval of the use of a restricted representation must be made to the Secretary in accordance with a form approved, in writing, by the Secretary.

             (2)  An approval of a form may require or permit an application to be given in accordance with specified software requirements:

                     (a)  on a specified kind of data processing device; or

                     (b)  by way of a specified kind of electronic transmission.

42DF  Approval of use of restricted representation

             (1)  If an application for approval of the use of a restricted representation is made, the Secretary must approve the use of the restricted representation if the Secretary is satisfied that:

                     (a)  the representation is accurate and balanced; and

                     (b)  the representation is not misleading or likely to be misleading.

             (2)  Otherwise, the Secretary must refuse to approve the use of the restricted representation.

             (3)  An approval may be subject to conditions imposed by the Secretary.

             (4)  In deciding whether to approve or refuse to approve the use of a restricted representation, the Secretary must take into consideration:

                     (b)  any advice of a committee that is established under the regulations and is prescribed by the regulations for the purposes of this paragraph; and

                     (c)  the public interest criteria mentioned in the part of the Therapeutic Goods Advertising Code dealing with restricted representations.

42DG  Notice of approval or refusal

             (1)  The Secretary must give written notice to the applicant of the approval of, or of the refusal to approve, the use of a restricted representation.

             (2)  If written notice is not given to the applicant within the period of 60 days after the day on which the application was made (or within such longer period as the Secretary specifies by written notice to the applicant before the end of that period), the Secretary is taken to have approved the use of the restricted representation at the end of the period.

             (3)  If an approval is subject to conditions, the conditions must be set out in the notice.

             (4)  A notice of refusal to approve the use of a restricted representation must:

                     (a)  give the Secretary’s reasons for the refusal; and

                     (b)  inform the applicant of the applicant’s right to have the Secretary’s decision reviewed by the Minister under section 60.

42DH  Variation of conditions of approval

             (1)  The Secretary, by written notice to an approval holder, may vary any condition of approval of the use of a restricted representation.

             (2)  The notice must:

                     (a)  give the Secretary’s reasons for the variation; and

                     (b)  inform the approval holder of the approval holder’s right to have the Secretary’s decision reviewed by the Minister under section 60.

42DI  Withdrawal of approval

             (1)  The Secretary, by written notice, may withdraw the approval of the use of a restricted representation if:

                     (a)  the Secretary is satisfied that:

                              (i)  information given by the applicant in the application was false or incorrect and the Secretary, or the Minister on review of a decision of the Secretary under section 42DF or 42DH, relied on the information in deciding to approve the use of the representation; or

                             (ii)  the restricted representation has become a prohibited representation; or

                            (iii)  there has been a breach of a condition of approval; or

                     (b)  both:

                              (i)  additional information about the safety of the therapeutic goods becomes available; and

                             (ii)  the Secretary is satisfied that, if that information had been available at the time of the approval, the Secretary would not have approved the use of the restricted representation; or

                     (c)  the use of the restricted representation is permitted under subsection 42DK(1).

             (2)  The notice must:

                     (a)  give the Secretary’s reasons for the withdrawal; and

                     (b)  inform the approval holder of the approval holder’s right to have the Secretary’s decision reviewed by the Minister under section 60.

42DJ  Prohibited and required representations

             (1)  For the purposes of this Part, representations of a kind specified in regulations made for the purposes of this subsection are prohibited representations about therapeutic goods of a kind specified in those regulations.

             (2)  For the purposes of this Part, representations of a kind specified in regulations made for the purposes of this subsection are required representations about the therapeutic goods of a kind specified in those regulations.

42DK  Permitted use of restricted or prohibited representations

Restricted representations

             (1)  The Secretary may, by writing, permit the use of specified restricted representations in specified advertisements about specified therapeutic goods.

Prohibited representations

             (2)  The Secretary may, by writing, permit the use of specified prohibited representations:

                     (a)  on the label of specified therapeutic goods; or

                     (b)  on the package in which specified therapeutic goods are contained; or

                     (c)  on any material included with the package in which specified therapeutic goods are contained;

if the Secretary is satisfied that the representations are necessary for the appropriate use of the goods.

             (3)  The Secretary may, by writing, permit the use of specified prohibited representations in specified advertisements about specified therapeutic goods if the Secretary is satisfied that the representations are necessary in the interests of public health.

Conditions

             (4)  A permission under this section may be subject to conditions specified in the permission.

Permission not a legislative instrument

             (5)  A permission under this section is not a legislative instrument.

Publication

             (6)  As soon as practicable after giving a permission under this section, the Secretary must cause the permission to be published on the Department’s website.

Division 3AAdvertising offences and civil penalties

42DKB  Certain representations not to be advertised

             (1)  If a representation in an advertisement about therapeutic goods is false or misleading, the Secretary may, by notice given to a person apparently responsible for:

                     (a)  advertising the therapeutic goods; or

                     (b)  causing the advertising of the therapeutic goods;

prevent that person from advertising the therapeutic goods, or causing the advertising of the therapeutic goods, in circumstances where the advertisement contains that representation (whether in express terms or by necessary implication).

Note:          See sections 42DLA and 42DLC for criminal offences and a civil penalty for contravening the notice.

             (2)  A notice under subsection (1) is not a legislative instrument.

Publication

             (3)  As soon as practicable after giving a notice under subsection (1), the Secretary must cause the notice to be published on the Department’s website.

42DL  Advertising offences—general

             (1)  A person commits an offence if:

                     (a)  the person:

                              (i)  advertises, by any means, therapeutic goods; or

                             (ii)  causes the advertising, by any means, of therapeutic goods; and

                     (b)  subsection (5), (6), (7), (8), (9), (10), (11) or (12) applies to the advertisement; and

                     (c)  either:

                              (i)  the use of the goods in reliance on the advertisement has resulted in, will result in, or is likely to result in, harm or injury to any person; or

                             (ii)  the use of the goods in reliance on the advertisement, if the goods were so used, would result in, or would be likely to result in, harm or injury to any person.

Penalty:  Imprisonment for 5 years or 4,000 penalty units, or both.

             (2)  A person commits an offence if:

                     (a)  the person:

                              (i)  advertises, by any means, therapeutic goods; or

                             (ii)  causes the advertising, by any means, of therapeutic goods; and

                     (b)  subsection (5), (6), (7), (8), (9), (10), (11) or (12) applies to the advertisement.

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.

             (3)  A person commits an offence if:

                     (a)  the person:

                              (i)  advertises, by any means, therapeutic goods; or

                             (ii)  causes the advertising, by any means, of therapeutic goods; and

                     (b)  subsection (5), (6), (7), (8), (9), (10), (11) or (12) applies to the advertisement.

Penalty:  100 penalty units.

             (4)  An offence against subsection (3) is an offence of strict liability.

Contravening provisions

             (5)  This subsection applies to the advertisement if it contains a prohibited representation (whether in express terms or by necessary implication) about the goods and either of the following applies:

                     (a)  no permission under section 42DK is in force in relation to the prohibited representation;

                     (b)  a permission under section 42DK is in force in relation to the prohibited representation but the use of the prohibited representation is not in accordance with the permission or a condition of the permission.

             (6)  This subsection applies to the advertisement if it does not contain a required representation about the goods.

             (7)  This subsection applies to the advertisement if it contains a restricted representation (whether in express terms or by necessary implication) and either of the following applies:

                     (a)  neither an approval under section 42DF nor a permission under section 42DK is in force in relation to the restricted representation;

                     (b)  an approval under section 42DF or a permission under section 42DK is in force in relation to the restricted representation but the use of the restricted representation is not in accordance with the approval or permission or a condition of the approval or permission.

             (8)  This subsection applies to the advertisement if it contains a reference to this Act, other than in a statement of the registration number, listing number or device number of the goods.

             (9)  This subsection applies to the advertisement if it contains a statement, pictorial representation or design suggesting or implying the goods have been recommended or approved by or on behalf of a government or government authority (including a foreign government or foreign government authority), other than:

                     (a)  a statement of the availability of the goods as a pharmaceutical benefit; or

                     (b)  a statement, pictorial representation or design authorised or required by a government or government authority (not including a foreign government or foreign government authority); or

                     (c)  a statement, pictorial representation or design prescribed by the regulations for the purposes of this paragraph.

           (10)  This subsection applies to the advertisement if it refers to substances, or goods containing substances, included in Schedule 3, 4 or 8 to the current Poisons Standard but not in Appendix H of the current Poisons Standard, other than a reference authorised or required by a government or government authority (not including a foreign government or foreign government authority).

           (11)  This subsection applies to the advertisement if it refers to a biological, other than a reference authorised or required by a government or government authority (not including a foreign government or foreign government authority).

           (12)  This subsection applies to the advertisement if it refers to therapeutic goods that are not entered in the Register and that are prescribed by the regulations for the purposes of this subsection, other than a reference authorised or required by a government or government authority (not including a foreign government or foreign government authority).

Continuing offences

           (13)  A person who contravenes subsection (1), (2) or (3) commits a separate offence in respect of each day (including a day of a conviction for the offence or any later day) during which the contravention continues.

           (14)  The maximum penalty for each day that an offence against subsection (1), (2) or (3) continues is 10% of the maximum pecuniary penalty that can be imposed in respect of that offence.

42DLA  Advertising offences—contravening section 42DKB notice

             (1)  A person commits an offence if:

                     (a)  the Secretary has given a notice to the person under section 42DKB in relation to therapeutic goods; and

                     (b)  the person does an act or omits to do an act; and

                     (c)  the act or omission contravenes the notice; and

                     (d)  either:

                              (i)  the use of the goods has resulted in, will result in, or is likely to result in, harm or injury to any person; or

                             (ii)  the use of the goods, if the goods were used, would result in, or would be likely to result in, harm or injury to any person; and

                     (e)  the harm or injury has resulted, will result, is likely to result, would result, or would be likely to result, because of the contravention.

Penalty:  Imprisonment for 5 years or 4,000 penalty units, or both.

             (2)  A person commits an offence if:

                     (a)  the Secretary has given a notice to the person under section 42DKB; and

                     (b)  the person does an act or omits to do an act; and

                     (c)  the act or omission contravenes the notice.

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.

             (3)  A person commits an offence if:

                     (a)  the Secretary has given a notice to the person under section 42DKB; and

                     (b)  the person does an act or omits to do an act; and

                     (c)  the act or omission contravenes the notice.

Penalty:  100 penalty units.

             (4)  An offence against subsection (3) is an offence of strict liability.

42DLB  Civil penalty relating to advertisements—general

             (1)  A person contravenes this subsection if:

                     (a)  the person:

                              (i)  advertises, by any means, therapeutic goods; or

                             (ii)  causes the advertising, by any means, of therapeutic goods; and

                     (b)  subsection (2), (3), (4), (5), (6), (7), (8) or (9) applies to the advertisement.

Maximum civil penalty:

                     (a)  for an individual—5,000 penalty units; and

                     (b)  for a body corporate—50,000 penalty units.

Contravening provisions

             (2)  This subsection applies to the advertisement if it contains a prohibited representation (whether in express terms or by necessary implication) about the goods and either of the following applies:

                     (a)  no permission under section 42DK is in force in relation to the prohibited representation;

                     (b)  a permission under section 42DK is in force in relation to the prohibited representation but the use of the prohibited representation is not in accordance with the permission or a condition of the permission.

             (3)  This subsection applies to the advertisement if it does not contain a required representation about the goods.

             (4)  This subsection applies to the advertisement if it contains a restricted representation (whether in express terms or by necessary implication) and either of the following applies:

                     (a)  neither an approval under section 42DF nor a permission under section 42DK is in force in relation to the restricted representation;

                     (b)  an approval under section 42DF or a permission under section 42DK is in force in relation to the restricted representation but the use of the restricted representation is not in accordance with the approval or permission or a condition of the approval or permission.

             (5)  This subsection applies to the advertisement if it contains a reference to this Act, other than in a statement of the registration number, listing number or device number of the goods.

             (6)  This subsection applies to the advertisement if it contains a statement, pictorial representation or design suggesting or implying the goods have been recommended or approved by or on behalf of a government or government authority (including a foreign government or foreign government authority), other than:

                     (a)  a statement of the availability of the goods as a pharmaceutical benefit; or

                     (b)  a statement, pictorial representation or design authorised or required by a government or government authority (not including a foreign government or foreign government authority); or

                     (c)  a statement, pictorial representation or design prescribed by the regulations for the purposes of this paragraph.

             (7)  This subsection applies to the advertisement if it refers to substances, or goods containing substances, included in Schedule 3, 4 or 8 to the current Poisons Standard but not in Appendix H of the current Poisons Standard, other than a reference authorised or required by a government or government authority (not including a foreign government or foreign government authority).

             (8)  This subsection applies to the advertisement if it refers to a biological, other than a reference authorised or required by a government or government authority (not including a foreign government or foreign government authority).

             (9)  This subsection applies to the advertisement if it refers to therapeutic goods that are not entered in the Register and that are prescribed by the regulations for the purposes of this subsection, other than a reference authorised or required by a government or government authority (not including a foreign government or foreign government authority).

Exception

           (10)  Subsection (1) does not apply if:

                     (a)  the person is a broadcaster, a datacaster, the SBS or a person of a kind prescribed by the regulations for the purposes of this paragraph; and

                     (b)  as a result of steps taken by the person, it was reasonable for the person to assume that subsections (2) to (9) did not apply to the advertisement.

           (11)  In this section:

broadcaster has the meaning given by clause 3 of Schedule 2 to the Broadcasting Services Act 1992.

datacaster means a person who holds a datacasting licence (within the meaning of the Broadcasting Services Act 1992).

SBS has the same meaning as in the Special Broadcasting Service Act 1991.

42DLC  Civil penalty relating to advertisements—contravening section 42DKB notice

                   A person contravenes this section if:

                     (a)  the Secretary has given a notice to the person under section 42DKB; and

                     (b)  the person does an act or omits to do an act; and

                     (c)  the act or omission contravenes the notice.

Maximum civil penalty:

                     (a)  for an individual—5,000 penalty units; and

                     (b)  for a body corporate—50,000 penalty units.

42DM  Offences—non‑compliance with the Therapeutic Goods Advertising Code

             (1)  A person commits an offence if:

                     (a)  the person:

                              (i)  advertises, by any means, therapeutic goods; or

                             (ii)  causes the advertising, by any means, of therapeutic goods; and

                     (b)  the advertisement does not comply with the Therapeutic Goods Advertising Code; and

                     (c)  either:

                              (i)  the use of the goods in reliance on the advertisement has resulted in, will result in, or is likely to result in, harm or injury to any person; or

                             (ii)  the use of the goods in reliance on the advertisement, if the goods were so used, would result in, or would be likely to result in, harm or injury to any person.

Penalty:  Imprisonment for 5 years or 4,000 penalty units, or both.

             (2)  A person commits an offence if:

                     (a)  the person:

                              (i)  advertises, by any means, therapeutic goods; or

                             (ii)  causes the advertising, by any means, of therapeutic goods; and

                     (b)  the advertisement does not comply with the Therapeutic Goods Advertising Code.

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.

             (3)  A person commits an offence if:

                     (a)  the person:

                              (i)  advertises, by any means, therapeutic goods; or

                             (ii)  causes the advertising, by any means, of therapeutic goods; and

                     (b)  the advertisement does not comply with the Therapeutic Goods Advertising Code.

Penalty:  100 penalty units.

             (4)  An offence against subsection (3) is an offence of strict liability.

Continuing offences

             (5)  A person who contravenes subsection (1), (2) or (3) commits a separate offence in respect of each day (including a day of a conviction for the offence or any later day) during which the contravention continues.

             (6)  The maximum penalty for each day that an offence against subsection (1), (2) or (3) continues is 10% of the maximum pecuniary penalty that can be imposed in respect of that offence.

42DMA  Civil penalty—non‑compliance with the Therapeutic Goods Advertising Code

             (1)  A person contravenes this section if:

                     (a)  the person:

                              (i)  advertises, by any means, therapeutic goods; or

                             (ii)  causes the advertising, by any means, of therapeutic goods; and

                     (b)  the advertisement does not comply with the Therapeutic Goods Advertising Code.

Maximum civil penalty:

                     (a)  for an individual—5,000 penalty units; and

                     (b)  for a body corporate—50,000 penalty units.

Exception

             (2)  Subsection (1) does not apply if:

                     (a)  the person is a broadcaster, a datacaster, the SBS or a person of a kind prescribed by the regulations for the purposes of this paragraph; and

                     (b)  as a result of steps taken by the person, it was reasonable for the person to assume that the advertisement complied with the Therapeutic Goods Advertising Code.

             (3)  In this section:

broadcaster has the meaning given by clause 3 of Schedule 2 to the Broadcasting Services Act 1992.

datacaster means a person who holds a datacasting licence (within the meaning of the Broadcasting Services Act 1992).

SBS has the same meaning as in the Special Broadcasting Service Act 1991.

Division 4Generic information about ingredients or components of therapeutic goods

42DN  Application of Division

                   This Division applies to generic information about goods that:

                     (a)  may be used as an ingredient or component in the manufacture of therapeutic goods; and

                     (b)  although not presented for supply as therapeutic goods, come within the meaning of therapeutic goods because they are represented to be:

                              (i)  for therapeutic use; or

                             (ii)  for use as an ingredient or component in the manufacture of other therapeutic goods.

42DO  Compliance with the Code

                   Generic information to which this Division applies must comply with the provisions of the Therapeutic Goods Advertising Code that are prescribed by the regulations for the purposes of this section as if those provisions applied to generic information in the same way as they apply to advertisements.

42DP  Offences—dissemination of generic information

             (1)  A person commits an offence if:

                     (a)  the person disseminates, by any means, generic information about therapeutic goods to the public or a section of the public; and

                     (b)  the dissemination of that generic information does not comply with the provisions of the Therapeutic Goods Advertising Code that are prescribed by regulations for the purposes of section 42DO.

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.

             (2)  A person commits an offence if:

                     (a)  the person disseminates, by any means, generic information about therapeutic goods to the public or a section of the public; and

                     (b)  the dissemination of that generic information does not comply with the provisions of the Therapeutic Goods Advertising Code that are prescribed by regulations for the purposes of section 42DO.

Penalty:  100 penalty units.

             (3)  An offence against subsection (2) is an offence of strict liability.

42DQ  Civil penalty for dissemination of generic information

                   A person contravenes this section if:

                     (a)  the person disseminates, by any means, generic information about therapeutic goods to the public or a section of the public; and

                     (b)  the dissemination of that generic information does not comply with the provisions of the Therapeutic Goods Advertising Code that are prescribed by regulations for the purposes of section 42DO.

Maximum civil penalty:

                     (a)  for an individual—5,000 penalty units; and

                     (b)  for a body corporate—50,000 penalty units.

Division 5Secretary may require information or documents

42DR  Secretary may require information or documents

Advertisements

             (1)  The Secretary may, by written notice given to a person apparently responsible for advertising therapeutic goods, or for causing the advertising of therapeutic goods, require the person to give to the Secretary specified information, or to produce to the Secretary specified documents, relating to the advertisement.

Generic information

             (2)  The Secretary may, by written notice given to a person apparently responsible for disseminating, or for causing the disseminating of, generic information about therapeutic goods to the public or a section of the public, require the person to give to the Secretary specified information, or to produce to the Secretary specified documents, relating to the dissemination.

Manner of compliance

             (3)  The person must give the information, or produce the documents, to the Secretary:

                     (a)  within the period, of not less than 14 days after the day the notice is given, specified in the notice or within such longer period as the Secretary allows; and

                     (b)  in the form specified in the notice.

Note:          Section 42DS contains criminal offences for failing to comply with the notice and for giving false or misleading information or documents and section 42DT contains a civil penalty for giving false or misleading information or documents.

             (4)  The form may require or permit the information to be given, or the documents to be produced, in accordance with specified software requirements:

                     (a)  on a specified kind of data processing device; or

                     (b)  by way of a specified kind of electronic transmission.

Notice not a legislative instrument

             (5)  A notice under subsection (1) or (2) is not a legislative instrument.

42DS  Criminal offences for failing to comply with a notice etc.

             (1)  A person commits an offence if:

                     (a)  the person is given a notice under section 42DR; and

                     (b)  the person fails to comply with the notice.

Penalty:  500 penalty units.

             (2)  A person commits an offence if:

                     (a)  the person is given a notice under section 42DR; and

                     (b)  the person fails to comply with the notice.

Penalty:  100 penalty units.

             (3)  An offence against subsection (2) is an offence of strict liability.

             (4)  A person commits an offence if:

                     (a)  the person is given a notice under section 42DR; and

                     (b)  the person gives information or produces a document in compliance or purported compliance with the notice; and

                     (c)  the information or document is false or misleading in a material particular.

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.

             (5)  A person commits an offence if:

                     (a)  the person is given a notice under section 42DR; and

                     (b)  the person gives information or produces a document in compliance or purported compliance with the notice; and

                     (c)  the information or document is false or misleading in a material particular.

Penalty:  100 penalty units.

             (6)  An offence against subsection (5) is an offence of strict liability.

42DT  Civil penalty for giving false or misleading information or document in compliance with a notice

                   A person contravenes this section if:

                     (a)  the person is given a notice under section 42DR; and

                     (b)  the person gives information or produces a document in compliance or purported compliance with the notice; and

                     (c)  the information or document is false or misleading in a material particular.

Maximum civil penalty:

                     (a)  for an individual—5,000 penalty units; and

                     (b)  for a body corporate—50,000 penalty units.

42DU  Self‑incrimination

             (1)  A person is not excused from giving information or producing a document under section 42DR on the ground that the information or the production of the document might tend to incriminate the person or expose the person to a penalty.

             (2)  However, in the case of an individual:

                     (a)  the information given or the document produced; and

                     (b)  giving the information or producing the document; and

                     (c)  any information, document or thing obtained as a direct or indirect consequence of giving the information or producing the document;

are not admissible in evidence against the individual:

                     (d)  in criminal proceedings, except proceedings for an offence against subsection 42DS(4) or (5); or

                     (e)  in civil proceedings, except proceedings under section 42Y for a contravention of section 42DT.

Division 6Directions about advertisements or generic information

42DV  Directions about advertisements or generic information

Advertisements

             (1)  If, in relation to the advertising of therapeutic goods, the Secretary is satisfied that there has been a contravention of this Act or the regulations, the Secretary may, in writing, direct a person apparently responsible for advertising the therapeutic goods, or for causing the advertising of the therapeutic goods, to do one or more of the following:

                     (a)  cease the advertisement;

                     (b)  make a retraction;

                     (c)  make a correction;

                     (d)  recover any advertisement that is still in circulation;

                     (e)  destroy the advertisement;

                      (f)  cease making a particular claim or representation made by the advertisement.

Generic information

             (2)  If, in relation to the dissemination of generic information about therapeutic goods to the public or a section of the public, the Secretary is satisfied that there has been a contravention of this Act or the regulations, the Secretary may, in writing, direct a person apparently responsible for the dissemination, or for causing the dissemination, to do one or more of the following:

                     (a)  withdraw the generic information;

                     (b)  make a retraction;

                     (c)  make a correction;

                     (d)  recover any generic information that is still in circulation;

                     (e)  destroy the generic information;

                      (f)  cease making a particular claim or representation made by the generic information.

Conditions

             (3)  A direction under subsection (1) or (2) may be subject to conditions specified in the direction.

             (4)  Without limiting subsection (3), the conditions may relate to one or more of the following:

                     (a)  the period for doing a thing the subject of the direction;

                     (b)  in relation to the making of a retraction or correction, either or both of the following:

                              (i)  the form and manner of the retraction or correction;