Therapeutic Goods (Medical Devices) Regulations 2002
Statutory Rules No. 236, 2002
made under the
Therapeutic Goods Act 1989
Compilation No. 39
Compilation date: 1 December 2018
Includes amendments up to: F2018L01434
Registered: 10 December 2018
This compilation includes commenced amendments made by F2017L01692
About this compilation
This compilation
This is a compilation of the Therapeutic Goods (Medical Devices) Regulations 2002 that shows the text of the law as amended and in force on 1 December 2018 (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If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.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
Part 1—Preliminary 1
1.1......................... Name of Regulations.......................................................... 1
1.3......................... Definitions—the dictionary etc........................................... 1
1.4......................... Medical devices with a measuring function........................ 1
1.5......................... Refurbishment (Act s 3(1))................................................. 1
1.6......................... Kinds of medical devices—other common characteristics (Act s 41BE(1)(e)) 2
1.7......................... Device nomenclature system codes (Act s 41BE(3)).......... 2
Part 2—Essential principles 4
2.1......................... Essential principles (Act s 41CA)....................................... 4
Part 3—Conformity assessment procedures 5
Division 3.1—Medical device classifications 5
3.1......................... Medical device classifications (Act s 41DB)...................... 5
3.2......................... Classification of medical devices........................................ 5
3.3......................... Principles for applying the classification rules.................... 5
Division 3.2—Conformity assessment procedures 7
3.4......................... Conformity assessment procedures (Act s 41DA)............. 7
3.5......................... Powers and functions of Secretary in relation to conformity assessment 7
3.6......................... Class III medical devices and Class AIMD medical devices (other than medical devices used for a special purpose).......................................................... 7
3.6A...................... Class 4 IVD medical devices (other than medical devices to be used for a special purpose)............................................................................................ 8
3.6B....................... Class 4 in‑house IVD medical devices (other than medical devices to be used for a special purpose).............................................................................. 8
3.7......................... Class IIb medical devices (other than medical devices used for a special purpose) 8
3.7A...................... Class 3 IVD medical devices (other than devices to be used for a special purpose) 9
3.7B....................... Class 3 in‑house IVD medical devices............................... 9
3.8......................... Class IIa medical devices (other than medical devices used for a special purpose) 9
3.8A...................... Class 2 IVD medical devices (other than devices to be used for a special purpose) 10
3.8B....................... Class 2 in‑house IVD medical devices............................. 10
3.9......................... Class I medical devices (other than medical devices used for a special purpose) 10
3.9A...................... Class 1 IVD medical devices (other than devices to be used for a special purpose) 11
3.9B....................... Class 1 in‑house IVD medical devices............................. 11
3.10....................... Medical devices used for a special purpose...................... 11
3.11....................... Medical devices to which the clinical evaluation procedures must be applied 12
3.12....................... Records to be provided in English.................................... 13
3.13....................... Assessment or verification at intermediate stage of manufacture 13
Part 4—Conformity assessment certificates 14
Division 4.1—Issuing conformity assessment certificates 14
4.1......................... When conformity assessment certificates are required (Act s 41EA) 14
4.2......................... Considering applications for conformity assessment certificates (Act s 41EC) 14
4.3......................... Time for making decision on applications (Act s 41ED, s 63(2)(dc)) 14
Division 4.1A—Conformity assessment (priority applicant) determinations 16
4.3A...................... Application of Division.................................................... 16
4.3B....................... Application for conformity assessment (priority applicant) determination 16
4.3C....................... Making of conformity assessment (priority applicant) determination 16
4.3D...................... Period during which conformity assessment (priority applicant) determination is in force.......................................................................................... 17
4.3E....................... Revocation of conformity assessment (priority applicant) determination 18
Division 4.1B—Content of conformity assessment certificates 19
4.3F....................... Content of conformity assessment certificates.................. 19
Division 4.1C—Conditions 20
4.3G...................... Conditions applying automatically—information about poisons 20
Division 4.2—Suspension of conformity assessment certificates 21
4.4......................... Period for revocation of suspension (Act s 41EP, s 63(2)(db)) 21
Division 4.3—Transfer of conformity assessment certificates 22
4.5......................... Application of Division 4.3.............................................. 22
4.6......................... Death, bankruptcy or winding up of manufacturer........... 22
4.7......................... Disposal of business or amalgamation with another manufacturer 22
4.8......................... Change of name of manufacturer...................................... 23
4.9......................... Effect of conformity assessment certificate after transfer, etc 23
4.10....................... Notification to Secretary of events.................................... 23
4.11....................... Notification of change of name or suspension or revocation of conformity assessment certificate........................................................................... 23
Part 4A—Australian conformity assessment bodies 25
Division 4A.1—Preliminary 25
4A.1...................... Purposes of this Part......................................................... 25
Division 4A.2—Making conformity assessment body determinations 26
4A.2...................... Applications...................................................................... 26
4A.3...................... Further information........................................................... 26
4A.4...................... Documents to be provided in English............................... 27
4A.5...................... Lapsing of applications..................................................... 27
4A.6...................... Assessing applications...................................................... 27
4A.7...................... Procedure following decisions to make determinations.... 29
4A.8...................... Duration of determinations............................................... 29
4A.9...................... Procedure following decisions not to make determinations 30
Division 4A.3—Conditions on conformity assessment body determinations 31
Subdivision A—Automatic conditions on determinations 31
4A.10.................... Automatic conditions on determinations........................... 31
4A.11.................... Conditions—requirements of Schedule 3AA................... 31
4A.12.................... Conditions—notifying Secretary and clients..................... 31
4A.13.................... Conditions—entry and inspection..................................... 31
4A.14.................... Conditions—producing information and documents........ 32
4A.15.................... Conditions—reviews........................................................ 32
4A.16.................... Conditions—record keeping............................................. 32
4A.17.................... Conditions—Australian conformity assessment body certificates 33
4A.18.................... Conditions—clients.......................................................... 34
Subdivision B—Conditions specified in conformity assessment body determinations 34
4A.19.................... Conditions specified in determinations............................. 34
Division 4A.4—Suspension of conformity assessment body determinations 35
4A.20.................... Suspension of determinations........................................... 35
4A.21.................... Notice of proposed suspension......................................... 35
4A.22.................... Duration of suspension..................................................... 35
4A.23.................... Revocation of suspension................................................. 36
4A.24.................... Powers of revocation of determinations unaffected.......... 36
Division 4A.5—Revocation of conformity assessment body determinations 37
4A.25.................... Automatic revocation of determinations............................ 37
4A.26.................... Immediate revocation of determinations............................ 37
4A.27.................... Revocation of determinations after notice of proposed revocation 37
Division 4A.6—Variation of conformity assessment body determinations 40
4A.28.................... Imposing, varying or removing conditions....................... 40
4A.29.................... Limiting determinations.................................................... 40
4A.30.................... Notice of proposed variation............................................. 41
Division 4A.7—Australian conformity assessment body certificates 42
4A.31.................... Content of Australian conformity assessment body certificates 42
Part 5—Including medical devices in the Register 43
Division 5.1—Including medical devices in the Register 43
Subdivision A—Applications 43
5.2......................... Matters to be certified—period for obtaining information from manufacturer (Act s 41FD).......................................................................................... 43
Subdivision C—Auditing of applications 43
5.3......................... Selecting applications for auditing (Act s 41FH).............. 43
Subdivision D—Miscellaneous—medical devices (priority applicant) determinations 44
5.4......................... Application of Subdivision............................................... 44
5.4A...................... Application for medical devices (priority applicant) determination 44
5.4B....................... Making of medical devices (priority applicant) determination 45
5.4C....................... Period during which medical devices (priority applicant) determination is in force 46
5.4D...................... Revocation of medical devices (priority applicant) determination 46
Division 5.2—Conditions 47
5.6......................... Conditions applying automatically—period for obtaining information from manufacturer (Act s 41FN).................................................................... 47
5.7......................... Conditions applying automatically—period for giving information about adverse events etc (Act s 41FN).................................................................... 47
5.8......................... Conditions applying automatically—requirements in relation to information about kind of medical device (Act s 41FN)............................................ 48
5.9......................... Conditions applying automatically—storage and transport of medical devices (Act s 41FN).......................................................................................... 48
5.10....................... Conditions applying automatically—record‑keeping (Act s 41FN) 48
5.11....................... Conditions applying automatically—reporting (Act s 41FN).. 49
5.12....................... Conditions applying automatically—notification of information relating to certain IVD medical devices (Act s 41FN)........................................... 49
5.13....................... Conditions applying automatically—information about poisons (Act s 41FN) 50
Part 6—Suspension and cancellation from the Register 51
6.1......................... Period for revocation of suspension (Act s 41GD, s 63(2)(dd)) 51
Part 6A—Disposal of unused emergency medical devices 52
6A.1...................... Disposal of unused emergency medical devices............... 52
Part 7—Exempting medical devices from inclusion in the Register 53
Division 7.1—Exempt devices 53
7.1......................... Exempt devices—general (Act s 41HA)........................... 53
7.2......................... Exempt devices—use in life‑threatening cases (Act s 41HA) 53
Division 7.2—Exemptions for experimental uses 55
7.3......................... Conditions of approval—use of device by person to whom approval is given (Act s 41HB).......................................................................................... 55
7.4......................... Powers of authorised persons in relation to medical devices being used in clinical trials.......................................................................................... 55
7.5......................... Conditions of approval—use of device by another person (Act s 41HB) 56
Division 7.3—Exemptions for medical practitioners 57
7.6......................... Classes of medical practitioners and recipients (Act s 41HC) 57
7.7......................... Circumstances for supply of device under authority (Act s 41HC) 57
7.8......................... Information to be notified in relation to supply of certain medical devices 57
Part 8—Obtaining information 59
8.1A...................... Matters for which information and documents can be requested 59
8.1......................... Notice period (Act s 41JA)............................................... 59
Part 9—Fees 61
Division 9.1—Fees 61
9.1......................... Fees.................................................................................. 61
Division 9.2—Conformity assessment body determination assessment fees 62
9.1A...................... Purposes of this Division................................................. 62
9.1B....................... Conformity assessment body determination assessment fees.. 62
9.1C....................... Conformity assessment body determination assessment fees—abridged assessment.......................................................................................... 62
9.1D...................... Payment of conformity assessment body determination assessment fees by instalments.......................................................................................... 62
9.1E....................... Recovery of conformity assessment body determination assessment fees 63
9.1F....................... Refund of conformity assessment body determination assessment fees if applications withdrawn......................................................................... 63
Division 9.3—Assessment fees 65
9.2......................... Application audit assessment fee (Act ss 41LA, 41LB)... 65
9.3......................... Conformity assessment fee (Act ss 41LA, 41LB)............ 65
9.5......................... Payment of assessment fee by instalments (Act s 41LC).. 65
9.6......................... Reduction of assessment fees........................................... 66
9.7......................... Reduction of assessment fees—abridged assessment....... 67
Part 10—Miscellaneous 68
10.1....................... Authorised persons........................................................... 68
10.2....................... Information about sponsor................................................ 68
10.3....................... Custom‑made medical devices—information about manufacturer 68
10.4....................... Offences—period for notifying adverse events (Act s 41MP) 69
10.4A.................... Secretary may maintain a system to enhance safe and effective use of particular medical devices.............................................................................. 69
10.5....................... Delegation—powers and functions under these Regulations 70
10.6....................... Delegation—powers under paragraph 41HB(1)(d) of the Act 70
10.6A.................... Delegation of Secretary’s powers under section 41HD of the Act 71
10.6B..................... Forms or manners—software requirements...................... 71
10.7....................... Review of decisions.......................................................... 71
Part 11—Transitional provisions 74
Division 11.1—Transitional provisions relating to the Therapeutic Goods (Medical Devices) Amendment Regulations 2010 (No. 1) 74
Subdivision A—Preliminary 74
11.1....................... Interpretation..................................................................... 74
11.2....................... Application of 2010 Amendment Regulations.................. 76
Subdivision B—General provisions relating to transitional devices 76
11.3....................... Application of this Subdivision........................................ 76
11.4....................... Transitional devices exempted from requirement to be included in the Register 76
11.5....................... Essential principles for transitional devices....................... 77
Subdivision C—Listed or registered transitional devices and exempt transitional devices 77
11.6....................... Application of this Subdivision........................................ 77
11.7....................... Application of 2010 Amendment Regulations—certain purposes 77
11.8....................... Application of 2010 Amendment Regulations—conformity assessment certificate required and applied for before 1 September 2014......................... 77
11.9....................... Application of 2010 Amendment Regulations—conformity assessment certificate required but not applied for before 1 September 2014.................... 79
11.10..................... Application of 2010 Amendment Regulations—conformity assessment certificate not required............................................................................. 80
11.11..................... Cancellation of listing or registration................................ 80
Subdivision D—Approved transitional devices 80
11.12..................... Application of this Subdivision........................................ 80
11.13..................... Application of 2010 Amendment Regulations—certain purposes 81
11.14..................... Application of 2010 Amendment Regulations—all purposes 81
Subdivision E—Class 4 in‑house IVD medical devices 81
11.15..................... Application of this Subdivision........................................ 81
11.16..................... Application of 2010 Amendment Regulations—certain purposes 81
11.17..................... Application of 2010 Amendment Regulations—conformity assessment certificate applied for before 1 July 2016............................................................ 82
11.18..................... Application of 2010 Amendment Regulations—devices not covered by regulation 11.17.......................................................................................... 84
Subdivision F—Class 1, 2 and 3 in‑house IVD medical devices 84
11.20..................... Application of this Subdivision........................................ 84
11.21..................... Application of 2010 Amendment Regulations for all purposes 85
Division 11.2—Transitional provisions relating to joint replacements 86
11.22A.................. Purpose of this Division................................................... 86
11.22..................... Certain Class IIb medical devices..................................... 86
11.23..................... Refund of fees in relation to inclusion of certain devices in the Register as Class III medical devices.............................................................................. 87
Division 11.3—Transitional provisions relating to the Therapeutic Goods (Medical Devices) Amendment (In Vitro Diagnostic Medical Devices) Regulation 2015 88
11.24..................... Definitions........................................................................ 88
11.25..................... Application of 2015 Amendment Regulations—transitional Class 4 in‑house IVD medical devices.............................................................................. 88
11.26..................... Application of 2015 Amendment Regulations etc.—transitional Class 1, 2 and 3 in‑house IVD medical devices......................................................... 88
Division 11.4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 90
11.27..................... Application....................................................................... 90
Division 11.5—Transitional provisions relating to the Therapeutic Goods (Medical Devices) Amendment (Implantable Medical Devices) Regulations 2017 91
11.28..................... Definitions........................................................................ 91
11.29..................... Surgical mesh—application of amendments..................... 91
11.30..................... Surgical mesh—Secretary must be notified of unique product identifiers of devices supplied under pre‑commencement entries...................................... 92
11.31..................... Patient information—application of amendments.............. 93
Division 11.6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017 95
11.32..................... Definitions........................................................................ 95
11.33..................... Application—statements in relation to exempt devices..... 95
Division 11.7—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 96
11.34..................... Application of amendments.............................................. 96
Division 11.8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018 97
11.35..................... Application—regulation 4.3G (conditions applying automatically to conformity assessment certificates)........................................................................ 97
11.36..................... Application—regulation 5.13 (conditions applying automatically to medical devices included in the Register).................................................................. 97
Division 11.9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 98
11.37..................... Application of table item 1.5 in Part 1 of Schedule 5........ 98
Schedule 1—Essential principles 99
Part 1—General principles 99
1............................ Use of medical devices not to compromise health and safety 99
2............................ Design and construction of medical devices to conform with safety principles 99
3............................ Medical devices to be suitable for intended purpose......... 99
4............................ Long‑term safety............................................................. 100
5............................ Medical devices not to be adversely affected by transport or storage 100
6............................ Benefits of medical devices to outweigh any undesirable effects 100
Part 2—Principles about design and construction 101
7............................ Chemical, physical and biological properties.................. 101
7.1......................... Choice of materials......................................................... 101
7.2......................... Minimisation of risks associated with contaminants and residues 101
7.3......................... Ability to be used safely with materials etc..................... 101
7.4......................... Verification of incorporated substance............................ 101
7.5......................... Minimisation of risks associated with leaching substances 102
7.6......................... Minimisation of risks associated with ingress or egress of substances 102
8............................ Infection and microbial contamination............................ 102
8.1......................... Minimisation of risk of infection and contamination....... 102
8.2......................... Control of animal, microbial or recombinant tissues, tissue derivatives, cells and other substances....................................................................... 102
8.3......................... Medical devices to be supplied in a sterile state.............. 103
8.4......................... Medical devices to be supplied in a non‑sterile state....... 103
8.5......................... Distinction between medical devices supplied in sterile and non‑sterile state 103
9............................ Construction and environmental properties..................... 104
9.1......................... Medical devices intended to be used in combination with other devices or equipment........................................................................................ 104
9.2......................... Minimisation of risks associated with use of medical devices 104
10.......................... Medical devices with a measuring function.................... 104
11.......................... Protection against radiation............................................. 105
11.1....................... Minimisation of exposure to radiation............................ 105
11.2....................... Medical devices intended to emit radiation...................... 105
11.3....................... Minimisation of exposure to unintended radiation.......... 105
11.4....................... Operating instructions..................................................... 105
11.5....................... Medical devices intended to emit ionising radiation—additional requirements 105
12.......................... Medical devices connected to or equipped with an energy source 106
12.1....................... Medical devices incorporating electronic programmable systems 106
12.2....................... Safety dependent on internal power supply.................... 106
12.3....................... Safety dependent on external power supply.................... 106
12.4....................... Medical devices intended to monitor clinical parameters. 106
12.5....................... Minimisation of risk of electromagnetic fields................ 107
12.6....................... Protection against electrical risks.................................... 107
12.7....................... Protection against mechanical risks................................. 107
12.8....................... Protection against risks associated with vibration........... 107
12.9....................... Protection against risks associated with noise................. 107
12.10..................... Protection against risks associated with terminals and connectors 107
12.11..................... Protection against risks associated with heat................... 108
12.12..................... Protection against risks associated with administration of energy or substances 108
12.13..................... Active implantable medical devices................................. 108
13.......................... Information to be provided with medical devices............ 108
13.1....................... Information to be provided with medical devices—general 108
13.2....................... Information to be provided with medical devices—location 109
13.3....................... Information to be provided with medical devices—particular requirements 110
13.4....................... Instructions for use......................................................... 110
13A....................... Patient implant cards and patient information leaflets...... 113
13A.1.................... Scope of clauses 13A.2 to 13A.4................................... 113
13A.2.................... Patient implant cards for implantable devices.................. 113
13A.3.................... Patient information leaflets for implantable devices........ 113
13A.4.................... Form of patient implant cards and patient information leaflets 115
14.......................... Clinical evidence............................................................. 115
15.......................... Principles applying to IVD medical devices only........... 115
Schedule 2—Classification rules for medical devices other than IVD medical devices 116
Part 1—Interpretation 116
1.1......................... Transient, short‑term and long‑term use......................... 116
Part 2—Rules for non‑invasive medical devices 117
2.1......................... Non‑invasive medical devices—general......................... 117
2.2......................... Non‑invasive medical devices intended to channel or store blood, etc 117
2.3......................... Non‑invasive medical devices intended to modify the biological or chemical composition of blood, etc........................................................................ 117
2.4......................... Non‑invasive medical devices intended to have contact with injured skin 117
Part 3—Rules for invasive medical devices and implantable medical devices 119
3.1......................... Invasive medical devices intended to be used by penetration of body orifices 119
3.2......................... Surgically invasive medical devices intended for transient use 119
3.3......................... Surgically invasive medical devices intended for short‑term use 120
3.4......................... Surgically invasive medical devices intended for long‑term use and implantable medical devices............................................................................ 120
Part 4—Special rules for active medical devices 122
4.1......................... Active medical devices—general.................................... 122
4.2......................... Active medical devices for therapy................................. 122
4.3......................... Active medical devices for diagnosis.............................. 122
4.4......................... Active medical devices intended to administer or remove medicines, etc from a patient’s body........................................................................................ 123
Part 5—Special rules for particular kinds of medical devices 124
5.1......................... Medical devices incorporating a medicine....................... 124
5.2......................... Medical devices intended for contraception or prevention of sexually transmitted diseases........................................................................................ 124
5.3......................... Medical devices intended for disinfecting, cleaning, etc.. 124
5.4......................... Non‑active medical devices intended to record X‑ray diagnostic images 124
5.5......................... Medical devices containing non‑viable animal tissues, cells or other substances, or microbial or recombinant tissues, cells or other substances............ 125
5.6......................... Medical devices that are blood bags................................ 125
5.7......................... Active implantable medical devices................................. 125
5.8......................... Medical devices intended for export only....................... 125
5.9......................... Medical devices that are mammary implants................... 125
Schedule 2A—Classification rules for IVD medical devices 126
1.1......................... Detection of transmissible agents posing high public health risk 126
1.2......................... Detection of red blood cell antigens and antibodies and non‑red cell typing 126
1.3......................... Detection of transmissible agents or biological characteristics posing moderate public health risk or high personal risk................................................ 126
1.4......................... IVD medical devices for self‑testing............................... 127
1.5......................... Non assay‑specific quality control material..................... 127
1.6......................... Reagents, instruments etc................................................ 127
1.7......................... Other IVD medical devices are Class 2 IVD medical devices 128
1.8......................... IVD medical devices intended for export only................ 128
Schedule 3—Conformity assessment procedures 129
Part 1—Full quality assurance procedures 129
1.1......................... Overview........................................................................ 129
1.2......................... References to kinds of medical devices........................... 129
1.3......................... Implementation and assessment of quality management system 129
1.4......................... Requirements of quality management system................. 130
1.5......................... Changes to quality management system or kinds of medical device to which system is to be applied............................................................................ 133
1.6......................... Examination of design of Class 4 IVD medical device, Class 4 in‑house IVD medical device, Class AIMD medical device or Class III medical device 133
1.7......................... Information to be given to authorised person.................. 134
1.8......................... Declaration of conformity............................................... 135
1.9......................... Records........................................................................... 136
Part 2—Type examination procedures 137
2.1......................... Overview........................................................................ 137
2.2......................... References to kinds of medical devices........................... 137
2.3......................... Examination of type........................................................ 137
2.4......................... Changes to design of medical device after examination.. 138
2.5......................... Records........................................................................... 139
Part 3—Verification procedures 140
3.1......................... Overview........................................................................ 140
3.2......................... References to kinds of medical devices........................... 140
3.3......................... Verification of conformity.............................................. 140
3.4......................... Requirements of manufacturing system.......................... 141
3.5......................... Declaration of conformity............................................... 143
3.6......................... Records........................................................................... 144
Part 4—Production quality assurance procedures 145
4.1......................... Overview........................................................................ 145
4.2......................... References to kinds of medical devices........................... 145
4.3......................... Implementation and assessment of production quality management system 145
4.4......................... Requirements of production quality management system 146
4.5......................... Changes to production quality management system........ 148
4.6......................... Information to be given to authorised person.................. 149
4.7......................... Declaration of conformity............................................... 149
4.8......................... Records........................................................................... 150
Part 5—Product quality assurance procedures 151
5.1......................... Overview........................................................................ 151
5.2......................... References to kinds of medical devices........................... 151
5.3......................... Implementation and assessment of product quality management system 151
5.4......................... Requirements of product quality management system.... 152
5.5......................... Changes to product quality management system or kinds of medical device 154
5.6......................... Information to be given to authorised person.................. 154
5.7......................... Declaration of conformity............................................... 155
5.8......................... Records........................................................................... 156
Part 6—Declaration of conformity (not requiring assessment by Secretary) procedures 157
6.1......................... Overview........................................................................ 157
6.2......................... References to kinds of medical devices........................... 157
6.3......................... Implementation............................................................... 157
6.4......................... Required technical documentation................................... 157
6.5......................... Post‑marketing system.................................................... 158
6.6......................... Declaration of conformity............................................... 159
6.7......................... Records........................................................................... 160
Part 6A—Procedures applying to Class 1, 2 and 3 in‑house IVD medical devices 162
6A.1...................... Overview........................................................................ 162
6A.2...................... Procedures...................................................................... 162
6A.3...................... Information to be given to the Secretary......................... 163
6A.4...................... Post‑marketing system.................................................... 165
Part 6B—Procedures applying to Class 4 in‑house IVD medical devices 166
6B.1....................... Overview........................................................................ 166
6B.2....................... References to kinds of medical devices........................... 166
6B.3....................... Procedures...................................................................... 166
6B.4....................... Required technical documentation................................... 167
6B.5....................... Post‑marketing system.................................................... 168
6B.6....................... Declaration of conformity............................................... 168
6B.7....................... Records........................................................................... 169
Part 7—Procedures for medical devices used for a special purpose 170
7.1......................... Overview........................................................................ 170
7.2......................... Custom‑made medical devices........................................ 170
7.5......................... System or procedure packs............................................. 171
7.6......................... Records........................................................................... 173
Part 8—Clinical evaluation procedures 174
8.1......................... Overview........................................................................ 174
8.2......................... References to kinds of medical devices........................... 174
8.3......................... Obtaining clinical data..................................................... 174
8.4......................... Clinical investigation data............................................... 174
8.5......................... Literature review............................................................. 175
8.6......................... Evaluation of clinical data............................................... 175
Schedule 3AA—Requirements for Australian conformity assessment bodies 176
1............................ Purpose of this Schedule................................................ 176
2............................ EU Regulations............................................................... 176
3............................ Modifications of EU Regulations—general.................... 176
4............................ Additional requirements.................................................. 179
5............................ Additional modifications of EU medical devices regulations 179
6............................ Modifications of EU IVD regulations............................ 180
7............................ Expressions used in modifications.................................. 180
Schedule 3A—Disposal of unused emergency medical devices 181
1............................ Early end of exemption—notice of medical devices held 181
2............................ End of exemption period—notice of medical devices held 181
3............................ Storage and disposal of unused emergency medical devices 181
4............................ Direction for disposal of unused emergency medical devices 182
5............................ Relocation of unused emergency medical devices........... 182
6............................ Disposal of unused emergency medical devices—destruction 182
7............................ Disposal of unused emergency medical devices—export 183
8............................ Disposal of unused emergency medical devices—supply 183
9............................ Owner to be paid for medical devices supplied............... 184
10.......................... Records about unused emergency medical devices......... 184
11.......................... Failure to comply with this Schedule.............................. 184
Schedule 4—Exempt devices 185
Part 1—Exempt devices—general 185
Part 2—Exempt devices—exemption subject to conditions 187
Schedule 5—Fees 193
Part 1—General 193
Part 2—Additional fees 201
2.1......................... Supplementary assessment............................................. 201
2.2......................... Costs of testing............................................................... 201
Dictionary 202
Endnotes 210
Endnote 1—About the endnotes 210
Endnote 2—Abbreviation key 211
Endnote 3—Legislation history 212
Endnote 4—Amendment history 215
Endnote 5—Editorial changes 224
Part 1—Preliminary
1.1 Name of Regulations
These Regulations are the Therapeutic Goods (Medical Devices) Regulations 2002.
1.3 Definitions—the dictionary etc
(1) The dictionary at the end of these Regulations defines certain words and expressions, and includes, for that purpose, references to certain words and expressions that are defined in the Act or elsewhere in these Regulations (signpost definitions).
Example: The signpost definition ‘medical device—see section 41BD of the Act’ means that the expression medical device is defined in section 41BD of the Therapeutic Goods Act 1989.
Note: The dictionary only includes a signpost definition for a word or expression that is defined elsewhere in these Regulations if the word or expression is used in more than one regulation.
(2) The dictionary is part of these Regulations.
(3) A definition in these Regulations applies to each use of the word or expression in these Regulations, unless the contrary intention appears.
1.4 Medical devices with a measuring function
(1) For these Regulations, a medical device has a measuring function if the device is intended by the manufacturer to measure:
(a) quantitatively a physiological or anatomical parameter; or
(b) a quantity, or a qualifiable characteristic, of energy or substances delivered to or removed from the human body.
(2) This regulation does not apply to an IVD medical device.
1.5 Refurbishment (Act s 3(1))
(1) A refurbishment of a medical device is taken to have occurred if the medical device, or a part of the device, is substantially rebuilt from one or more used medical devices of that kind so as to create a medical device that is able to be used for the purpose originally intended by the manufacturer of the original device.
(2) Without limiting subregulation (1), a refurbishment of a medical device may involve the following actions:
(a) stripping the device into component parts or sub‑assemblies;
(b) checking parts of the device for suitability for reuse;
(c) replacing component parts or sub‑assemblies of the device that are not suitable for reuse;
(d) assembling reclaimed or replacement component parts or sub‑assemblies of the device or another used device;
(e) testing a reassembled device against the specifications of the original device or, if the manufacturer has revised those specifications, the revised specifications;
(f) identifying an assembled device as a refurbished device.
1.6 Kinds of medical devices—other common characteristics (Act s 41BE(1)(e))
For paragraph 41BE(1)(e) of the Act, in relation to any of the following medical devices, a characteristic is the unique product identifier given to the device by its manufacturer to identify the device and any variants:
(a) a Class 4 IVD medical device, other than an immunohaematology reagent IVD medical device that is a Class 4 IVD medical device;
(b) a Class AIMD medical device;
(c) a Class III medical device.
1.7 Device nomenclature system codes (Act s 41BE(3))
(1) In accordance with the Global Medical Device Nomenclature System Code, as set out in ISO 15225:2000(E), the device nomenclature system code specified for a medical device is:
(a) for a Class 4 IVD medical device—the relevant preferred term; and
(b) for a Class 4 IVD medical device that is an immunohaematology reagent IVD medical device—the relevant Level 2 collective term; and
(c) for a Class 3 IVD medical device—the relevant Level 3 collective term, or if no Level 3 collective term exists, the relevant Level 2 collective term; and
(d) for a Class 2 IVD medical device—the relevant Level 2 collective term; and
(e) for a Class 1 IVD medical device or an export only IVD medical device—the relevant Level 1 collective term; and
(f) for a Class AIMD medical device, Class III medical device, Class IIb medical device or Class IIa medical device—the relevant preferred term; and
(g) for any of the following—the relevant preferred term:
(i) a Class I medical device that the manufacturer intends to be supplied in a sterile state;
(ii) a Class I medical device that has a measuring function;
(iii) a Class I medical device for which there is no relevant template term; and
(h) for any other Class I medical device—the relevant template term.
(2) In this regulation:
collective term means a term that:
(a) is used for those medical devices that share common features; and
(b) is identified in the Global Medical Device Nomenclature System Code; and
(c) is included in the document Collective terms available as device nomenclature system codes for IVD medical devices for the purposes of section 41BE(3) of the Act, published by the Therapeutic Goods Administration, as updated from time to time.
Examples:
Examples of the use of a collective term include the following:
(a) to illustrate the scope of certificates issued by conformity assessment bodies when assessing which groups, families or types of medical devices are covered within a manufacturer’s quality system;
(b) to identify the range of skills and general technological abilities for which a conformity assessment body has been approved and is so appointed by the relevant regulatory authority;
(c) for the exchange of information between regulatory authorities when general information on individual manufacturers’ capabilities is notified.
ISO 15225:2000(E) means International Standard ISO 15225:2000(E) (Nomenclature—Specification for a nomenclature system for medical devices for the purposes of regulatory data exchange).
relevant preferred term, for a medical device, means the preferred term for that device under ISO 15225:2000(E).
relevant template term, for a medical device, means the template term for that device under ISO 15225:2000(E).
Part 2—Essential principles
2.1 Essential principles (Act s 41CA)
For section 41CA of the Act, the essential principles for medical devices are set out in Schedule 1.
Part 3—Conformity assessment procedures
Division 3.1—Medical device classifications
3.1 Medical device classifications (Act s 41DB)
(1) For section 41DB of the Act, the following table specifies the medical device classifications.
| Item | Medical device | Class | Class | Class | Class | Class |
| 1 | Medical devices other than IVD medical devices | I | IIa | IIb | III | AIMD |
| 2 | IVD medical devices and in‑house IVD medical devices | 1 | 2 | 3 | 4 | |
(2) In the table:
(a) the lowest level of medical device classification is specified in column 3; and
(b) successively higher levels of classification are specified in columns 4 to 6; and
(c) columns 6 and 7 are of equal classification; and
(d) a device specified in a column has the same level of classification as any other device specified in that column.
3.2 Classification of medical devices
(1) A medical device, other than an IVD medical device, has the medical device classification applying under the classification rules set out in Schedule 2.
(2) An IVD medical device has the medical device classification applying under the classification rules set out in Schedule 2A.
3.3 Principles for applying the classification rules
(1) For the purpose of classifying a medical device, the principles set out in this regulation apply.
(2) A medical device is classified as follows:
(a) if the medical device is a medical device other than an IVD medical device—having regard to the intended purpose of the device;
(b) if the medical device is an IVD medical device or an in‑house IVD medical device—having regard to the intended purpose of the device in accordance with the following risk classes:
(i) Class 1 IVD medical device or Class 1 in‑house IVD medical device—no public health risk or low personal risk;
(ii) Class 2 IVD medical device or Class 2 in‑house IVD medical device—low public health risk or moderate personal risk;
(iii) Class 3 IVD medical device or Class 3 in‑house IVD medical device—moderate public health risk or high personal risk;
(iv) Class 4 IVD medical device or Class 4 in‑house IVD medical device—high public health risk.
(3) If a medical device is designed to be used in combination with another medical device, each of the devices is classified separately.
(4) An accessory to a medical device is classified separately from the medical device.
(5) If a medical device is driven, or influenced, by an item of software, the software has the same classification as the medical device.
(6) If a medical device is not designed to be used solely or principally in a specific part of a patient’s body, the medical device is classified having regard to the most critical specified use of the medical device.
(7) If, based on the intended purpose of the device, 2 or more classification rules apply to the medical device, the device has the highest level of classification applying under the applicable classification rules.
(8) For classification of a medical device system or a medical device procedure pack, medicines are not considered to be integral to the system or the procedure pack.
(9) For a system or procedure pack that contains both the devices mentioned in subregulation (11), that have different levels of classification under the table in regulation 3.1, the classification level of the system or procedure pack is that of the highest class of device mentioned in subregulation (11).
(10) A system or procedure pack that contains both of the devices mentioned in subregulation (11), that have the same level of classification under the table in regulation 3.1, is classified according to its primary intended purpose.
(11) For subregulations (9) and (10), the devices are:
(a) an IVD medical device; and
(b) a medical device that is not an IVD medical device.
Division 3.2—Conformity assessment procedures
3.4 Conformity assessment procedures (Act s 41DA)
(1) For section 41DA of the Act, the requirements relating to the obligations of manufacturers of medical devices (the conformity assessment procedures) are set out in Schedule 3.
(2) The application of the conformity assessment procedures to a medical device, or a kind of medical device, is set out in this Division.
(3) Subregulation (4) applies to the following devices:
(a) Class IIb medical devices;
(b) Class 3 IVD medical devices;
(c) Class IIa medical devices;
(d) Class 2 IVD medical devices;
(e) Class I medical devices;
(f) Class 1 IVD medical devices.
(4) The manufacturer of a device mentioned in subregulation (3) must apply to the device appropriate conformity assessment procedures, being:
(a) the minimum conformity assessment procedures that are applicable, under this Division, to the device; or
(b) if the manufacturer prefers, conformity assessment procedures that are applicable, under this Division, to a medical device that is classified at a higher level than the device concerned.
3.5 Powers and functions of Secretary in relation to conformity assessment
(1) For the purpose of applying conformity assessment procedures to a kind of medical device, a power or function of the Secretary, in relation to an assessment to be conducted under the procedures, may be exercised or performed at the place where the manufacturer is located, and at the manufacturing site, by a body or authority that the Secretary is satisfied has the authority and expertise to exercise that power or perform that function.
(2) If, under the conformity assessment procedures, the manufacturer of the kind of medical device is required to give information of a kind mentioned in paragraph 41MP(2)(a) or (b) of the Act to the Secretary, the information must be given to the Secretary in addition to any such information that is given to the body or authority mentioned in subregulation (1).
3.6 Class III medical devices and Class AIMD medical devices (other than medical devices used for a special purpose)
(1) Subject to subregulation (2), the conformity assessment procedures that must be applied to a Class III medical device, or a Class AIMD medical device, (other than a medical device used for a special purpose) are, as the manufacturer prefers:
(a) the full quality assurance procedures; or
(b) the type examination procedures and:
(i) the verification procedures; or
(ii) the production quality assurance procedures.
(2) If the device is intended by the manufacturer to be supplied in a sterile state, the conformity assessment procedures that must be applied to the device are, as the manufacturer prefers:
(a) the full quality assurance procedures; or
(b) the type examination procedures and the production quality assurance procedures.
3.6A Class 4 IVD medical devices (other than medical devices to be used for a special purpose)
The conformity assessment procedures that must be applied to a Class 4 IVD medical device (other than a medical device to be used for a special purpose) are, as the manufacturer prefers:
(a) the full quality assurance procedures; or
(b) the type examination procedures and the production quality assurance procedures.
3.6B Class 4 in‑house IVD medical devices (other than medical devices to be used for a special purpose)
The conformity assessment procedures that must be applied to a Class 4 in‑house IVD medical device (other than a medical device to be used for a special purpose) are, as the manufacturer prefers:
(a) the full quality assurance procedures; or
(b) the conformity assessment procedures set out in Part 6B of Schedule 3.
3.7 Class IIb medical devices (other than medical devices used for a special purpose)
(1) Subject to subregulation (2), the minimum conformity assessment procedures that must be applied to a Class IIb medical device (other than a medical device used for a special purpose) are, as the manufacturer prefers:
(a) the full quality assurance procedures (other than clause 1.6); or
(b) the type examination procedures and:
(i) the verification procedures; or
(ii) the production quality assurance procedures; or
(iii) the product quality assurance procedures.
(2) If the device is intended by the manufacturer to be supplied in a sterile state, the minimum conformity assessment procedures that must be applied to the device are, as the manufacturer prefers:
(a) the full quality assurance procedures (other than clause 1.6); or
(b) the type examination procedures and the production quality assurance procedures.
Note: The manufacturer of a Class IIb medical device (other than a medical device used for a special purpose) may prefer to apply to the device the conformity assessment procedures that must be applied to a medical device that is classified at a higher level—see subregulation 3.4(3).
3.7A Class 3 IVD medical devices (other than devices to be used for a special purpose)
The minimum conformity assessment procedures that must be applied to a Class 3 IVD medical device, other than a device to be used for a special purpose, are, as the manufacturer prefers:
(a) the full quality assurance procedures, other than clause 1.6 of Schedule 3; or
(b) the type examination procedures and the production quality assurance procedures.
Note: The manufacturer of a Class 3 IVD medical device may prefer to apply to the device the conformity assessment procedures that must be applied to an IVD medical device that is classified at a higher level—see subregulation 3.4(3).
3.7B Class 3 in‑house IVD medical devices
The conformity assessment procedures that must be applied to a Class 3 in‑house IVD medical device are the procedures mentioned in Part 6A of Schedule 3.
3.8 Class IIa medical devices (other than medical devices used for a special purpose)
(1) Subject to subregulation (2), the minimum conformity assessment procedures that must be applied to a Class IIa medical device (other than a medical device used for a special purpose) are, as the manufacturer prefers:
(a) the full quality assurance procedures (other than clause 1.6); or
(b) the declaration of conformity (not requiring assessment by Secretary) procedures and:
(i) the verification procedures (other than clause 3.5); or
(ii) the production quality assurance procedures (other than clause 4.7); or
(iii) the product quality assurance procedures (other than clause 5.7).
(2) If the device is intended by the manufacturer to be supplied in a sterile state, the minimum conformity assessment procedures that must be applied to the device are, as the manufacturer prefers:
(a) the full quality assurance procedures (other than clause 1.6); or
(b) the production quality assurance procedures (other than clause 4.7) and the declaration of conformity (not requiring assessment by Secretary) procedures.
Note: The manufacturer of a Class IIa medical device (other than a medical device used for a special purpose) may prefer to apply to the device the conformity assessment procedures that must or may be applied to a medical device that is classified at a higher level—see subregulation 3.4(3).
3.8A Class 2 IVD medical devices (other than devices to be used for a special purpose)
The minimum conformity assessment procedures that must be applied to a Class 2 IVD medical device, other than a device to be used for a special purpose, are, as the manufacturer prefers:
(a) the full quality assurance procedures, other than clause 1.6 of Schedule 3; or
(b) the declaration of conformity (not requiring assessment by Secretary) procedures and the production quality assurance procedures, other than clause 4.7 of Schedule 3.
Note: The manufacturer of a Class 2 IVD medical device may prefer to apply to the device the conformity assessment procedures that must be applied to an IVD medical device that is classified at a higher level—see subregulation 3.4(3).
3.8B Class 2 in‑house IVD medical devices
The conformity assessment procedures that must be applied to a Class 2 in‑house IVD medical device are the procedures mentioned in Part 6A of Schedule 3.
3.9 Class I medical devices (other than medical devices used for a special purpose)
(1) Subject to subregulations (2) and (3), the minimum conformity assessment procedures that must be applied to a Class I medical device (other than a medical device used for a special purpose) are the declaration of conformity (not requiring assessment by Secretary) procedures.
(2) If the device is intended by the manufacturer to be supplied in a sterile state, and the manufacturer applies the declaration of conformity (not requiring assessment by Secretary) procedures to the device, the production quality assurance procedures (other than clause 4.7) must also be applied to the device.
(3) If the device has a measuring function, and the manufacturer applies the declaration of conformity (not requiring assessment by Secretary) procedures, one of the following sets of procedures, as the manufacturer prefers, must also be applied to the device:
(a) the verification procedures (other than clause 3.5);
(b) the production quality assurance procedures (other than clause 4.7);
(c) the product quality assurance procedures (other than clause 5.7).
Note: The manufacturer of a Class I medical device (other than a medical device used for a special purpose) may prefer to apply to the device the conformity assessment procedures that must be applied to a medical device that is classified at a higher level—see subregulation 3.4(3).
3.9A Class 1 IVD medical devices (other than devices to be used for a special purpose)
The minimum conformity assessment procedures that must be applied to a Class 1 IVD medical device, other than a device to be used for a special purpose, are the declaration of conformity (not requiring assessment by Secretary) procedures.
Note: The manufacturer of a Class 1 IVD medical device may prefer to apply to the device the conformity assessment procedures that must be applied to an IVD medical device that is classified at a higher level—see subregulation 3.4(3).
3.9B Class 1 in‑house IVD medical devices
The conformity assessment procedures that must be applied to a Class 1 in‑house IVD medical device are the procedures mentioned in Part 6A of Schedule 3.
3.10 Medical devices used for a special purpose
(1) This regulation applies to the following kinds of medical devices (medical devices used for a special purpose):
(a) an exempt device;
(b) a medical device that is the subject of an approval under section 41HB of the Act;
(c) a medical device that is the subject of an authority under section 41HC of the Act;
(d) a system or procedure pack to which subregulation (3) applies;
(e) a system or procedure pack that contains at least 1 medical device, that is not an IVD medical device, and at least 1 IVD medical device.
Note for paragraph (a): An exempt device is a medical device of a kind that is exempted from the operation of Division 3 of Part 4‑11 of the Act by the regulations (see subsection 3(1) of the Act). Division 7.1 and Schedule 4 of these Regulations deal with exempt devices.
Note for paragraph (d): A system or procedure pack is treated as a single medical device. If paragraph (1)(e) or subregulation (3) does not apply to a system or procedure pack:
(a) the system or procedure pack is classified in accordance with Division 3.1 and either Schedule 2 or Schedule 2A; and
(b) the conformity assessment procedures that must be applied to the system or procedure pack are the procedures that apply to the relevant classification.
Note for paragraph (e): A system or procedure pack that contains both a medical device (that is not an IVD medical device) and an IVD medical device is treated as a single medical device. For the system or procedure pack:
(a) the system or procedure pack is classified in accordance with Division 3.1 and either Schedule 2 or Schedule 2A; and
(b) the conformity assessment procedures that must be applied to the system or procedure pack are the procedures for medical devices used for a special purpose in clause 7.5 of Schedule 3.
(1A) Despite subregulation (1), this regulation does not apply to Class 1 in‑house IVD medical devices, Class 2 in‑house IVD medical devices or Class 3 in‑house IVD medical devices.
Note: The conformity assessment procedures that must be applied to Class 1 in‑house IVD medical devices, Class 2 in‑house IVD medical devices or Class 3 in‑house IVD medical devices are the procedures mentioned in Part 6A of Schedule 3.
(2) The conformity assessment procedures that must be applied to a medical device used for a special purpose are the procedures for medical devices used for a special purpose.
(3) This subregulation applies to a system or procedure pack:
(a) that contains only one or more of the following:
(i) a medical device, or devices, to which the relevant conformity assessment procedures have been applied;
(ii) a medicine or medicines, a biological or biologicals, or other therapeutic goods, that are entered on the Register;
(iii) any other item or items that are not therapeutic goods when in the package; and
(b) that has been put together in accordance with the intended purpose of each medical device and the approved indications for use of each medicine, biological and other therapeutic goods; and
(c) the contents of which are compatible, having regard to the intended purpose of each medical device, the approved indications for use of each medicine, biological or other therapeutic goods, and the intended purpose of the system or procedure pack.
(4) If a system or procedure pack is intended by the manufacturer to be supplied in a sterile state, the production quality assurance procedures (other than clause 4.7) must also be applied to the system or procedure pack in relation to the aspects of the manufacturing process that relate to ensuring that the system or procedure pack is supplied and maintained in a sterile state.
Note: If the package contains a medicine, the manufacturer of the system or procedure pack must ensure that the method to be used for sterilisation or resterilisation is appropriate or is in accordance with the approved indications for use of the medicine.
3.11 Medical devices to which the clinical evaluation procedures must be applied
(1) Subject to subregulation (2), in addition to the conformity assessment procedures that are applied to a medical device in accordance with another regulation in this Division, the clinical evaluation procedures must also be applied to the device, for the purpose of demonstrating that the device complies with the applicable provisions of the essential principles, in particular:
(a) clause 1 of Schedule 1 (identification of the benefits and risks associated with the use of the device); and
(b) clause 3 of Schedule 1 (use of the device for its intended purpose); and
(c) clause 6 of Schedule 1 (acceptability of any side effects associated with the use of the device).
(2) This regulation does not apply to any of the following:
(a) an exempt device (other than an exempt device of a kind described in item 1.3 or 1.5 of Schedule 4);
(b) a medical device that is the subject of an approval under section 41HB of the Act;
(c) a medical device that is the subject of an authority under section 41HC of the Act.
3.12 Records to be provided in English
All records (including correspondence) provided by the manufacturer of a medical device in relation to the application of the conformity assessment procedures to the device must be in English.
3.13 Assessment or verification at intermediate stage of manufacture
(1) At the request of a person, and on payment of the prescribed fee, the Secretary may arrange for assessment or verification procedures to be carried out in relation to the application of the conformity assessment procedures to an article that is intended to be used in the manufacture of a medical device.
(2) A request may be made:
(a) at any stage of the manufacturing process; and
(b) whether or not an application has been made in relation to the article:
(i) for a conformity assessment certificate in respect of a medical device; or
(ii) for inclusion of a kind of medical device in the Register.
Part 4—Conformity assessment certificates
Division 4.1—Issuing conformity assessment certificates
4.1 When conformity assessment certificates are required (Act s 41EA)
For paragraph 41EA(b) of the Act, the kinds of medical devices in respect of which a conformity assessment certificate must be issued before a valid application can be made for those kinds of medical devices to be included in the Register, are medical devices that are of the following kinds:
(a) medical devices, other than IVD medical devices, that contain tissues of animal origin that have been rendered non‑viable (other than those that are intended to come into contact with intact skin only);
(b) medical devices, other than IVD medical devices, that contain tissues, cells or substances of microbial or recombinant origin and are intended for use in or on the human body;
(c) medical devices, other than IVD medical devices, incorporating stable derivatives of human blood or human plasma that are liable to act on the human body in a way that is ancillary to the device;
(d) medical devices, other than IVD medical devices, that incorporate, or are intended to incorporate, as an integral part, a substance that, if used separately, might be considered to be a medicine that is intended to act on a patient in a way that is ancillary to the device;
(e) Class 4 IVD medical devices;
(f) Class 4 in‑house IVD medical devices (other than those to which the conformity assessment procedures set out in Part 6B of Schedule 3 are applied).
4.2 Considering applications for conformity assessment certificates (Act s 41EC)
For subsection 41EC(2) of the Act, the following other requirements of the conformity assessment procedures are specified:
(a) the applicable requirements in relation to the establishment and maintenance of a post‑market monitoring, reporting and corrective action system;
(b) the applicable requirements in relation to the keeping of records.
4.3 Time for making decision on applications (Act s 41ED, s 63(2)(dc))
(1) This regulation applies to an application for the issue of a conformity assessment certificate in respect of a kind of medical device if, in considering the application, the Secretary is required to examine the design of the device.
(2) The Secretary must make a decision on the application within 255 working days after the application is received at an office of the Department specified by the Secretary.
(3) For subregulation (2), a working day that occurs in any of the following periods is to be disregarded:
(a) if the Secretary sends a query, or a request for information, to the applicant or sponsor—the period beginning on the day when the query or request is sent and ending at the end of the day when the Secretary receives from the applicant or sponsor a response that enables the Secretary to proceed with the assessment;
(b) if an appeal is lodged in relation to the application—the period beginning on the day when the appeal is lodged and ending at the end of the day when the appeal is finally determined;
(c) any other period in relation to which the applicant or sponsor agrees in writing for the purposes of this subregulation.
Division 4.1A—Conformity assessment (priority applicant) determinations
4.3A Application of Division
For the purposes of subsection 41ECA(1) of the Act, this Subdivision makes provision for and in relation to the making of conformity assessment (priority applicant) determinations.
4.3B Application for conformity assessment (priority applicant) determination
(1) A person may apply to the Secretary for a conformity assessment (priority applicant) determination in relation to a medical device.
(2) An application under subregulation (1) must:
(a) be in writing; and
(b) be in a form approved, in writing, by the Secretary; and
(c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.
(3) An application under subregulation (1) is taken not to have been made unless:
(a) the application meets the requirements in subregulation (2); and
(b) the fee prescribed in item 1.1A of Part 1 of Schedule 5 for making the application has been paid.
4.3C Making of conformity assessment (priority applicant) determination
(1) On receiving an application under subregulation 4.3B(1) for a conformity assessment (priority applicant) determination in relation to a medical device, the Secretary must:
(a) consider the application; and
(b) decide either:
(i) to make the determination; or
(ii) to refuse to make the determination.
Criteria
(2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medical device (the new device):
(a) the intended purpose of the new device is the monitoring, treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;
(b) either:
(i) no medical devices with that intended purpose are of a kind included in the Register; or
(ii) if one or more medical devices with that intended purpose are of a kind included in the Register (the existing devices)—there is substantial evidence demonstrating that the safety or performance of the new device when used for that intended purpose provides a significant improvement compared to the existing devices;
(c) at least one of the following applies to the new device:
(i) the new device is a breakthrough technology and there is evidence that it offers a major clinical advantage over existing technology;
(ii) there is evidence that the new device offers a major clinical advantage over existing alternatives included in the Register;
(iii) the new device is an IVD medical device and its early availability in Australia will result in a major public health benefit.
Information to be specified in determination
(3) The determination must specify:
(a) the person who, as a result of section 41ECA of the Act, is the priority applicant; and
(b) the medical device to which the determination relates; and
(c) the intended purpose of the medical device.
Notification of decision
(4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.
(5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.
4.3D Period during which conformity assessment (priority applicant) determination is in force
(1) A conformity assessment (priority applicant) determination in relation to a medical device:
(a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 4.3C(4); and
(b) subject to subregulation (2) and regulation 4.3E, remains in force for 6 months.
(2) If the priority applicant specified in the determination makes an effective application under section 41EB of the Act for a conformity assessment certificate that covers the medical device before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:
(a) the priority applicant withdraws the application; or
(b) the application lapses in accordance with section 41EG of the Act; or
(c) the application is finally determined.
Note: See subsection 41EB(2) of the Act for when an application under section 41EB of the Act is effective.
4.3E Revocation of conformity assessment (priority applicant) determination
(1) The Secretary may revoke a conformity assessment (priority applicant) determination in relation to a medical device if:
(a) either:
(i) the priority applicant specified in the determination has not made an application under section 41EB of the Act for a conformity assessment certificate that covers the medical device; or
(ii) the priority applicant has made such an application, but the application is not effective; and
(b) the Secretary is satisfied that the criteria specified in subregulation 4.3C(2) are no longer satisfied in relation to the medical device.
Note: See subsection 41EB(2) of the Act for when an application under section 41EB of the Act is effective.
(2) The revocation must be by written notice given by the Secretary to the priority applicant.
Division 4.1B—Content of conformity assessment certificates
4.3F Content of conformity assessment certificates
For the purposes of subsection 41EE(3) of the Act, the information is all of the following:
(a) a unique identification number for the certificate;
(b) the day on which the certificate is issued;
(c) the name and address of the manufacturer of the medical devices;
(d) the conformity assessment procedures applied to the medical devices by the manufacturer;
(e) if the certificate covers a medical device to which paragraph 1.6(a), (b) or (c) applies—the unique product identifier given to the device by the manufacturer;
(f) the conditions to which the certificate is subject under section 41EJ or 41EK of the Act;
(g) if one or more conformity assessment certificates have previously been issued in respect of the medical devices—the day on which each of those certificates was issued;
(h) the signature and name of the person issuing the certificate.
Division 4.1C—Conditions
4.3G Conditions applying automatically—information about poisons
(1) This regulation applies to a conformity assessment certificate that covers a kind of medical device that contains a substance of a kind covered by an entry in a Schedule to the current Poisons Standard.
(2) However, this regulation does not apply to the certificate if, under Appendix A to the current Poisons Standard, the Standard does not apply to poisons in that kind of device.
(3) For the purposes of subsection 41EJ(5A) of the Act, the certificate is subject to the condition that the manufacturer in respect of whom the certificate is issued will not supply a medical device of that kind if the supply would contravene Part 2 of the current Poisons Standard.
Division 4.2—Suspension of conformity assessment certificates
4.4 Period for revocation of suspension (Act s 41EP, s 63(2)(db))
(1) This regulation applies to an application to the Secretary under paragraph 41EP(2)(a) of the Act to revoke the suspension of a conformity assessment certificate.
(2) The Secretary must make a decision on the application within 40 working days after the application is received at an office of the Department specified by the Secretary.
Division 4.3—Transfer of conformity assessment certificates
4.5 Application of Division 4.3
This Division applies in relation to a manufacturer of a medical device in respect of whom a conformity assessment certificate is issued.
4.6 Death, bankruptcy or winding up of manufacturer
(1) If the manufacturer dies, the manufacturer’s legal personal representative:
(a) is taken to be the person in respect of whom the conformity assessment certificate is issued; and
(b) must notify the Secretary, in writing, of the death not later than 3 months after it occurred.
(2) If the manufacturer becomes bankrupt, the trustee in bankruptcy of the manufacturer’s estate:
(a) is taken to be the person in respect of whom the conformity assessment certificate is issued; and
(b) must notify the Secretary, in writing, of the manufacturer’s bankruptcy not later than 3 months after it occurred.
(3) If the manufacturer is a body corporate that is wound up, the liquidator of the body corporate:
(a) is taken to be the person in respect of whom the conformity assessment certificate is issued; and
(b) must notify the Secretary, in writing, of the winding up of the body corporate not later than 3 months after it occurred.
Note: See also regulations 4.10 and 4.11.
4.7 Disposal of business or amalgamation with another manufacturer
(1) This regulation applies if the name of the manufacturer is changed in any of the following circumstances:
(a) the manufacturer agrees to dispose of a business concerned with the manufacture of the medical device, and it is agreed that the disposal is to include a transfer of the conformity assessment certificate issued in respect of the manufacturer and the medical device;
(b) in the case of a manufacturer that is a body corporate—the manufacturer amalgamates with another body corporate under a name that is different from the name of the manufacturer on the conformity assessment certificate.
(2) The person to whom the business is disposed of, or the body corporate with whom the manufacturer amalgamates:
(a) is taken to be the person in respect of whom the conformity assessment certificate is issued; and
(b) must, not later than 3 months after the disposal or amalgamation, apply to the Secretary, in writing, for the name of the manufacturer to be changed on the conformity assessment certificate.
4.8 Change of name of manufacturer
If the name of the manufacturer is changed:
(a) the manufacturer, as renamed, is taken to be the person in respect of whom the conformity assessment certificate is issued; and
(b) the manufacturer must, not later than 3 months after the name is changed, notify the Secretary, in writing, of the new name and the circumstances in which the change occurred.
Note: See also regulations 4.10 and 4.11.
4.9 Effect of conformity assessment certificate after transfer, etc
If a conformity assessment certificate is taken to be issued in respect of a person because of the operation of regulation 4.6, 4.7 or 4.8:
(a) the certificate has effect as if it had actually been issued in respect of that person; and
(b) the medical devices to which the certificate relates may continue to be manufactured while the certificate is in effect.
4.10 Notification to Secretary of events
(1) If a person is required to notify the Secretary of an event under this Division, the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.
(2) If, at any time, the Secretary becomes aware that he or she has not been notified of an event as required by this Division, the Secretary may suspend or revoke the conformity assessment certificate to which the event relates.
4.11 Notification of change of name or suspension or revocation of conformity assessment certificate
(1) If, under this Division, the Secretary:
(a) changes the name of a manufacturer on a conformity assessment certificate; or
(b) suspends or revokes a conformity assessment certificate issued in respect of a manufacturer;
the Secretary must, as soon as practicable after changing the name or suspending or revoking the conformity assessment certificate:
(c) notify the manufacturer that the name has been changed or the conformity assessment certificate has been suspended or revoked; and
(d) ask the manufacturer to return to the Secretary the conformity assessment certificate that was given before the change of name or suspension or revocation.
(2) If a manufacturer receives a notice under subregulation (1), the manufacturer must return to the Secretary, as soon as practicable after receiving the notice, the conformity assessment certificate that was given before the change of name or suspension or revocation.
Penalty: 5 penalty units.
(3) An offence against subregulation (2) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
Part 4A—Australian conformity assessment bodies
Division 4A.1—Preliminary
4A.1 Purposes of this Part
(1) This Part (other than Division 4A.7) is made for the purposes of section 41EWA of the Act (about Australian conformity assessment bodies).
(2) Division 4A.7 is made for the purposes of section 41EWB of the Act (about the content of Australian conformity assessment body certificates).
Division 4A.2—Making conformity assessment body determinations
4A.2 Applications
(1) An Australian corporation may apply to the Secretary for a conformity assessment body determination in respect of the corporation.
(2) The application must:
(a) be made:
(i) in writing; and
(ii) in a form (if any) approved under subregulation (4); and
(iii) in a manner (if any) approved under subregulation (4); and
(b) be delivered to an office of the Department specified under subregulation (6).
(3) The application is not effective if:
(a) the application does not meet the requirements of subregulation (2) and regulation 4A.4; or
(b) the application contains information that is false or misleading in a material particular; or
(c) the application fee for the application has not been paid.
Note 1: For the application fee, see regulation 9.1 and Part 1 of Schedule 5.
Note 2: A conformity assessment body determination assessment fee is payable under Division 9.2 for assessment of the application.
Forms and manners
(4) For the purposes of subparagraph (2)(a)(ii) or (iii), the Secretary may, in writing, approve a form or manner for making an application for a conformity assessment body determination.
(5) The Secretary may approve different forms and manners for different classes of conformity assessment body determinations.
Offices
(6) For the purposes of paragraph (2)(b), the Secretary may, in writing, specify an office of the Department to which applications for conformity assessment bodies must be delivered.
(7) The Secretary may specify different offices for different classes of conformity assessment body determinations.
4A.3 Further information
(1) For the purposes of assessing an application for a conformity assessment body determination, the Secretary may, by written notice given to the applicant, require the applicant to deliver specified information or documents:
(a) to the office of the Department to which the application was delivered; and
(b) within the period, of not less than 10 working days after the day the notice is given, specified in the notice; and
(c) in a manner (if any) specified in the notice; and
(d) in accordance with regulation 4A.4.
(2) For the purposes of assessing an application for a conformity assessment body determination, the Secretary may:
(a) by written notice given to the applicant, require the applicant to allow an authorised person, at any reasonable time specified in the notice, to inspect specified premises (including premises outside Australia) that are or will be used by the applicant to carry on certification‑related activities; or
(b) by written notice given to a contractor of the applicant, require the contractor to allow an authorised person, at any reasonable time specified in the notice, to inspect specified premises (including premises outside Australia) that are or will be used by the contractor to carry on certification‑related activities for the applicant.
Note: For authorised person, see subsection 3(1) of the Act.
(3) If the Secretary gives a notice to a contractor under paragraph (2)(b), the Secretary must give a copy of the notice to the applicant.
4A.4 Documents to be provided in English
All documents (including correspondence) provided by an applicant in relation to an application for a conformity assessment body determination:
(a) must be provided in English; and
(b) may also be provided in any other language.
4A.5 Lapsing of applications
An application for a conformity assessment body determination lapses if:
(a) the applicant, or a contractor of the applicant, fails to comply with a notice under subregulation 4A.3(1) or (2) in relation to the application; or
(b) information given to the Secretary by, or on behalf of, the applicant in connection with the application, including information given for the purposes of a notice under subregulation 4A.3(1), is false or misleading in a material particular; or
(c) for the whole or a part of the conformity assessment body determination assessment fee for the application that is due and payable as mentioned in Division 9.2—the applicant fails to pay that whole or part in accordance with that Division.
4A.6 Assessing applications
(1) If an application is made in accordance with regulation 4A.2 for a conformity assessment body determination in respect of an Australian corporation, the Secretary must decide whether to make the conformity assessment body determination.
Conditions and criteria for making determinations
(2) The Secretary must not decide to make the determination unless he or she is satisfied that it is likely that the Australian corporation will be able to comply with the requirements of Schedule 3AA throughout the period specified in the determination as mentioned in paragraph 4A.8(2)(b).
(3) In deciding whether to make the conformity assessment body determination, the Secretary must also consider:
(a) whether at least one of the following persons:
(i) the Australian corporation;
(ii) a person (a manager) who makes, or participates in making, decisions that affect the whole, or a substantial part, of the Australian corporation’s affairs;
(iii) a major interest holder of the Australian corporation;
has, within the 10 years immediately before the application:
(iv) been convicted of an offence against the 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 the 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 body determination; or
(ix) had a conformity assessment body determination in respect of the person 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 years, if the conduct resulting in that subparagraph applying occurred when the person was a manager or major interest holder of the body corporate; and
(b) any other relevant matter.
(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) Nothing in this regulation 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).
(6) Subregulation (2) and paragraph (3)(a) do not limit paragraph (3)(b).
4A.7 Procedure following decisions to make determinations
(1) This regulation applies if the Secretary decides under subregulation 4A.6(1) to make a conformity assessment body determination in respect of an Australian corporation.
(2) The Secretary must notify the Australian corporation within 20 working days.
(3) When all conformity assessment body determination assessment fees that are due and payable for the application have been paid, the Secretary must:
(a) make the determination, including specifying:
(i) the scope of the determination in accordance with subregulation (4); and
(ii) the commencement and duration of the determination in accordance with regulation 4A.8; and
(b) give it to the corporation.
(4) The conformity assessment body determination must specify whether it:
(a) is of general application; or
(b) is limited to either or both of the following:
(i) one or more specified medical devices;
(ii) one or more specified conformity assessment procedures.
(5) The conformity assessment body determination may specify conditions to which it is subject.
Note: See regulation 4A.19.
4A.8 Duration of determinations
(1) A conformity assessment body determination commences on the day specified for the purpose in the determination under subparagraph 4A.7(3)(a)(ii).
(2) A conformity assessment body determination has effect at all times:
(a) unless the determination is suspended under Division 4A.4; or
(b) until the end of the period specified in the determination under subparagraph 4A.7(3)(a)(ii); or
(c) until the determination is revoked under Division 4A.5.
(3) The period specified in the determination as mentioned in paragraph (2)(b) must be 5 years or less, starting on the day the determination commences.
4A.9 Procedure following decisions not to make determinations
(1) This regulation applies if the Secretary decides under subregulation 4A.6(1) not to make a conformity assessment body determination in respect of an Australian corporation.
(2) The Secretary must notify the Australian corporation within 20 working days.
(3) The notice must state the reasons for the decision.
Division 4A.3—Conditions on conformity assessment body determinations
Subdivision A—Automatic conditions on determinations
4A.10 Automatic conditions on determinations
A conformity assessment body determination is subject to the conditions set out in this Subdivision.
Note: See sections 41MN and 41MNA of the Act for offences and civil penalty provisions that apply to breaching a condition of a conformity assessment body determination.
4A.11 Conditions—requirements of Schedule 3AA
The Australian conformity assessment body will comply with the requirements of Schedule 3AA.
4A.12 Conditions—notifying Secretary and clients
(1) The Australian conformity assessment body will notify the Secretary within 10 working days if there are any substantial changes relating to the body’s compliance with the requirements of Schedule 3AA.
(2) The Australian conformity assessment body will notify the Secretary and relevant clients of the body as soon as practicable if the body plans to cease carrying on one or more kinds of certification‑related activities relating to conformity assessment procedures covered by the determination.
(3) The notice under subregulation (2) must specify the day on which the body plans to cease carrying on the activity.
4A.13 Conditions—entry and inspection
(1) The Australian conformity assessment body will allow an authorised person:
(a) to enter, at any reasonable time, premises used by the body to carry on certification‑related activities; and
(b) while on those premises, to inspect those premises and anything on those premises that concerns certification‑related activities carried on by the body; and
(c) 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
(d) while on those premises, to inspect, and make copies of, any documents that concern certification‑related activities carried on by the body.
(2) The Australian conformity assessment body will have procedures, including a written agreement, in place with each contractor of the body that carries on certification‑related activities for the body that require the contractor to allow an authorised person:
(a) to enter, at any reasonable time, premises used by the contractor to carry on those certification‑related activities; and
(b) while on those premises, to inspect those premises and anything on those premises that concerns those certification‑related activities; and
(c) while on those premises, to make any still or moving image or any recording of those premises or anything on those premises that concerns those certification‑related activities; and
(d) while on those premises, to inspect, and make copies of, any documents that concern those certification‑related activities.
4A.14 Conditions—producing information and documents
(1) The Australian conformity assessment 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.
(2) The information will be given, or the documents produced, within the period, of not less than 20 working days after the day the notice is given, specified in the notice.
(3) The Australian conformity assessment body will have procedures, including a written agreement, in place with each of:
(a) its clients; and
(b) the contractors of the body that carry on certification‑related activities for the body;
that require the client or contractor to make available information or documents that the client or contractor has that is requested under subregulation (1).
4A.15 Conditions—reviews
The Australian conformity assessment body will cooperate in any review by the Secretary of:
(a) certification‑related activities carried on by the body; or
(b) compliance with the conditions of the conformity assessment body determination.
4A.16 Conditions—record keeping
The Australian conformity assessment body will keep:
(a) the records required by Schedule 3AA; and
(b) any other records necessary to demonstrate the body’s compliance, at all times while the determination is in effect, with the requirements of that Schedule.
4A.17 Conditions—Australian conformity assessment body certificates
Conformity assessment procedures
(1) The Australian conformity assessment body will not issue an Australian conformity assessment body certificate unless the body is satisfied that an appropriate conformity assessment procedure has been applied to medical devices of the kind covered by the certificate.
Varying, suspending and revoking certificates
(2) If the Australian conformity assessment body:
(a) issues an Australian conformity assessment body certificate to a manufacturer; and
(b) ceases to be satisfied that an appropriate conformity assessment procedure has been applied to medical devices of the kind covered by the certificate;
the body will:
(c) vary, suspend or revoke the certificate; or
(d) give to the manufacturer a written notice stating that the body will vary, suspend or revoke the certificate if the manufacturer does not, within a specified period, take the action necessary to satisfy the body that an appropriate conformity assessment procedure has been applied to the devices.
(3) A period specified in a notice under paragraph (2)(d) must be appropriate.
(4) The Australian conformity assessment body will vary, suspend or revoke an Australian conformity assessment body certificate if:
(a) the body gave a notice to a manufacturer under paragraph (2)(d) in relation to the certificate; and
(b) at the end of the period specified in the notice, the body is not satisfied that an appropriate conformity assessment procedure has been applied to medical devices of the kind covered by the certificate.
Notifying Secretary of changes to certificates and other matters
(5) The Australian conformity assessment body will notify the Secretary within 10 working days if the body:
(a) decides not to issue an Australian conformity assessment body certificate because the body is not satisfied as mentioned in subregulation (1); or
(b) suspends or revokes an Australian conformity assessment body certificate; or
(c) varies an Australian conformity assessment body certificate in the circumstances mentioned in subregulation (2) or (4); or
(d) becomes aware of a matter of significant concern relating to the safety of a medical device to which an Australian conformity assessment body certificate issued by the body applies.
4A.18 Conditions—clients
Notifying clients if determination varied or suspended
(1) The Australian conformity assessment body will notify its clients within 10 working days if the conformity assessment body determination is varied or suspended.
Agreements with successor Australian conformity assessment bodies
(2) If a client of the Australian conformity assessment body (the old body) informs the old body that the client plans:
(a) to cease to be a client of the old body; and
(b) to become a client of another Australian conformity assessment body (the new body);
the old body will enter into an agreement with the new body that deals appropriately with the transfer from the old body to the new body of responsibility for carrying on certification‑related activities for the client.
Enquiries before accepting applications for certification
(3) Before the Australian conformity assessment body accepts an application from a manufacturer to issue an Australian conformity assessment body certificate in relation to a kind of medical device, the body will make reasonable enquiries as to whether the manufacturer has applied to another Australian conformity assessment body to issue an Australian conformity assessment body certificate in relation to that kind of device.
Subdivision B—Conditions specified in conformity assessment body determinations
4A.19 Conditions specified in determinations
(1) A conformity assessment body determination is subject to any conditions specified in the determination under subregulation 4A.7(5) or 4A.28(1).
Note: See sections 41MN and 41MNA of the Act for offences and civil penalty provisions that apply to breaching a condition of a conformity assessment body determination.
(2) A condition imposed under subregulation 4A.7(5) or 4A.28(1) is in addition to the conditions imposed under Subdivision A of this Division.
Division 4A.4—Suspension of conformity assessment body determinations
4A.20 Suspension of determinations
(1) The Secretary may, by written notice given to an Australian conformity assessment body, suspend the body’s conformity assessment body determination if the Secretary is satisfied that:
(a) it is likely that there are grounds for revoking the determination under regulation 4A.27; and
(b) it is likely that the body will, within the period of the suspension, be able to take action such that it will no longer be likely that there are grounds for revoking the determination.
(2) The notice must specify the period of the suspension. The period:
(a) must not exceed 12 months; and
(b) must not begin before the notice is given to the body.
Note: The period of the suspension may be extended once under regulation 4A.22.
4A.21 Notice of proposed suspension
(1) However, before suspending a conformity assessment body determination, the Secretary must:
(a) notify the Australian conformity assessment body in writing that the Secretary proposes the suspension and set out the reasons for it; and
(b) give the body a reasonable opportunity to make submissions to the Secretary in relation to the proposed suspension.
(2) The Secretary must not make a decision relating to the proposed suspension until the Secretary has had regard to any submissions the body makes under paragraph (1)(b).
4A.22 Duration of suspension
(1) The suspension takes effect on the day specified for the purpose in the notice, which must be at least 20 working days after the notice is given to the Australian conformity assessment body.
(2) The suspension has effect until:
(a) the Secretary revokes it under regulation 4A.23; or
(b) the end of:
(i) the period specified in the notice under subregulation 4A.20(2); or
(ii) if the period is extended under subregulation (3) of this regulation—the period as so extended.
Note 1: The conditions to which the determination is subject continue during the suspension: see subsection 41EWA(7A) of the Act.
Note 2: Unless a suspension of a conformity assessment body determination has been revoked, the determination is automatically revoked at the end of the period of the suspension: see regulation 4A.25.
(3) The Secretary may, by written notice given to the body, extend the period specified in the notice under subregulation 4A.20(2) by a further specified period not exceeding 12 months if the Australian conformity assessment body shows that it has taken steps to address the grounds for revoking the determination under regulation 4A.27.
(4) Only one extension of the period of the suspension may be made.
4A.23 Revocation of suspension
(1) The Secretary must revoke the suspension if the Secretary is satisfied that:
(a) the grounds on which the conformity assessment body determination was suspended no longer apply; and
(b) there are no other grounds for suspending the determination.
(2) The Secretary’s power to revoke the suspension may be exercised:
(a) if the Australian conformity assessment body 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 Australian conformity assessment body.
(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.
4A.24 Powers of revocation of determinations unaffected
(1) This Division does not affect the Secretary’s powers to revoke a conformity assessment body determination under Division 4A.5.
(2) To the extent that a suspension under this Division relates to a conformity assessment body determination to which such a revocation relates, the suspension ceases to have effect.
Division 4A.5—Revocation of conformity assessment body determinations
4A.25 Automatic revocation of determinations
(1) The Secretary must, by written notice given to an Australian conformity assessment body, revoke the body’s conformity assessment body determination if:
(a) the determination has been suspended under Division 4A.4; and
(b) the period of the suspension under paragraph 4A.22(2)(b) ends before the suspension is revoked under regulation 4A.23.
(2) The revocation takes effect at the end of the period mentioned in paragraph (1)(b) of this regulation.
4A.26 Immediate revocation of determinations
(1) The Secretary may, by written notice given to an Australian conformity assessment body, revoke the body’s conformity assessment body determination if:
(a) the body applies in writing to the Secretary; or
(b) the body notifies the Secretary, as mentioned in subregulation 4A.12(2), that the body plans to cease carrying on certification‑related activities completely.
(2) The revocation takes effect on the day specified for the purpose in the notice given by the Secretary.
(3) If paragraph (1)(b) applies, the day specified in the notice given by the Secretary must be the day the Australian conformity assessment body notified the Secretary was the day the body planned to cease carrying on certification‑related activities.
4A.27 Revocation of determinations after notice of proposed revocation
(1) The Secretary may, by written notice given to an Australian conformity assessment body, revoke the body’s conformity assessment body determination if:
(a) the body refuses or fails to comply with a condition to which the determination is subject; or
(b) at least one of the following persons:
(i) the body;
(ii) a person (a manager) who makes, or participates in making, decisions that affect the whole, or a substantial part, of the body’s affairs;
(iii) a major interest holder of the body;
has:
(iv) been convicted of an offence against the 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 the 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 body determination; or
(ix) had a conformity assessment body determination in respect of the person 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.
(2) A reference in paragraph (1)(b) 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.
(3) Nothing in this regulation 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).
Notice of proposed revocation
(4) Before revoking a conformity assessment body determination under this regulation, the Secretary must:
(a) notify the Australian conformity assessment body in writing that the Secretary proposes the revocation and set out the reasons for it; and
(b) give the body a reasonable opportunity to make submissions to the Secretary in relation to the proposed revocation.
(5) The Secretary must not make a decision relating to the proposed revocation until the Secretary has had regard to any submissions the body makes under paragraph (4)(b).
When revocation takes effect
(6) A revocation under this regulation takes effect on the day specified for the purpose in the notice given to the Australian conformity assessment body under subregulation (1).
(7) The day specified must not be earlier than the day the notice is given to the body.
Division 4A.6—Variation of conformity assessment body determinations
4A.28 Imposing, varying or removing conditions
(1) The Secretary may, by written notice given to an Australian conformity assessment body, vary the body’s conformity assessment body determination to:
(a) impose new conditions on the determination; or
(b) vary or remove existing conditions imposed on the determination under subregulation 4A.7(5) or this regulation.
(2) The Secretary’s power under subregulation (1) may be exercised:
(a) if the Australian conformity assessment body applies in writing to the Secretary; or
(b) on the Secretary’s own initiative.
When imposition, variation or removal takes effect
(3) An imposition or variation of a condition under this regulation takes effect on the day specified for the purpose in the notice.
(4) The day specified in the notice under subregulation (3) must be at least 20 working days after the notice is given to the body, unless the body:
(a) applied for the imposition or variation; and
(b) has agreed to an earlier day.
(5) A removal of a condition under this regulation takes effect on the day specified in the notice.
(6) The day specified in the notice under subregulation (5) must be at least 20 working days after the notice is given to the body, unless the body has agreed to an earlier day.
(7) For the purposes of subregulations (4) and (6), the earlier day must not be earlier than the day the notice is given to the body.
4A.29 Limiting determinations
(1) The Secretary may, by written notice given to an Australian conformity assessment body, vary the body’s conformity assessment body determination to limit, or further limit, the determination as mentioned in paragraph 4A.7(4)(b).
(2) The Secretary’s power under subregulation (1) of this regulation may be exercised:
(a) if the Australian conformity assessment body applies in writing to the Secretary; or
(b) on the Secretary’s own initiative.
(3) A variation under this regulation takes effect on the day specified for the purpose in the notice.
(4) The day specified in the notice under subregulation (3) must be at least 20 working days after the notice is given to the body, unless the body:
(a) applied for the variation; and
(b) has agreed to an earlier day.
(5) For the purposes of subregulation (4), the earlier day must not be earlier than the day the notice is given to the body.
4A.30 Notice of proposed variation
(1) Before varying a conformity assessment body determination under this Division, the Secretary must:
(a) notify the Australian conformity assessment body in writing that the Secretary proposes the variation and set out the reasons for it; and
(b) give the body a reasonable opportunity to make submissions to the Secretary in relation to the proposed variation.
(2) The Secretary must not make a decision relating to the proposed variation until the Secretary has had regard to any submissions the body makes under paragraph (1)(b).
(3) This regulation does not apply if the body applied for the variation.
Division 4A.7—Australian conformity assessment body certificates
4A.31 Content of Australian conformity assessment body certificates
For the purposes of subsection 41EWB(2) of the Act, the information is all of the following:
(a) the name and address of the body issuing the certificate;
(b) the body’s ACN (within the meaning of the Corporations Act 2001);
(c) the unique identification number assigned to the body under subsection 41EWA(4A) of the Act;
(d) a unique identification number for the certificate;
(e) the day on which the certificate is issued;
(f) the name and address of the manufacturer of the medical devices;
(g) the conformity assessment procedures applied to the medical devices by the manufacturer;
(h) if the certificate covers a medical device to which paragraph 1.6(a), (b) or (c) applies—the unique product identifier given to the device by the manufacturer;
(i) if the certificate is varied—the day and details of the variation;
(j) if one or more Australian conformity assessment body certificates have previously been issued in respect of the medical devices by the body—the information covered by paragraphs (a) to (i) in relation to each of those certificates.
Part 5—Including medical devices in the Register
Division 5.1—Including medical devices in the Register
Note: Regulation 5.1 is intentionally not used.
Subdivision A—Applications
5.2 Matters to be certified—period for obtaining information from manufacturer (Act s 41FD)
For subparagraphs 41FD(e)(ii) and (g)(ii) of the Act, the period is 20 working days.
Subdivision C—Auditing of applications
5.3 Selecting applications for auditing (Act s 41FH)
(1) For paragraph 41FH(1)(a) of the Act and subject to subregulation (2) or (2A), an application for any of the following kinds of medical devices to be included in the Register is prescribed:
(a) a medical device (other than a condom) that is a barrier indicated for contraception or prevention of the transmission of disease in the course of penile penetration during sexual intercourse;
(b) a medical device that is an implantable contraceptive device;
(d) a medical device of a kind described in subclause 5.3(2) of Schedule 2;
Note: Subclause 5.3(2) of Schedule 2 applies to a medical device that is specifically intended by the manufacturer to be used for disinfecting another medical device.
(e) a Class AIMD medical device;
(g) a medical device that is an implantable intra‑ocular lens;
(h) a medical device that is an intra‑ocular visco‑elastic fluid;
(i) a Class III medical device that has not been assessed under the EC Mutual Recognition Agreement or the EFTA Mutual Recognition Agreement;
(j) any of the following IVD medical devices:
(i) non assay‑specific quality control material that is intended for monitoring a Class 4 IVD medical device;
(ii) an IVD medical device that is intended for self‑testing;
(iii) an IVD medical device that is intended for point of care testing;
(iv) a Class 3 IVD medical device that is intended for detecting the presence of, or exposure to, a sexually transmitted agent;
(v) an IVD medical device for managing or monitoring the treatment of infections diagnosed using a Class 4 IVD medical device (for example, quantitative nucleic acid test (NAT) and genotyping assays for HIV and HCV);
(vi) an IVD medical device that is intended to be supplied for use under the pharmaceutical benefits scheme;
(vii) an IVD medical device that is intended to be supplied for use in a national screening program;
(viii) if the Secretary is not satisfied that a body or authority has the authority and expertise to exercise a power or perform a function of the Secretary mentioned in subregulation 3.5(1)—an IVD medical device that has been manufactured in a location and at a site where that body or authority has exercised such a power or performed such a function in relation to the device;
(ix) a Class 4 in‑house IVD medical device.
(2) Subregulation (1) does not apply to an application for a kind of medical device to be included in the Register if a conformity assessment certificate, or an Australian conformity assessment body certificate, has been issued, and has not been suspended or revoked, in respect of the kind of medical device.
(2A) Subregulation (1) does not apply to an application for a medical device that is covered by clause 5.8 of Schedule 2 or clause 1.8 of Schedule 2A.
Subdivision D—Miscellaneous—medical devices (priority applicant) determinations
5.4 Application of Subdivision
For the purposes of subsection 41FKA(1) of the Act, this Subdivision makes provision for and in relation to the making of medical devices (priority applicant) determinations.
5.4A Application for medical devices (priority applicant) determination
(1) A person may apply to the Secretary for a medical devices (priority applicant) determination in relation to a medical device.
(2) An application under subregulation (1) must:
(a) be in writing; and
(b) be in a form approved, in writing, by the Secretary; and
(c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.
(3) An application under subregulation (1) is taken not to have been made unless:
(a) the application meets the requirements in subregulation (2); and
(b) the fee prescribed in item 1.5A of Part 1 of Schedule 5 for making the application has been paid.
5.4B Making of medical devices (priority applicant) determination
(1) On receiving an application under subregulation 5.4A(1) for a medical devices (priority applicant) determination in relation to a medical device, the Secretary must:
(a) consider the application; and
(b) decide either:
(i) to make the determination; or
(ii) to refuse to make the determination.
Criteria
(2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medical device (the new device):
(a) the intended purpose of the new device is the monitoring, treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;
(b) either:
(i) no medical devices with that intended purpose are of a kind included in the Register; or
(ii) if one or more medical devices with that intended purpose are of a kind included in the Register (the existing devices)—there is substantial evidence demonstrating that the safety or performance of the new device when used for that intended purpose provides a significant improvement compared to the existing devices;
(c) at least one of the following applies to the new device:
(i) the new device is a breakthrough technology and there is evidence that it offers a major clinical advantage over existing technology;
(ii) there is evidence that the new device offers a major clinical advantage over existing alternatives included in the Register;
(iii) the new device is an IVD medical device and its early availability in Australia will result in a major public health benefit.
Information to be specified in determination
(3) The determination must specify:
(a) the person who, as a result of section 41FKA of the Act, is the priority applicant; and
(b) the medical device to which the determination relates; and
(c) the intended purpose of the medical device.
Notification of decision
(4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.
(5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.
5.4C Period during which medical devices (priority applicant) determination is in force
(1) A medical devices (priority applicant) determination in relation to a medical device:
(a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 5.4B(4); and
(b) subject to subregulation (2) and regulation 5.4D, remains in force for 6 months.
(2) If the priority applicant specified in the determination makes an application under section 41FC of the Act for that kind of medical device to be included in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:
(a) the priority applicant withdraws the application; or
(b) the application lapses in accordance with section 41FK of the Act; or
(c) the application is finally determined.
Note: See subsection 41FDB(3) of the Act for when an application passes preliminary assessment.
5.4D Revocation of medical devices (priority applicant) determination
(1) The Secretary may revoke a medical devices (priority applicant) determination in relation to a medical device if:
(a) either:
(i) the priority applicant specified in the determination has not made an application under section 41FC of the Act for that kind of medical device to be included in the Register; or
(ii) the priority applicant has made such an application, but the application does not pass preliminary assessment; and
(b) the Secretary is satisfied that the criteria specified in subregulation 5.4B(2) are no longer satisfied in relation to the medical device.
Note: See subsection 41FDB(3) of the Act for when an application passes preliminary assessment.
(2) The revocation must be by written notice given by the Secretary to the priority applicant.
Division 5.2—Conditions
Note: Regulation 5.5 is intentionally not used.
5.6 Conditions applying automatically—period for obtaining information from manufacturer (Act s 41FN)
For subparagraphs 41FN(3)(a)(ii) and (b)(iii) of the Act, the period is 20 working days.
5.7 Conditions applying automatically—period for giving information about adverse events etc (Act s 41FN)
(1) For paragraph 41FN(3)(d) of the Act, the period in which a person in relation to whom a kind of medical device is included in the Register must give information of a kind mentioned in subsection 41MP(2) of the Act to the Secretary is:
(a) if the information relates to an event or other occurrence that represents a serious threat to public health—48 hours after the person becomes aware of the event or occurrence; and
(b) if the information relates to an event or other occurrence that led to the death, or a serious deterioration in the state of health, of a patient, a user of the device, or another person—10 days after the person becomes aware of the event or occurrence; and
(c) if the information relates to an event or other occurrence a recurrence of which might lead to the death, or a serious deterioration in the state of health, of a patient, a user of the device, or another person—30 days after the person becomes aware of the event or occurrence.
(2) For paragraph (1)(a), an event or other occurrence, in relation to a kind of medical device, represents a serious threat to public health if:
(a) the event or other occurrence is a hazard arising from a systematic failure of the device that becomes known to the person in relation to whom the device is included in the Register; and
(b) the event or other occurrence may lead to the death of, or a serious injury to, a patient, a user of the device or another person; and
(c) the existence of, probable rate of occurrence of, or degree of severity of harm caused by, the hazard was not previously known or anticipated by the manufacturer of the device; and
(d) the manufacturer will be required to take prompt action to eliminate, or reduce the risk of, the hazard.
(3) For paragraphs (1)(b) and (c), an event or other occurrence leads to a serious deterioration in the state of health of a person if the event or other occurrence causes, or contributes to:
(a) a life‑threatening illness or injury suffered by the person; or
(b) a permanent impairment of a bodily function of the person; or
(c) permanent damage to a body structure of the person; or
(d) a condition requiring medical or surgical intervention to prevent such permanent impairment or damage.
5.8 Conditions applying automatically—requirements in relation to information about kind of medical device (Act s 41FN)
For subsection 41FN(4) of the Act, the information required for the purposes of paragraph 41FN(3)(e) of the Act in relation to a kind of medical device that is included in the Register in relation to a person is:
(a) any information that the person is aware of relating to:
(i) any malfunction or deterioration in the characteristics or performance of the kind of device; or
(ii) any inadequacy in the design, manufacture, 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 has led to any complaint or problem in relation to the kind of device, no matter how minor; and
(b) any information of the kind mentioned in subsection 41MP(2) of the Act that the person is aware of in relation to the kind of device.
5.9 Conditions applying automatically—storage and transport of medical devices (Act s 41FN)
For the purposes of subsection 41FN(5A) of the Act, the person in relation to whom a kind of medical device is included in the Register must ensure that, while the person has control over a device of that kind, the device is stored and transported in accordance with the manufacturer’s instructions for use of the device and any other information provided with the device by the manufacturer.
5.10 Conditions applying automatically—record‑keeping (Act s 41FN)
(1) For the purposes of subsection 41FN(5A) of the Act, the person in relation to whom a kind of medical device is included in the Register must:
(a) create a record of information of a kind referred to in regulation 5.8 that relates to that kind of device as soon as practicable after the person becomes aware of the information; and
(b) create a record of information in relation to the distribution by the person of each device of that kind as soon as practicable after the distribution.
(2) A record created under subregulation (1) must be kept:
(a) for 10 years if the record relates to one of the following kinds of device:
(i) a Class AIMD medical device;
(ii) a Class III medical device;
(iii) a Class IIb medical device that is an implantable medical device;
(iv) a Class 4 IVD medical device; or
(b) for 5 years if the record relates to any other kind of device.
5.11 Conditions applying automatically—reporting (Act s 41FN)
(1) This regulation applies in relation to the following kinds of medical devices:
(a) a Class AIMD medical device;
(b) a Class III medical device;
(c) a Class IIb medical device that is an implantable medical device;
(d) a Class 4 IVD medical device.
(2) For the purposes of subsection 41FN(5A) of the Act, the person in relation to whom a medical device of that kind is included in the Register must, before 1 October after each reporting period for that kind of device, give the Secretary a report about that kind of device for the reporting period.
(3) The report must include the following:
(a) if no device of that kind was supplied in Australia or a foreign country during the reporting period—a statement to that effect;
(b) if the person became aware during the reporting period of information of a kind referred to in regulation 5.8 that relates to that kind of device—that information;
(c) if the person did not become aware during the reporting period of information of a kind referred to in regulation 5.8 that relates to that kind of device—a statement to that effect.
(4) For the purposes of this regulation, each of the following is a reporting period for a kind of medical device:
(a) the period:
(i) beginning on the day when that kind of device is included in the Register; and
(ii) ending at the end of the next 30 June;
(b) each of the next 2 financial years.
5.12 Conditions applying automatically—notification of information relating to certain IVD medical devices (Act s 41FN)
(1) This regulation applies in relation to a kind of medical device specified in paragraph 5.3(1)(j).
(2) For the purposes of subsection 41FN(5A) of the Act, the person in relation to whom a medical device of that kind is included in the Register must give the Secretary a written notice if:
(a) the person intends to import, supply or export a medical device of that kind; and
(b) either of the following is not included in the Register:
(i) the product name of the device;
(ii) information in relation to the manufacturer’s intended purpose of the device.
(3) The notice must:
(a) specify the information mentioned in paragraph (2)(b) that is not included in the Register; and
(b) be given to the Secretary no later than 20 business days before the intended import, supply or export of the device.
5.13 Conditions applying automatically—information about poisons (Act s 41FN)
(1) This regulation applies in relation to a kind of medical device that contains a substance of a kind covered by an entry in a Schedule to the current Poisons Standard.
(2) However, this regulation does not apply in relation to that kind of medical device if, under Appendix A to the current Poisons Standard, the Standard does not apply to poisons in that kind of medical device.
(3) For the purposes of subsection 41FN(5A) of the Act, the person in relation to whom a medical device of that kind is included in the Register must not supply the device in Australia if the supply would contravene Part 2 of the current Poisons Standard.
Part 6—Suspension and cancellation from the Register
6.1 Period for revocation of suspension (Act s 41GD, s 63(2)(dd))
(1) This regulation applies to an application to the Secretary under paragraph 41GD(2)(a) of the Act to revoke the suspension of a kind of medical device from the Register.
(2) The Secretary must make a decision on the application within 40 working days after the application is received at an office of the Department specified by the Secretary.
Part 6A—Disposal of unused emergency medical devices
6A.1 Disposal of unused emergency medical devices
(1) For subsection 41GY(2) of the Act, the arrangements for disposal of unused emergency medical devices are set out in Schedule 3A.
(2) Nothing in this regulation or in Schedule 3A is taken to prevent a disposal of unused emergency medical devices if:
(a) the devices have become:
(i) devices of a kind included in the Register under Part 4‑5 of the Act; or
(ii) exempt devices under section 41HA of the Act; or
(iii) devices that are the subject of an approval under section 41HB of the Act; or
(iv) devices that are the subject of an authority under section 41HC of the Act; and
(b) the disposal is in accordance with other provisions of the Act and these Regulations relevant to the devices.
Part 7—Exempting medical devices from inclusion in the Register
Division 7.1—Exempt devices
7.1 Exempt devices—general (Act s 41HA)
(1) For paragraph 41HA(1)(b) of the Act, a kind of medical device mentioned in Part 1 of Schedule 4 is exempt from the operation of Division 3 of Part 4‑11 of the Act.
(2) For paragraph 41HA(1)(b) and subsection 41HA(2) of the Act, a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 is exempt from the operation of Division 3 of Part 4‑11 of the Act, subject to compliance with the conditions mentioned in column 3 of that item.
(3) If:
(a) a kind of medical device that is exempt from the operation of Division 3 of Part 4‑11 of the Act ceases to be so exempt; and
(b) an application was made for the kind of device to be included in the Register before the device ceased to be exempt;
the kind of device is taken to be exempt from the operation of Division 3 of Part 4‑11 of the Act until the application is determined.
7.2 Exempt devices—use in life‑threatening cases (Act s 41HA)
(1) For paragraph 41HA(1)(b) of the Act, and without limiting regulation 7.1, a kind of medical device is exempt from the operation of Division 3 of Part 4‑11 of the Act if:
(a) the kind of device is to be used in or on a person who is a Category A patient; and
(b) the following conditions are satisfied in relation to the use of the device:
(i) the person in or on whom the kind of device is to be used, or the person’s guardian, has given informed consent to the use of the device in or on the person;
(ii) a statement in relation to the person is completed in accordance with subregulation (1A);
(iii) the device is used in accordance with the direction of the medical practitioner who requested its use.
(1A) For the purposes of subparagraph (1)(b)(ii), a statement in relation to the use of an exempt device in or on a person who is a Category A patient must:
(a) be completed by:
(i) the medical practitioner by whom, or at whose direction, the device is used; or
(ii) by a health practitioner acting on behalf of that medical practitioner; and
(b) be in the form approved by the Secretary for the purposes of this paragraph; and
(c) include the following:
(i) the initial letters of the person’s given name and surname, and the person’s date of birth and sex;
(ii) the diagnosis of the person’s condition;
(iii) the expected duration of the treatment;
(iv) a description of the exempt device;
(v) the supplier of the exempt device;
(vi) the number of units of the exempt device to be supplied;
(vii) the treating medical practitioner’s name, practising address and other contact details; and
(d) include a statement to the effect that:
(i) the person is a Category A patient; and
(ii) the person, or the person’s guardian, has given informed consent to the use of the device in or on the person.
(1C) A person commits an offence of strict liability if the person:
(a) completes a statement referred to in subparagraph (1)(b)(ii); and
(b) does not send a copy of the statement to the Secretary within 28 days after the use of the exempt device to which the statement relates.
Penalty: 10 penalty units.
(2) In this regulation:
Category A patient means a person who is seriously ill with a condition that is reasonably likely to lead to the person’s death within less than a year or, without early treatment, to the person’s premature death.
informed consent, in relation to treatment or proposed treatment of a person, means consent to the treatment of the person that is freely given on the basis of information concerning the potential risks and benefits of the treatment that is sufficient to allow the person, or the person’s guardian, to make an informed decision about whether to consent to the treatment.
Division 7.2—Exemptions for experimental uses
7.3 Conditions of approval—use of device by person to whom approval is given (Act s 41HB)
(1) For subsection 41HB(3) of the Act, the conditions mentioned in this regulation apply to an approval granted to a person to use a kind of medical device solely for experimental purposes in humans.
(2) Before the commencement of any clinical trial proposed to be undertaken in relation to the device, the person to whom the approval is granted and the principal investigator of the clinical trial must give to the Secretary:
(a) a written assurance that each clinical trial will be conducted in accordance with the ‘National Statement on Ethical Conduct in Research Involving Humans’, published by the National Health and Medical Research Council, as in force from time to time; and
(b) a written undertaking:
(i) that the person will comply with any request by an authorised person, whether made before or after the commencement of a clinical trial, to give to the authorised person information about the conduct of the trial; and
(ii) that the person will allow an authorised person to do any of the things mentioned in regulation 7.4 in relation to a clinical trial.
7.4 Powers of authorised persons in relation to medical devices being used in clinical trials
(1) For subparagraph 7.3(2)(b)(ii) and subject to subregulation (2), an authorised person may do any of the following things in relation to a clinical trial of a kind of medical device that has been approved for use solely for experimental purposes in humans:
(a) enter the site of the trial;
(b) search the site and anything on the site;
(c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), anything on the site that relates to the trial;
(d) take photographs, make video recordings or make sketches of the site or anything on the site;
(e) inspect any book, record or other document on the site that relates to the trial;
(f) request the principal investigator of the trial to:
(i) answer any question asked by the authorised person; or
(ii) produce any book, record or other document requested by the authorised person.
(2) An authorised person is not entitled to do a thing mentioned in subregulation (1) if:
(a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised person to produce his or her identity card for inspection; and
(b) the authorised person fails to comply with the request.
Note: See section 52 of the Act in relation to identity cards.
(3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not obstruct the search.
(4) Subregulation (3) does not prevent 2 or more areas of the site being searched at the same time.
7.5 Conditions of approval—use of device by another person (Act s 41HB)
(1) For subsection 41HB(7) of the Act, the conditions mentioned in this regulation apply to the use by a person, for experimental purposes in humans, of a kind of medical device that is the subject of an approval granted to someone else under paragraph 41HB(1)(e) of the Act.
(2) The use of the device must comply with a procedural protocol approved by the ethics committee that is to be responsible for monitoring the conduct of the trial at each trial site (the responsible ethics committee).
(3) The use of the device must be in accordance with the ethical standards set out in the ‘National Statement on Ethical Conduct in Research Involving Humans’, published by the National Health and Medical Research Council, as in force from time to time.
(4) The person must cease using the device if the responsible ethics committee informs the principal investigator of the clinical trial that the use is inconsistent with:
(a) the protocol mentioned in subregulation (2); or
(b) any condition subject to which approval for the use was given.
Division 7.3—Exemptions for medical practitioners
7.6 Classes of medical practitioners and recipients (Act s 41HC)
(1) A class of medical practitioners prescribed for the purposes of paragraph 41HC(4)(a) of the Act is the class of medical practitioners each of whom is:
(a) a specialist medical practitioner who is engaged in clinical practice in a hospital and is endorsed by the ethics committee of the hospital; or
(b) a specialist medical practitioner who is engaged in treating patients outside a hospital and is endorsed by an ethics committee that:
(i) has expertise relating to the principal activities of the practitioner; or
(ii) conducts its activities within the geographic area where the medical practitioner is engaged in treating patients.
(2) A class of recipients prescribed for the purposes of paragraph 41HC(4)(c) of the Act is the class of recipients each of whom is a person who is suffering from a life‑threatening or otherwise serious illness or condition.
(3) For subsection 41HC(4) of the Act, each of the following is an exceptional circumstance in which paragraph 41HC(4)(b) of the Act does not apply:
(a) the Secretary is satisfied that the medical practitioner has no access to an ethics committee;
(b) the medical practitioner has an endorsement from a specialist college that does not have an ethics committee, but has expertise relevant to the treatment of the condition for which the authority is sought.
7.7 Circumstances for supply of device under authority (Act s 41HC)
For subsection 41HC(5) of the Act, a kind of medical device may be supplied under an authority under subsection 41HC(1) of the Act if the supplier of the device complies with the directions relating to the therapeutic intervention, or class of therapeutic intervention, mentioned in the authority.
7.8 Information to be notified in relation to supply of certain medical devices
For the purposes of paragraph 41HC(6C)(b) of the Act, the information that must be contained in a notification under subsection 41HC(6B) of the Act in relation to the supply by a health practitioner of a medical device to a person is as follows:
(a) the person’s initials, date of birth and gender;
(b) each medical condition in relation to which the device was supplied;
(c) each intended use of the device in relation to which the device was supplied;
(d) the product name of the device;
(e) the name of the manufacturer of the device;
(f) a brief description of the device including whether the device is a variant;
(g) the practitioner’s name, AHPRA number and contact details;
(h) the health profession in which the practitioner is registered or licensed to practise;
(i) the address of the practitioner’s principal place of practice.
Part 8—Obtaining information
8.1A Matters for which information and documents can be requested
For paragraph 41JA(1)(j) of the Act, the following matters are prescribed:
(a) whether the devices are medical devices;
(b) whether the devices are intended for a specified purpose, as ascertained under subsection 41BD(2) of the Act;
(c) whether the devices are correctly classified under Division 3.1 of Part 3;
(d) whether procedures are in place, including a written agreement with the manufacturer of the devices, that require the manufacturer to make available information mentioned in paragraph 41FD(e) or (g) of the Act;
(e) whether the devices contain substances that are prohibited imports under the Customs Act 1901;
(f) whether the devices are to be used exclusively for one or more of the purposes specified under section 41BEA of the Act;
(g) the accuracy and completeness of information included in or with the application;
(h) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of the Therapeutic Goods Regulations 1990 for exempting a person from liability to pay an annual charge for inclusion of the devices in the Register for a financial year, based on low value turnover of the devices;
(i) matters relating to an application to the Secretary under regulation 43AAH of the Therapeutic Goods Regulations 1990 to waive the annual charge for inclusion of the devices in the Register for a financial year;
(j) matters relating to:
(i) any malfunction or deterioration in the characteristics or performance of the devices; or
(ii) any inadequacy in the design, manufacture, labelling, instructions for use or advertising materials of the devices; or
(iii) any use in accordance with, or contrary to, the use intended by the manufacturer of the devices;
that has led to any complaint or problem in relation to the devices, no matter how minor;
(k) matters of the kind mentioned in subsection 41MP(2) of the Act;
(l) whether the devices comply with conditions to which the inclusion of the devices in the Register is subject;
(m) matters relating to the formulation of ingredients that constitute the devices.
8.1 Notice period (Act s 41JA)
For paragraph 41JA(2)(a) of the Act, the notice period for a kind of medical device in relation to which a person is required, by written notice given by the Secretary under subsection 41JA(1) of the Act, to give information to the Secretary is:
(a) if the information relates to manufacturing records—5 years; and
(b) if the information relates to distribution records:
(i) in the case of records relating to a Class AIMD medical device, Class III medical device, or Class IIb medical device that is an implantable medical device—10 years; and
(ii) in the case of records relating to any other device—5 years.
Part 9—Fees
Division 9.1—Fees
9.1 Fees
The following fees are prescribed:
(a) the fee mentioned in column 4 of an item in Part 1 of Schedule 5 in relation to the matter mentioned in column 2 of that item;
(b) the additional fees mentioned in Part 2 of Schedule 5.
Division 9.2—Conformity assessment body determination assessment fees
9.1A Purposes of this Division
This Division is made for the purposes of paragraph 41EWA(3)(g) of the Act.
9.1B Conformity assessment body determination assessment fees
(1) A fee is payable in relation to the assessment of an application for a conformity assessment body determination mentioned in column 2 of item 1.4D, 1.4E or 1.4F in Part 1 of Schedule 5.
(2) Subject to regulation 9.1C, the amount of the fee is the amount mentioned in column 4 of that item.
(3) The fee is payable by the applicant.
(4) Subject to regulation 9.1D, the fee is due and payable in full on the day specified under subregulation (5) of this regulation.
(5) For the purposes of subregulation (4), the Secretary may give the applicant a written notice specifying when the fee is due and payable in full.
9.1C Conformity assessment body determination assessment fees—abridged assessment
If the Secretary considers that he or she has sufficient information to allow assessment of an application for a conformity assessment body determination to be abridged:
(a) the Secretary may decide to conduct an abridged assessment of the application; and
(b) if the Secretary so decides—the Secretary may reduce the amount of the conformity assessment body determination assessment fee for assessment of the application.
9.1D Payment of conformity assessment body determination assessment fees by instalments
(1) The Secretary may approve, in relation to an application (the relevant application) for a conformity assessment body determination, the payment of a conformity assessment body determination assessment fee by instalments if:
(a) the applicant for the determination has applied in writing to pay the amount by instalments; and
(b) the amount payable exceeds $10,000; and
(c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if the amount is paid before the commencement of the assessment of the relevant application; and
(d) any information or material required under subregulation (3) has been given to the Secretary.
(2) An application under subregulation (1) must:
(a) state the reasons why paying the full amount of the fee before the assessment of the relevant application commences would cause financial hardship to the applicant; and
(b) have with it documents or other material in support of the application.
(3) The Secretary may reasonably require information or material in addition to the documents or material mentioned in paragraph (2)(b).
(4) If the Secretary approves an application for payment by instalments:
(a) half of the fee is due for payment before the commencement of the assessment of the relevant application; and
(b) one‑quarter of the fee is due for payment at the end of one month after the last day when the amount referred to in paragraph (a) may be paid; and
(c) the remaining one‑quarter of the fee is due for payment:
(i) if the relevant application is withdrawn—when the relevant application is withdrawn; and
(ii) in any other case—when the applicant is notified of the Secretary’s decision in respect of the relevant application under regulation 4A.7 or 4A.9.
(5) If the Secretary receives an application for payment by instalments, the Secretary must:
(a) within 30 days of receiving the application and any information or material required under subregulation (3), give notice, in writing, to the applicant stating whether the application has been approved; and
(b) if the application is approved—include with the notice information about the amount of each instalment and when it is due for payment.
(6) If:
(a) the Secretary approves an application for payment by instalments; and
(b) any amount of the instalment payable by the applicant is not paid when it becomes due for payment;
the balance of the fee becomes due for payment.
9.1E Recovery of conformity assessment body determination assessment fees
A conformity assessment body determination assessment fee may be recovered by the Commonwealth as a debt due to the Commonwealth.
9.1F Refund of conformity assessment body determination assessment fees if applications withdrawn
(1) The applicant for a conformity assessment body determination may apply to the Secretary, in writing, for a refund of the conformity assessment body determination assessment fee for the application if the applicant withdraws the application:
(a) after all or part of the fee becomes due and payable; and
(b) before the Secretary makes a decision on the application under subregulation 4A.6(1).
(2) Within 20 working days after receiving the application, the Secretary must:
(a) decide whether to refund any of the fee; and
(b) if so—the amount of the fee to be refunded.
(3) To avoid doubt, the applicant is not entitled to a refund of the application fee for the application.
Division 9.3—Assessment fees
9.2 Application audit assessment fee (Act ss 41LA, 41LB)
For section 41LB of the Act, an application audit assessment fee is due and payable 28 days after the day that the applicant is notified of the amount of the fee.
9.3 Conformity assessment fee (Act ss 41LA, 41LB)
(1) For section 41LB of the Act, and subject to subregulation (2), a conformity assessment fee for consideration of an application for a conformity assessment certificate is due and payable in full:
(a) on the day specified in a notice given to the applicant by the Secretary; or
(b) if the application is withdrawn before a decision is made in relation to the application and within the period mentioned in subregulation 4.3(2)—on the day when the application is withdrawn.
Note: See section 41LE of the Act in relation to the requirement to pay three‑quarters only of the conformity assessment fee in relation to certain kinds of applications.
(2) If:
(a) in accordance with section 41LE of the Act, an applicant has paid three‑quarters of the conformity assessment fee in relation to an application for a conformity assessment certificate; and
(b) the application is withdrawn before a decision is made in relation to the application and within the period mentioned in subregulation 4.3(2);
the part of the fee that is unpaid is due and payable on the day when the application is withdrawn.
(3) If the Secretary considers that additional assessment work is required in relation to an application for a conformity assessment certificate, the additional amount is due and payable on the day specified in a notice given to the applicant by the Secretary.
Note: The fee for any additional work is prescribed in item 1.12 of Schedule 5.
9.5 Payment of assessment fee by instalments (Act s 41LC)
(1) For section 41LC of the Act, the Secretary may, subject to subregulation (7), approve, in relation to a kind of medical device, the payment of an assessment fee by instalments if:
(a) the person who is liable to pay the fee (the applicant) has applied in writing to pay the amount by instalments; and
(b) the amount payable exceeds $10 000; and
(c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if the amount is paid before the commencement of the consideration or audit of the application to which the fee relates (the relevant application); and
(d) any information or material required under subregulation (3) has been given to the Secretary.
(2) An application under subregulation (1) must:
(a) state the reasons why paying the full amount of the fee before the consideration or audit of the relevant application commences would cause financial hardship to the applicant; and
(b) have with it documents or other material in support of the application.
(3) The Secretary may reasonably require information or material in addition to the documents or material mentioned in paragraph (2)(b).
(4) If the Secretary approves an application for payment by instalments:
(a) half of the fee is due for payment before the commencement of the consideration or audit of the relevant application; and
(b) one‑quarter of the fee is due for payment at the end of one month after the last day when the amount referred to in paragraph (a) may be paid; and
(c) the remaining one‑quarter of the fee is due for payment:
(i) if the relevant application is withdrawn—when the application is withdrawn; and
(ii) in any other case—when the applicant is notified of the Secretary’s decision in respect of the relevant application under section 41EE or 41FJ of the Act.
(5) If the Secretary receives an application for payment by instalments, the Secretary must:
(a) within 30 days of receiving the application and any information or material required under subregulation (3), give notice, in writing, to the applicant stating whether the application has been approved; and
(b) if the application is approved, include with the notice information about the amount of each instalment and when it is due for payment.
(6) If:
(a) the Secretary approves an application for payment by instalments; and
(b) any amount of the instalment payable by the applicant is not paid when it becomes due for payment;
the balance of the fee becomes due for payment.
(7) This regulation does not apply if another assessment fee, or an evaluation fee under section 24 of the Act, (or part of either of those kinds of fee) that is due for payment by the applicant is unpaid.
9.6 Reduction of assessment fees
The Secretary may reduce by 70% the amount of an assessment fee specified in Schedule 5 in relation to a medical device if the supply of the medical device:
(a) is in the interest of public health; and
(b) would not be commercially viable for the manufacturer or sponsor of the medical device if the full amount of the fee were paid.
9.7 Reduction of assessment fees—abridged assessment
(1) This regulation applies to an assessment fee specified in Part 1 of Schedule 5 in relation to any of the following:
(a) items 1.2, 1.3 and 1.3A (review of conformity assessment certificate);
(b) items 1.9 and 1.9A (initial assessment under conformity assessment procedures);
(c) item 1.10 (assessment consequent on a change to:
(i) a medical device; or
(ii) the quality management system applying to a medical device);
(ca) item 1.10A (assessment because of changes or proposed changes to:
(i) an IVD medical device; or
(ii) the quality management system applying to an IVD medical device);
(d) items 1.13, 1.14, 1.14A, 1.14B and 1.14C (application subject to audit assessment);
(e) item 1.16 (intermediate stage assessment or verification procedures).
(2) The Secretary may reduce the amount of the assessment fee if the Secretary has information that allows the assessment to be abridged, being information about:
(a) the medical device to which the fee relates; or
(b) some or all aspects of whether the conformity assessment procedures have been applied to the medical device.
Part 10—Miscellaneous
10.1 Authorised persons
The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:
(a) an officer of the Department, of another Department or of an authority of the Commonwealth;
(b) an officer of:
(i) a Department of State of a State; or
(ii) a Department or administrative unit of the Public Service of a Territory; or
(iii) an authority of a State or of a Territory;
being a Department, unit or authority that has functions relating to health matters.
10.2 Information about sponsor
(1) The sponsor of a medical device must ensure that the sponsor’s name and address are:
(a) provided with the device in such a way that a user of the device can readily identify the sponsor; and
(b) located in accordance with clause 13.2 in Schedule 1.
Penalty: 10 penalty units.
(2) If the sponsor of a medical device arranges for a label to be attached or affixed to the device for the purpose of complying with subregulation (1) or for any other purpose (for example, to comply with a labelling requirement under the law of a State or Territory), the label must not in any way adulterate the device or obscure the information provided with the device by the manufacturer.
Penalty: 10 penalty units.
10.3 Custom‑made medical devices—information about manufacturer
(1) The manufacturer of a custom‑made medical device that is manufactured in Australia must, within 2 months after the medical device is first manufactured in Australia, give the following information about the device to the Secretary:
(a) the manufacturer’s name and business address;
(b) a description of the kinds of medical devices being custom‑made by the manufacturer (including the device nomenclature system code for any such devices).
Penalty: 10 penalty units.
(2) The sponsor of a custom‑made medical device that is imported into Australia must, within 2 months after the medical device is first imported into Australia, give the following information about the device to the Secretary:
(a) the sponsor’s name and address;
(b) the manufacturer’s name and business address;
(c) a description of the kinds of medical devices being custom‑made by the manufacturer (including the device nomenclature system code for any such devices).
Penalty: 10 penalty units.
10.4 Offences—period for notifying adverse events (Act s 41MP)
For paragraph 41MP(1)(c) of the Act, the period for giving information of a kind mentioned in subsection 41MP(2) of the Act is the relevant period specified in regulation 5.7.
10.4A Secretary may maintain a system to enhance safe and effective use of particular medical devices
(1) The Secretary may, for the purpose of performing his or her functions, or exercising his or her powers, in relation to therapeutic goods (including under the Act or under another law), maintain either or both of the following:
(a) a system that is designed to enhance the safe and effective use of implantable breast medical devices (an implantable breast medical devices registry);
(b) a system that is designed to enhance the safe and effective use of implantable cardiac medical devices (an implantable cardiac medical devices registry).
(2) An implantable breast medical devices registry, or an implantable cardiac medical devices registry, may involve any of the following:
(a) collecting and analysing data and information in relation to the relevant medical devices;
(b) monitoring the safety and performance of the relevant medical devices;
(c) identifying particular medical devices (if any) in relation to which there are safety or performance risks or concerns;
(d) providing information about the safety and performance of the relevant medical devices to:
(i) authorities or bodies of the Commonwealth, a State or a Territory that have functions relating to therapeutic goods or health; or
(ii) health professionals; or
(iii) persons or bodies involved in the manufacture, importation or supply of the relevant medical devices in Australia; or
(iv) patients; or
(v) the general public.
(3) For paragraph (2)(a), the following are examples of data and information that may be collected and analysed in relation to the relevant medical devices:
(a) data and information relating to the safety and performance of the relevant medical devices;
(b) data and information about any revision procedures relating to the relevant medical devices and the reasons for those procedures;
(c) in relation to each particular medical device that has been implanted in a patient:
(i) information identifying the medical device, including the brand and batch or serial number; and
(ii) the date on which the medical device was implanted; and
(iii) the name of the hospital or surgery where the medical device was implanted; and
(iv) data or information that tracks the performance of the medical device and the patient outcomes following implant of the medical device.
(4) The Secretary may enter into a written agreement with a person or body for the purpose of maintaining an implantable breast medical devices registry or an implantable cardiac medical devices registry.
(5) An implantable breast medical devices registry or an implantable cardiac medical devices registry:
(a) may be maintained at a place and in a form that is acceptable to the Secretary; and
(b) may involve keeping records, or carrying out other actions, by electronic means.
10.5 Delegation—powers and functions under these Regulations
The Secretary may, by signed instrument, delegate a power or function of the Secretary under these Regulations to an officer of the Department.
10.6 Delegation—powers under paragraph 41HB(1)(d) of the Act
(1) In this regulation:
delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary, under paragraph 41HB(1)(d) of the Act, to approve the use of a specified medical device or kind of medical device in the treatment of a person.
(2) A delegate may only be a person who:
(a) is a medical practitioner registered in a State or internal Territory and employed by an institution that has an ethics committee; and
(b) is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.
(3) If:
(a) a person proposes another person under paragraph (2)(b) as a person to be a delegate; and
(b) that other person becomes a delegate;
the first‑mentioned person must supervise each approval that the delegate grants under the delegation.
(4) An instrument of delegation must describe the person or class of persons to be treated with the medical device or kind of medical device to which the delegation relates.
(5) A delegation may be made for the purpose of allowing the delegate to grant an approval in relation to:
(a) a particular medical device or kind of medical device; or
(b) a particular class of medical devices;
for treating a specific illness or condition.
(6) A delegate may grant an approval under a delegation only if:
(a) a medical practitioner, other than the delegate, has stated in writing that the person who is to be treated with the medical device of a kind to which the approval relates has an illness or condition that requires treatment with that kind of medical device; and
(b) an ethics committee has agreed to the granting of an approval under paragraph 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the kind of medical device to which the delegation relates.
10.6A Delegation of Secretary’s powers under section 41HD of the Act
The following positions are prescribed for the purposes of subsection 57(9) of the Act:
(a) First Assistant Secretary, Medicines Regulation Division;
(b) First Assistant Secretary, Medical Devices and Product Quality Division;
(c) Chief Medical Adviser, Health Products Regulation Group;
(d) each position classified as Medical Officer Class 5, Health Products Regulation Group.
10.6B Forms or manners—software requirements
If a provision of these Regulations provides for the approval or specification of a form or manner of giving an application, notice or other document, the approval or specification may require or permit the application, notice or other document 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.
10.7 Review of decisions
(1) In this regulation:
decision has the same meaning as in the Administrative Appeals Tribunal Act 1975.
initial decision means a decision of the Secretary under any of the following provisions:
(a) subparagraph 4.3C(1)(b)(ii);
(aa) subregulation 4.3E(1);
(ab) subregulation 4.10(2);
(aba) the following provisions (about conformity assessment body determinations):
(i) subregulation 4A.6(1);
(ii) subparagraph 4A.7(3)(a)(i) or (ii);
(iii) subregulation 4A.7(5);
(iv) regulation 4A.20;
(v) subregulation 4A.22(3);
(vi) subregulation 4A.23(1);
(vii) subregulation 4A.26(1);
(viii) subregulation 4A.27(1);
(ix) subregulation 4A.28(1);
(x) subregulation 4A.29(1);
(ac) subparagraph 5.4B(1)(b)(ii);
(ad) subregulation 5.4D(1);
(ae) the following provisions (about conformity assessment body determination assessment fees):
(i) regulation 9.1C;
(ii) subregulation 9.1D(1);
(iii) subregulation 9.1F(2);
(b) paragraph 9.4(2)(a);
(c) subregulation 9.5(1).
reviewable decision means a decision of the Minister under subregulation (4).
(2) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.
(3) A person whose interests are affected by an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.
(3A) Despite subregulation (3), only the following persons may make a request under that subregulation in relation to a conformity assessment (priority applicant) determination:
(a) if the initial decision was to refuse to make the determination—the person who applied for the determination;
(b) if the initial decision was to revoke the determination—the priority applicant specified in the determination.
(3B) Despite subregulation (3), only the following persons may make a request under that subregulation in relation to a medical devices (priority applicant) determination:
(a) if the initial decision was to refuse to make the determination—the person who applied for the determination;
(b) if the initial decision was to revoke the determination—the priority applicant specified in the determination.
(4) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (3), and may:
(a) confirm the initial decision; or
(b) revoke the initial decision; or
(c) revoke the initial decision and make a decision in substitution for the initial decision.
(5) After reconsidering an initial decision, the Minister must give to the applicant a notice in writing stating:
(a) the result of the reconsideration; and
(b) that the applicant may, unless subsection 28(4) of the Administrative Appeals Tribunal Act 1975 applies:
(i) apply for a statement setting out the reasons for the decision on reconsideration; and
(ii) subject to that Act, make an application to the Administrative Appeals Tribunal for review of that decision.
(6) If a person who makes a request under subregulation (3) does not receive notice of the decision of the Minister on reconsideration within 60 days after making the request, the Minister is taken to have confirmed the initial decision.
(7) If written notice of the making of an initial decision is given to a person whose interests are affected by the decision, the notice must include a statement to the effect that a person whose interests are affected by the decision may:
(a) seek a reconsideration of the decision under this regulation; and
(b) subject to the Administrative Appeals Tribunal Act 1975, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Appeals Tribunal for review of that decision.
(8) Any failure to comply with the requirements of subregulation (6) or (7) in relation to a decision does not affect the validity of the decision.
(9) Application may be made to the Administrative Appeals Tribunal for review of a reviewable decision.
Note: Under section 27A of the Administrative Appeals Tribunal Act 1975, the decision‑maker must give to any person whose interests are affected by the decision notice, in writing or otherwise, of the making of the decision and of the person’s right to have the decision reviewed. In giving that notice, the decision‑maker must have regard to the Code of Practice determined under section 27B of that Act (Gazette No. S 342, 7 December 1994), accessible on the Internet at: http://scaleplus.law.gov.au/html/instruments/0/14/0/IN000020.htm
Part 11—Transitional provisions
Division 11.1—Transitional provisions relating to the Therapeutic Goods (Medical Devices) Amendment Regulations 2010 (No. 1)
Subdivision A—Preliminary
11.1 Interpretation
(1) In this Division:
2010 Amendment Regulations means the Therapeutic Goods (Medical Devices) Amendment Regulations 2010 (No. 1) as in force immediately before 1 July 2014.
approved transitional device means an IVD medical device (other than an in‑house IVD medical device) that, immediately before 1 July 2010:
(a) was a diagnostic good for in vitro use; and
(b) was declared not to be a medical device under subsection 41BD(3) of the Act; and
(c) was:
(i) exempt from listing or registration under Part 3‑2 of the Act because item 3 of Schedule 5A to the Therapeutic Goods Regulations 1990 applied to the device; or
(ii) covered by an approval under paragraph 19(1)(b) of the Act; or
(iii) a device for which an application for approval under paragraph 19(1)(b) of the Act had been made but not finally determined.
diagnostic good for in vitro use has the same meaning as in the Therapeutic Goods Regulations 1990 as in force on 30 June 2010.
exempt transitional device means an IVD medical device (other than an in‑house IVD medical device) that, immediately before 1 July 2010:
(a) was a diagnostic good for in vitro use; and
(b) was declared not to be a medical device under subsection 41BD(3) of the Act; and
(c) was exempt from listing or registration under Part 3‑2 of the Act; and
(d) was not a device to which item 3 of Schedule 5A to the Therapeutic Goods Regulations 1990 applied.
listed or registered transitional device means an IVD medical device (other than an in‑house IVD medical device) that, immediately before 1 July 2010:
(a) was a diagnostic good for in vitro use; and
(b) was declared not to be a medical device under subsection 41BD(3) of the Act; and
(c) was:
(i) listed or registered under Part 3‑2 of the Act; or
(ii) a device for which an effective application for listing or registration under Part 3‑2 of the Act had been made but not finally determined.
transitional device means:
(a) a Class 1 in‑house IVD medical device that is in existence before 1 July 2017; or
(b) a Class 2 in‑house IVD medical device that is in existence before 1 July 2017; or
(c) a Class 3 in‑house IVD medical device that is in existence before 1 July 2017; or
(d) a Class 4 in‑house IVD medical device that is in existence before 1 July 2016; or
(e) a listed or registered transitional device; or
(f) an approved transitional device; or
(g) an exempt transitional device.
transitional period means:
(a) for a transitional device that is not an in‑house IVD medical device—the period starting on 1 July 2014 and ending immediately before the transition day for the device; and
(b) for a transitional device that is an in‑house IVD medical device—the period starting on the later of:
(i) 1 July 2014; and
(ii) the day the device comes into existence;
and ending immediately before the transition day for the device.
transition day, for a transitional device, means the day on which Schedule 1 to the 2010 Amendment Regulations starts to apply, for all purposes, in relation to the device.
Meaning of finally determined
(2) For this Division, an application is finally determined at the first time both the following conditions are met:
(a) a decision has been made not to grant the application;
(b) there is no longer any possibility of a change in the outcome of the decision.
(3) For paragraph (2)(b), the possibility of a discretion being exercised after the period has ended, to extend the period for seeking review by a court or tribunal of the decision or for starting other proceedings (including appeals) arising out of the application, decision or review, is not to be considered.
References to including a device in the Register
(4) In this Division, a reference to including a device in the Register is a reference to including the device in the Register under Chapter 4 of the Act.
11.2 Application of 2010 Amendment Regulations
(1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device as set out in Subdivisions C to F of this Division unless:
(a) the device was included in the Register before 1 July 2014; or
(b) an effective application for including the device in the Register was made before 1 July 2014 and the application was finally determined before that date.
(2) To avoid doubt, the amendments made by Schedule 1 to the 2010 Amendment Regulations apply, for all purposes, on and after 1 July 2014 in relation to:
(a) a transitional device covered by paragraph (1)(a); and
(b) a transitional device covered by paragraph (1)(b); and
(c) an IVD medical device that is not a transitional device.
Subdivision B—General provisions relating to transitional devices
11.3 Application of this Subdivision
This Subdivision applies in relation to a transitional device unless:
(a) the device was included in the Register before 1 July 2014; or
(b) an effective application for including the device in the Register was made before 1 July 2014 and the application was finally determined before that date.
11.4 Transitional devices exempted from requirement to be included in the Register
(1) For paragraph 41HA(1)(b) of the Act, a transitional device is exempt from the operation of Division 3 of Part 4‑11 of the Act during the transitional period for the device.
(2) Subregulation 7.1(3) does not apply in relation to a transitional device during the transitional period for the device.
(3) Regulation 3.10 does not apply in relation to a transitional device, during the transitional period for the device, for a purpose connected with:
(a) an application for a conformity assessment certificate in respect of the device; or
(b) issuing a conformity assessment certificate in respect of the device; or
(c) an application for including the device in the Register; or
(d) including the device in the Register.
11.5 Essential principles for transitional devices
(1) For section 41CA of the Act, the essential principles set out in clauses 3 and 6 of Schedule 1 to these Regulations, as in force immediately before 1 July 2010, are prescribed for a transitional device during the transitional period for the device, for a purpose other than a purpose mentioned in subregulation (2).
(2) Regulation 2.1 and Schedule 1 to these Regulations as in force on and after 1 July 2010 apply in relation to a transitional device for a purpose connected with:
(a) an application for a conformity assessment certificate in respect of the device; or
(b) issuing a conformity assessment certificate in respect of the device; or
(c) an application for including the device in the Register; or
(d) including the device in the Register;
and not for any other purpose, during the transitional period for the device.
Subdivision C—Listed or registered transitional devices and exempt transitional devices
11.6 Application of this Subdivision
This Subdivision applies in relation to the following devices:
(a) a listed or registered transitional device;
(b) an exempt transitional device.
11.7 Application of 2010 Amendment Regulations—certain purposes
The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device, on and after 1 July 2014, for purposes connected with:
(a) an application for a conformity assessment certificate in respect of the device; or
(b) issuing a conformity assessment certificate in respect of the device; or
(c) an application for including the device in the Register; or
(d) including the device in the Register.
11.8 Application of 2010 Amendment Regulations—conformity assessment certificate required and applied for before 1 September 2014
(1) This regulation applies in relation to the device if:
(a) a conformity assessment certificate is required under section 41EA of the Act before an effective application for including the device in the Register may be made; and
(b) an effective application for a conformity assessment certificate in respect of the device is made before 1 September 2014.
Certificate issued and inclusion application made before 1 July 2015—device included in Register
(2) If:
(a) a conformity assessment certificate in respect of the device is issued before 1 June 2015; and
(b) an effective application for including the device in the Register is made before 1 July 2015; and
(c) the device is included in the Register;
the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device, for all purposes, on and after the day the device is included in the Register.
Certificate issued and inclusion application made before 1 July 2015—device not included in Register
(3) If:
(a) a conformity assessment certificate in respect of the device is issued before 1 June 2015; and
(b) an effective application for including the device in the Register is made before 1 July 2015; and
(c) the application for including the device in the Register is finally determined;
the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device, for all purposes, on and after the day the application for including the device in the Register is finally determined.
Certificate issued but inclusion application not made before 1 July 2015
(4) If:
(a) a conformity assessment certificate in respect of the device is issued before 1 June 2015; and
(b) an effective application for including the device in the Register is not made before 1 July 2015;
the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device, for all purposes, on and after 1 July 2015.
Certificate issued on or after 1 June 2015 and inclusion application made within 30 days—device included in Register
(5) If:
(a) a conformity assessment certificate in respect of the device is issued on or after 1 June 2015; and
(b) an effective application for including the device in the Register is made no later than 30 days after the day the certificate is issued; and
(c) the device is included in the Register;
the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device, for all purposes, on and after the day the device is included in the Register.
Certificate issued on or after 1 June 2015 and inclusion application made within 30 days—device not included in Register
(6) If:
(a) a conformity assessment certificate in respect of the device is issued on or after 1 June 2015; and
(b) an effective application for including the device in the Register is made no later than 30 days after the day the certificate is issued; and
(c) the application for including the device in the Register is finally determined;
the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device, for all purposes, on the day the application for including the device in the Register is finally determined.
Certificate issued on or after 1 June 2015 but inclusion application not made within 30 days
(7) If:
(a) a conformity assessment certificate in respect of the device is issued on or after 1 June 2015; and
(b) an effective application for including the device in the Register is not made within 30 days after the day the certificate is issued;
the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device, for all purposes, 30 days after the day the certificate is issued.
Certificate application finally determined and certificate not issued
(8) If the application for the conformity assessment certificate is finally determined, the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device, for all purposes, on and after the day the application for the certificate is finally determined.
11.9 Application of 2010 Amendment Regulations—conformity assessment certificate required but not applied for before 1 September 2014
If:
(a) a conformity assessment certificate is required under section 41EA of the Act before an effective application for including the device in the Register may be made; and
(b) an effective application for a conformity assessment certificate in respect of the device is not made before 1 September 2014;
the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device, for all purposes, on and after 1 September 2014.
11.10 Application of 2010 Amendment Regulations—conformity assessment certificate not required
(1) This regulation applies in relation to the device if a conformity assessment certificate is not required under section 41EA of the Act before an effective application for including the device in the Register may be made.
Inclusion application made before 1 July 2015—device included in Register
(2) If:
(a) an effective application for including the device in the Register is made before 1 July 2015; and
(b) the device is included in the Register;
the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device, for all purposes, on and after the day the device is included in the Register.
Inclusion application made before 1 July 2015—device not included in Register
(3) If:
(a) an effective application for including the device in the Register is made before 1 July 2015; and
(b) the application for including the device in the Register is finally determined;
the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device, for all purposes, on and after the day the application for including the device in the Register is finally determined.
Inclusion application not made before 1 July 2015
(4) If an effective application for including the device in the Register is not made before 1 July 2015, the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device, for all purposes, on and after 1 July 2015.
11.11 Cancellation of listing or registration
If a listed or registered transitional device is listed or registered under Part 3‑2 of the Act immediately before 1 July 2014, the listing or registration is taken to be cancelled on the transition day for the device.
Subdivision D—Approved transitional devices
11.12 Application of this Subdivision
This Subdivision applies in relation to an approved transitional device.
11.13 Application of 2010 Amendment Regulations—certain purposes
The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to an approved transitional device, on and after 1 July 2014, for purposes connected with:
(a) an application for a conformity assessment certificate in respect of the device; or
(b) issuing a conformity assessment certificate in respect of the device; or
(c) an application for including the device in the Register; or
(d) including the device in the Register.
11.14 Application of 2010 Amendment Regulations—all purposes
The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to an approved transitional device, for all purposes, on and after:
(a) if the device is covered by subparagraph (c)(i) of the definition of approved transitional device in subregulation 11.1(1)—the day the device ceases to be a device to which item 3 of Schedule 5A to the Therapeutic Goods Regulations 1990 applies; and
(b) if the device is covered by subparagraph (c)(ii) of the definition of approved transitional device in subregulation 11.1(1)—the day the approval for the device ceases to have effect; and
(c) if the device is covered by subparagraph (c)(iii) of the definition of approved transitional device in subregulation 11.1(1):
(i) if approval is given for the device under paragraph 19(1)(b) of the Act—the day the approval ceases to have effect; and
(ii) in any other case—the day the application for approval is finally determined.
Subdivision E—Class 4 in‑house IVD medical devices
11.15 Application of this Subdivision
This Subdivision applies in relation to a transitional device that is a Class 4 in‑house IVD medical device.
11.16 Application of 2010 Amendment Regulations—certain purposes
The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after the later of the following days:
(a) 1 July 2014;
(b) the day on which the device comes into existence;
for purposes connected with:
(c) an application for a conformity assessment certificate in respect of the device; or
(d) issuing a conformity assessment certificate in respect of the device; or
(e) an application for including the device in the Register; or
(f) including the device in the Register.
11.17 Application of 2010 Amendment Regulations—conformity assessment certificate applied for before 1 July 2016
(1) This regulation applies in relation to the device if an application for a conformity assessment certificate in respect of the device is made before 1 July 2016.
Certificate issued and inclusion application made before 1 July 2017—device included in Register
(2) If:
(a) a conformity assessment certificate in respect of the device is issued before 1 June 2017; and
(b) an effective application for including the device in the Register is made before 1 July 2017; and
(c) the device is included in the Register;
the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device, for all purposes, on and after the day the device is included in the Register.
Certificate issued and inclusion application made before 1 July 2017—device not included in Register
(3) If:
(a) a conformity assessment certificate in respect of the device is issued before 1 June 2017; and
(b) an effective application for including the device in the Register is made before 1 July 2017; and
(c) the application for including the device in the Register is finally determined;
the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device, for all purposes, on and after the day the application for including the device in the Register is finally determined.
Certificate issued but inclusion application not made before 1 July 2017
(4) If:
(a) a conformity assessment certificate in respect of the device is issued before 1 June 2017; and
(b) an effective application for including the device in the Register is not made before 1 July 2017;
the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device, for all purposes, on and after 1 July 2017.
Certificate issued on or after 1 June 2017 and inclusion application made within 30 days—device included in Register
(5) If:
(a) a conformity assessment certificate in respect of the device is issued on or after 1 June 2017; and
(b) an effective application for including the device in the Register is made no later than 30 days after the day the certificate is issued; and
(c) the device is included in the Register;
the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device, for all purposes, on and after the day the device is included in the Register.
Certificate issued on or after 1 June 2017 and inclusion application made within 30 days—device not included in Register
(6) If:
(a) a conformity assessment certificate in respect of the device is issued on or after 1 June 2017; and
(b) an effective application for including the device in the Register is made no later than 30 days after the day the certificate is issued; and
(c) the application for including the device in the Register is finally determined;
the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device, for all purposes, on the day the application for including the device in the Register is finally determined.
Certificate issued on or after 1 June 2017 and inclusion application not made within 30 days
(7) If:
(a) a conformity assessment certificate in respect of the device is issued on or after 1 June 2017; and
(b) an effective application for including the device in the Register is not made within 30 days after the day the certificate is issued;
the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device, for all purposes, 30 days after the day the certificate is issued.
(8) If the amendments made by Schedule 1 to the 2010 Amendment Regulations do not apply in relation to the device, for all purposes, under any of subregulations (2) to (7) of this regulation, then the amendments apply in relation to the device under regulation 11.18.
11.18 Application of 2010 Amendment Regulations—devices not covered by regulation 11.17
(1) This regulation applies in relation to the device if the amendments made by Schedule 1 to the 2010 Amendment Regulations do not apply in relation to the device, for all purposes, under any of subregulations 11.17(2) to (7).
Note 1: This regulation will apply, for example, in relation to a device if an application for a conformity assessment certificate is not made in respect of the device before 1 July 2016.
Note 2: The amendments made by Schedule 1 to the 2010 Amendment Regulations are affected by amendments made by Part 1 of Schedule 1 to the Therapeutic Goods (Medical Devices) Amendment (In Vitro Diagnostic Medical Devices) Regulation 2015. Regulation 11.25 deals with the application of those 2015 amendments.
Inclusion application made before 1 July 2017—device included in Register
(2) If:
(a) an effective application for including the device in the Register is made before 1 July 2017; and
(b) the device is included in the Register;
the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device, for all purposes, on and after the day the device is included in the Register.
Inclusion application made before 1 July 2017—application withdrawn or finally determined
(3) If:
(a) an effective application for including the device in the Register is made before 1 July 2017; and
(b) the application is withdrawn or is finally determined;
the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device, for all purposes, on and after the day the application is withdrawn or is finally determined (as the case may be).
Inclusion application not made before 1 July 2017
(4) If an effective application for including the device in the Register is not made before 1 July 2017, the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device, for all purposes, on and after 1 July 2017.
Subdivision F—Class 1, 2 and 3 in‑house IVD medical devices
11.20 Application of this Subdivision
This Subdivision applies in relation to a transitional device that is any of the following:
(a) a Class 1 in‑house IVD medical device;
(b) a Class 2 in‑house IVD medical device;
(c) a Class 3 in‑house IVD medical device.
11.21 Application of 2010 Amendment Regulations for all purposes
The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device, for all purposes, on and after 1 July 2017.
Note: The amendments made by Schedule 1 to the 2010 Amendment Regulations are affected by amendments made by Part 2 of Schedule 1 to the Therapeutic Goods (Medical Devices) Amendment (In Vitro Diagnostic Medical Devices) Regulation 2015. Regulation 11.26 deals with the application of those 2015 amendments.
Division 11.2—Transitional provisions relating to joint replacements
11.22A Purpose of this Division
This Division includes transitional provisions relating to:
(a) the Therapeutic Goods (Medical Devices) Amendment Regulation 2012 (No. 1); and
(b) the Therapeutic Goods (Medical Devices) Amendment (Joint Replacements) Regulation 2015.
11.22 Certain Class IIb medical devices
(1) This regulation applies to a joint replacement medical device.
Note: Joint replacement medical device is defined in the Dictionary.
(2) If an application is made before 1 July 2012 to include a medical device mentioned in subregulation (1) in the Register, but is not finally determined on 1 July 2012, the medical device must be included in the Register as a Class IIb medical device if the application is successful.
(3) If:
(a) a medical device mentioned in subregulation (1) is included in the Register as a Class IIb medical device on or after 1 July 2012; and
(b) an application is made to include the medical device in the Register as a Class III medical device;
no annual charge is payable for inclusion of the medical device in the Register as a Class III medical device until after 30 June 2015.
(4) Subregulation 5.3(1) does not apply to an application mentioned in subregulation (3).
(5) No application fee is payable for an application mentioned in subregulation (3) if the application is made before 1 July 2013.
(6) If a medical device mentioned in subregulation (1) is included in the Register as a Class IIb medical device on 1 July 2015, the inclusion of the medical device in the Register is cancelled on that day, unless:
(a) an application was made before 1 July 2015 for the medical device to be included in the Register as a Class III medical device; and
(b) the Secretary has not decided whether or not to include the medical device in the Register.
(7) If the application mentioned in paragraph (6)(a) is unsuccessful, the inclusion of the Class IIb medical device in the Register is cancelled on the later of 1 July 2015 and the day that notification is given to the applicant that the application was not successful.
(8) In this regulation, an application is finally determined at the first time that both the following conditions are met:
(a) a decision has been made whether or not to grant the application;
(b) there is no longer any possibility of a change in the outcome of the decision.
(9) For paragraph 8(b), the exercise of a discretion, after the period has ended, to extend a period for seeking review by a court or tribunal of the decision or for starting other proceedings (including appeals) arising out of the application, decision or review is not to be considered.
11.23 Refund of fees in relation to inclusion of certain devices in the Register as Class III medical devices
(1) This regulation applies in relation to an implantable medical device if:
(a) the device is of the kind referred to in subregulation 11.22(1) of the old Regulations; and
(b) the device is not a joint replacement medical device; and
(c) an application to include the device in the Register as a Class III medical device was made on or after 1 July 2012 and before the commencement of the amending Regulation.
Note: Subregulation 11.22(1) of the old Regulations referred to an implantable medical device that is intended by the manufacturer to be any of the following:
(a) a total or partial shoulder joint replacement;
(b) a total or partial hip joint replacement;
(c) a total or partial knee joint replacement.
(2) The Secretary may refund any fee paid in relation to the application.
(3) If any annual charge has been paid in respect of the inclusion of the device in the Register as a Class III medical device, the Secretary may refund the difference between the annual charge paid and the annual charge that would have been payable in respect of the inclusion of the device in the Register as a Class IIb medical device.
(4) In this regulation:
amending Regulation means the Therapeutic Goods (Medical Devices) Amendment (Joint Replacements) Regulation 2015.
old Regulations means these Regulations as in force immediately before the commencement of the amending Regulation.
Division 11.3—Transitional provisions relating to the Therapeutic Goods (Medical Devices) Amendment (In Vitro Diagnostic Medical Devices) Regulation 2015
11.24 Definitions
In this Division:
2010 Amendment Regulations has the meaning given by regulation 11.1.
2015 Amendment Regulations means the Therapeutic Goods (Medical Devices) Amendment (In Vitro Diagnostic Medical Devices) Regulation 2015.
commencement day means the day this Division commences.
transitional device has the meaning given by regulation 11.1.
transition day has the meaning given by regulation 11.1.
11.25 Application of 2015 Amendment Regulations—transitional Class 4 in‑house IVD medical devices
(1) This regulation applies in relation to a transitional device that is a Class 4 in‑house IVD medical device.
(2) The amendments made by Part 1 of Schedule 1 to the 2015 Amendment Regulations apply in relation to the device, for a purpose connected with a matter mentioned in any of paragraphs 11.16(c) to (f), on and after the later of the following days:
(a) the commencement day;
(b) the day on which the device comes into existence.
(3) The amendments made by Part 1 of Schedule 1 to the 2015 Amendment Regulations apply in relation to the device, for all purposes, on and after the later of the following days:
(a) the commencement day;
(b) the transition day for the device.
11.26 Application of 2015 Amendment Regulations etc.—transitional Class 1, 2 and 3 in‑house IVD medical devices
(1) This regulation applies in relation to a transitional device that is a Class 1 in‑house IVD medical device, Class 2 in‑house IVD medical device or Class 3 in‑house IVD medical device.
(2) Subject to subregulations (3) and (4), the amendments made by Part 2 of Schedule 1 to the 2015 Amendment Regulations apply in relation to the device for all purposes, on and after 1 July 2017.
(3) If, before the commencement day, the manufacturer of the device has notified the Secretary of the matters referred to in subclause 1.2(1) of Part 6A of Schedule 3 (as inserted by Schedule 1 to the 2010 Amendment Regulations), the manufacturer is taken to have complied with the notification requirements in subclauses 6A.2(1) and (2) and paragraph (3)(a) of Part 6A of Schedule 3 in relation to the devices covered by the notification.
(4) If:
(a) on or after the commencement day and before 1 July 2017, the manufacturer of the device notifies the Secretary of the Class 1, 2 or 3 in‑house IVD medical devices being manufactured; and
(b) the notification is in accordance with subclauses 6A.2(2) and (3) of Part 6A of Schedule 3;
the manufacturer is taken to have complied with the notification requirements in subclauses 6A.2(1) and (2) and paragraph (3)(a) of Part 6A of Schedule 3 in relation to the devices covered by the notification.
Division 11.4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016
11.27 Application
(1) The amendments made by items 1, 12 and 13 of Schedule 3 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to medical devices included in the Register on or after the day that Schedule commences if the application for inclusion in the Register was made on or after that day.
Division 11.5—Transitional provisions relating to the Therapeutic Goods (Medical Devices) Amendment (Implantable Medical Devices) Regulations 2017
11.28 Definitions
In this Division:
amending regulations means the Therapeutic Goods (Medical Devices) Amendment (Implantable Medical Devices) Regulations 2017.
finally determined has the meaning given by subregulation 11.29(5).
inclusion day for an entry of a kind of medical device in the Register means the day on which the inclusion of that kind of device in the Register commences.
pre‑commencement entry: an entry of a kind of medical device in the Register is a pre‑commencement entry if that kind of medical device is included in the Register because of an application made before 1 December 2018 (whether the inclusion day for the entry occurred before, on or after 1 December 2018).
unique product identifier, in relation to a medical device, means the unique product identifier given to the device by its manufacturer to identify the device and any variants.
11.29 Surgical mesh—application of amendments
Applications and entries other than pre‑commencement entries
(1) The amendment made by Part 1 of Schedule 1 to the amending regulations applies on and after 1 December 2018 in relation to the following:
(a) an application for a kind of medical device to be included in the Register, if the application is made on or after 1 December 2018;
(b) an entry of a kind of medical device in the Register that is not a pre‑commencement entry.
Pre‑commencement entries
(2) Subject to subregulation (3), the amendment made by Part 1 of Schedule 1 to the amending regulations applies in relation to a pre‑commencement entry of a kind of medical device on and after:
(a) if medical devices of that kind are urogynaecological mesh—1 December 2020; or
(b) otherwise—1 December 2021.
(3) However, the amendment does not apply in relation to the pre‑commencement entry before the day mentioned in subregulation (4) if:
(a) the person applies under the Act:
(i) on or after the inclusion day for the pre‑commencement entry; and
(ii) on or after 1 December 2018; and
(iii) before the day mentioned in subregulation (2);
to have a kind (the new application kind) of medical device included in the Register; and
(b) the person gives to the Secretary a notice under regulation 11.30 in relation to the pre‑commencement entry; and
(c) the unique product identifier of the devices of the new application kind is the unique product identifier, or one of the unique product identifiers, stated in the notice.
(4) For the purposes of subregulation (3), the day is the day after the day on which:
(a) the person withdraws the application mentioned in paragraph (3)(a); or
(b) that application lapses under section 41FK of the Act; or
(c) that application is finally determined.
(5) The application is finally determined at the first time both the following conditions are met:
(a) a decision has been made whether or not to grant the application;
(b) there is no longer any possibility of a change in the outcome of the decision.
11.30 Surgical mesh—Secretary must be notified of unique product identifiers of devices supplied under pre‑commencement entries
(1) For the purposes of subsection 41FN(5A) of the Act, a person must give to the Secretary a notice in accordance with subregulation (2) if:
(a) a kind of medical device is included in the Register in relation to the person; and
(b) the entry of that kind of device is a pre‑commencement entry; and
(c) medical devices of that kind are surgical mesh.
(2) The notice must:
(a) be in writing; and
(b) state:
(i) the unique device number assigned to that kind of device under section 41FL of the Act; and
(ii) the unique product identifier given to each medical device (if any) of that kind that the person supplies in Australia; and
(c) be given to the Secretary before the later of:
(i) 1 May 2019; and
(ii) the day occurring 2 months after the inclusion day for the entry.
11.31 Patient information—application of amendments
Devices other than urogynaecological mesh
(1) The amendments made by Part 2 of Schedule 1 to the amending regulations apply on and after the day mentioned in column 1 of an item of the following table:
(a) to the extent that the amendments relate to a patient implant card or patient information leaflet mentioned in column 2 of the item; and
(b) in relation to:
(i) an application for a kind of medical device to be included in the Register; or
(ii) an entry of a kind of medical device in the Register;
mentioned in column 3 of the item;
if devices of that kind are not urogynaecological mesh.
| Entries and applications relating to medical devices other than urogynaecological mesh |
| Item | Column 1 Day amendments start applying | Column 2 Card or leaflet | Column 3 Application or entry |
| 1 | 1 December 2018 | patient information leaflet | (a) an application made on or after 1 December 2018; or (b) an entry that is not a pre‑commencement entry |
| 2 | 1 December 2020 | patient implant card | (a) an application made on or after 1 December 2020; or (b) an entry that is not a pre‑commencement entry |
| 3 | 1 December 2021 | (a) patient implant card; or (b) patient information leaflet | a pre‑commencement entry |
Urogynaecological mesh
(2) The amendments made by Part 2 of Schedule 1 to the amending regulations apply on and after the day mentioned in column 1 of an item of the following table in relation to:
(a) an application for a kind of medical device to be included in the Register; or
(b) an entry of a kind of medical device in the Register;
mentioned in column 2 of the item, if devices of that kind are urogynaecological mesh.
| Entries and application relating to urogynaecological mesh |
| Item | Column 1 Day amendments start applying | Column 2 Application or entry |
| 1 | 1 December 2018 | (a) an application made on or after 1 December 2018; or (b) an entry that is not a pre‑commencement entry |
| 2 | 1 December 2019 | a pre‑commencement entry |
Division 11.6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017
11.32 Definitions
In this Division:
Amendment Regulations means the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017.
commencement day means the day on which Part 3 of Schedule 4 to the Amendment Regulations commences.
11.33 Application—statements in relation to exempt devices
The amendments of regulations 7.2 and 8.2 of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to the use of a medical device in or on a person on or after the commencement day.
Division 11.7—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018
11.34 Application of amendments
The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a medical device imported into Australia:
(a) on or after the commencement of this regulation; or
(b) during the 12 months ending immediately before that commencement, if the device was held under the direct control of the sponsor immediately before that commencement.
Division 11.8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018
11.35 Application—regulation 4.3G (conditions applying automatically to conformity assessment certificates)
Regulation 4.3G applies to a conformity assessment certificate issued before, on or after 1 July 2018.
11.36 Application—regulation 5.13 (conditions applying automatically to medical devices included in the Register)
Regulation 5.13 applies to a kind of medical device included in the Register before, on or after 1 July 2018.
Division 11.9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018
11.37 Application of table item 1.5 in Part 1 of Schedule 5
(1) Table item 1.5 in Part 1 of Schedule 5, as amended by the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018, applies in relation to applications made on or after 1 July 2018.
(2) If, on or after 1 July 2018 and before the commencement of Part 1 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018, a person:
(a) applied for the inclusion in the Register of a Class I medical device intended by the manufacturer to be for export only; and
(b) paid the fee prescribed in relation to that application by table item 1.5 in Part 1 of Schedule 5 to these Regulations as in force before that commencement;
the Secretary must refund to the person the difference between the fee paid and the fee prescribed in relation to the application by that table item as in force after that commencement.
Schedule 1—Essential principles
(regulation 2.1)
Part 1—General principles
1 Use of medical devices not to compromise health and safety
A medical device is to be designed and produced in a way that ensures that:
(a) the device will not compromise the clinical condition or safety of a patient, or the safety and health of the user or any other person, when the device is used on a patient under the conditions and for the purposes for which the device was intended and, if applicable, by a user with appropriate technical knowledge, experience, education or training; and
(b) any risks associated with the use of the device are:
(i) acceptable risks when weighed against the intended benefit to the patient; and
(ii) compatible with a high level of protection of health and safety.
2 Design and construction of medical devices to conform with safety principles
(1) The solutions adopted by the manufacturer for the design and construction of a medical device must conform with safety principles, having regard to the generally acknowledged state of the art.
(2) Without limiting subclause (1), in selecting appropriate solutions for the design and construction of a medical device so as to minimise any risks associated with the use of the device, the manufacturer must:
(a) first, identify hazards and associated risks arising from the use of the device for its intended purpose, and foreseeable misuse of the device; and
(b) second, eliminate, or reduce, these risks as far as possible by adopting a policy of inherently safe design and construction; and
(c) third, if appropriate, ensure that adequate protection measures are taken, including alarms if necessary, in relation to any risks that cannot be eliminated; and
(d) fourth, inform users of any residual risks that may arise due to any shortcomings of the protection measures adopted.
(3) In paragraph (2)(d):
residual risk, for a medical device, means the risk remaining after the measures described in paragraphs (2)(a), (b) and (c) have been applied.
3 Medical devices to be suitable for intended purpose
A medical device must:
(a) perform in the way intended by the manufacturer; and
(b) be designed, produced and packaged in a way that ensures that it is suitable for one or more of the purposes mentioned in the definition of medical device in subsection 41BD(1) of the Act.
4 Long‑term safety
A medical device must be designed and produced in a way that ensures that if:
(a) the device is used within the period, indicated by the manufacturer, in which the device can be safely used; and
(b) the device is not subjected to stresses that are outside the stresses that can occur during normal conditions of use; and
(c) the device is regularly maintained and calibrated in accordance with the manufacturer’s instructions;
the characteristics and performances mentioned in clauses 1, 2 and 3 are not adversely affected.
5 Medical devices not to be adversely affected by transport or storage
A medical device must be designed, produced and packed in a way that ensures that the characteristics and performance of the device when it is being used for its intended purpose will not be adversely affected during transport and storage that is carried out taking account of the instructions and information provided by the manufacturer.
6 Benefits of medical devices to outweigh any undesirable effects
The benefits to be gained from the use of a medical device for the performance intended by the manufacturer must outweigh any undesirable effects arising from its use.
Part 2—Principles about design and construction
7 Chemical, physical and biological properties
7.1 Choice of materials
In ensuring that the requirements of Part 1 are met in relation to a medical device, particular attention must be given to:
(a) the chemical and physical properties of the materials used in the device; and
(b) the compatibility between the materials used and biological tissues, cells, body fluids and specimens;
having regard to the intended purpose of the device.
7.2 Minimisation of risks associated with contaminants and residues
(1) A medical device must be designed, produced and packed in a way that ensures that any risks associated with contaminants and residues that may affect a person who is involved in transporting, storing or using the device, or a patient, are minimised, having regard to the intended purpose of the device.
(2) In minimising risks, particular consideration must be given to the likely duration and frequency of any tissue exposure associated with the transportation, storage or use of the device.
7.3 Ability to be used safely with materials etc
(1) A medical device must be designed and produced in a way that ensures that the device can be used safely with any material, substance or gas with which the device may come into contact during normal use or use in routine procedures.
(2) If the device is intended to be used to administer medicine, it must be designed and produced in a way that ensures that the device:
(a) is compatible with the provisions and restrictions applying to the medicine to be administered; and
(b) allows the medicine to perform as intended.
7.4 Verification of incorporated substance
(1) If a medical device incorporates, or is intended to incorporate, as an integral part, a substance that, if used separately, might be considered to be a medicine that is intended to act on a patient in a way that is ancillary to the device:
(a) the safety and quality of the substance must be verified in accordance with the requirements for medicines; and
(b) the ancillary action of the substance must be verified having regard to the intended purpose of the device.
(2) For the purposes of this clause, any stable derivative of human blood or human plasma is considered to be a medicine.
7.5 Minimisation of risks associated with leaching substances
A medical device must be designed and produced in a way that ensures that any risks associated with substances that may leach from the device are minimised.
7.6 Minimisation of risks associated with ingress or egress of substances
A medical device must be designed and produced in a way that ensures that any risks associated with unintentional ingress of substances into, or unintentional egress of substances out of, the device are minimised, having regard to the nature of the environment in which the device is intended to be used.
8 Infection and microbial contamination
8.1 Minimisation of risk of infection and contamination
(1) A medical device must be designed and produced in a way that ensures that the risk of infection to a patient, a user, or any other person, is eliminated or minimised.
(2) The device must be designed in a way that:
(a) allows it to be easily handled; and
(b) if appropriate, minimises contamination of the device or specimen by the patient, user or other person; and
(c) if appropriate, minimises contamination of the patient, user or other person by the device or specimen.
8.2 Control of animal, microbial or recombinant tissues, tissue derivatives, cells and other substances
(1) This clause applies in relation to a medical device that contains:
(a) tissues, tissue derivatives, cells or substances of animal origin that have been rendered non‑viable; and
(b) tissues, tissue derivatives, cells or substances of microbial or recombinant origin.
(2) If the tissues, tissue derivatives, cells or substances originated from animals, the animals must have been subjected to appropriate veterinary controls and supervision, having regard to the intended use of the tissues, tissue derivatives, cells or substances.
(3) If the medical device contains tissues, tissue derivatives, cells or substances of animal origin, a record must be kept of the country of origin of each animal from which the tissues, tissue derivatives, cells or substances originated.
(4) The processing, preservation, testing and handling of tissues, tissue derivatives, cells or substances of animal, microbial or recombinant origin must be carried out in a way that ensures the highest standards of safety for a patient, the user of the device, and any other person.
(5) In particular, the production process must implement validated methods of elimination, or inactivation, in relation to viruses and other transmissible agents.
Note: This may not apply to certain IVD medical devices if the characteristics mentioned in subclause 8.2(5) are integral to the intended purpose of the IVD medical device.
8.3 Medical devices to be supplied in a sterile state
(1) This clause applies in relation to a medical device that is intended by the manufacturer to be supplied in a sterile state.
(2) The device must be designed, produced and packed in a way that ensures that the device is sterile when it is supplied, and will remain sterile, if stored and transported in accordance with the directions of the manufacturer, until the protective packaging is opened or damaged.
(3) The device must be produced and sterilised using an appropriate validated method.
(4) The device must be produced in appropriately controlled conditions.
8.4 Medical devices to be supplied in a non‑sterile state
(1) A medical device that is intended by the manufacturer to be supplied in a non‑sterile state must be packed in a way that ensures that the device maintains the level of cleanliness stipulated by the manufacturer.
(2) If the device is intended to be sterilised before it is used, the device must be packed in a way that:
(a) ensures that the risk of microbial contamination is minimised; and
(b) is suitable, having regard to the method of sterilisation that the manufacturer indicates is to be used for the device.
(3) The device must be produced in appropriately controlled conditions.
8.5 Distinction between medical devices supplied in sterile and non‑sterile state
If a medical device is supplied in both a sterile state and a non‑sterile state, the information provided with the device must clearly indicate whether the device is in a sterile state or a non‑sterile state.
9 Construction and environmental properties
9.1 Medical devices intended to be used in combination with other devices or equipment
A medical device that is intended by the manufacturer to be used in combination with another medical device or other equipment (including a connection system) must be designed and produced in a way that ensures that:
(a) the medical device, and any other device or equipment with which it is used, operate in a safe way; and
(b) the intended performance of the device, and any other device or equipment with which it is used, is not impaired.
9.2 Minimisation of risks associated with use of medical devices
A medical device must be designed and produced in a way that ensures that, as far as practicable, the following risks are removed or minimised:
(a) the risk of injury arising from the physical features of the device;
(b) any risks associated with reasonably foreseeable environmental conditions;
(c) the risk of reciprocal interference involving other devices that are normally used in an investigation or treatment of the kind for which the device is intended to be used;
(d) any risks arising if maintenance or calibration of the device is not possible;
(e) any risks associated with the ageing of materials used in the device;
(f) any risks associated with loss of accuracy of any measuring or control mechanism of the device;
(g) the risk of fire or explosion occurring during normal use of the device, and in the event of a single fault condition, especially if the device is intended to be exposed to flammable substances or substances that can cause combustion;
(h) the risks associated with disposal of any waste substances.
10 Medical devices with a measuring function
(1) A medical device that has a measuring function must be designed and produced in a way that ensures that the device provides accurate, precise and stable measurements within the limits indicated by the manufacturer and having regard to the intended purpose of the device.
(2) The measurement, monitoring and display scale of the device must be designed and produced in accordance with ergonomic principles, having regard to the intended purpose of the device.
(3) The measurements made by the device must be expressed:
(a) in Australian legal units of measurement or be compared to at least one point of reference indicated in Australian legal units of measurement; or
(b) if the device measures a physical quantity for which no Australian legal unit of measurement has been prescribed under the National Measurement Act 1960, in units approved in writing by the Secretary for the particular device.
11 Protection against radiation
11.1 Minimisation of exposure to radiation
A medical device must be designed and produced in a way that ensures that the exposure of a patient, the user, or any other person, to radiation is minimised, having regard to the levels of radiation required to enable the device to perform its therapeutic and diagnostic functions and the intended purpose of the device.
11.2 Medical devices intended to emit radiation
(1) This clause applies in relation to a medical device that is intended by the manufacturer to emit hazardous levels of visible or invisible radiation because the emission is necessary for a specific medical purpose, the benefit of which is considered to outweigh the risks inherent in the emission.
(2) The device must be designed and produced in a way that ensures that the user can control the level of the emission.
(3) The device must be designed and produced in a way that ensures the reproducibility and tolerance of relevant variable parameters.
(4) If practicable, the device must be fitted with a visual indicator or an audible warning, or both, that operates if potentially hazardous levels of radiation are emitted.
11.3 Minimisation of exposure to unintended radiation
A medical device must be designed and produced in a way that ensures that the exposure of a patient, the user, or any other person, to the emission of unintended, stray or scattered radiation is minimised.
11.4 Operating instructions
The operating instructions for a medical device that emits radiation must include detailed information about the following matters:
(a) the nature of the radiation emitted;
(b) the means by which patients and users can be protected from the radiation;
(c) ways to avoid misusing the device;
(d) ways to eliminate any risks inherent in the installation of the device.
11.5 Medical devices intended to emit ionising radiation—additional requirements
(1) This clause applies, in addition to clauses 11.1 to 11.4, in relation to a medical device that is intended by the manufacturer to emit ionising radiation.
(2) The device must be designed and produced in a way that ensures that, if practicable, the quantity, geometry and energy distribution (or quality) of radiation emitted can be controlled and varied, having regard to the intended purpose of the device.
(3) If the device is intended to be used for diagnostic radiology, the device must be designed and produced in a way that ensures that, when used in relation to a patient for a purpose intended by the manufacturer:
(a) the device achieves an appropriate image or output quality for that purpose; and
(b) the exposure of the patient, or the user, to radiation is minimised.
(4) If the device is intended to be used for therapeutic radiology, the device must be designed and produced in a way that ensures that the delivered dose of radiation, the type and energy of the radiation beam and, if appropriate, the energy distribution of the radiation beam, can be reliably controlled and monitored.
12 Medical devices connected to or equipped with an energy source
12.1 Medical devices incorporating electronic programmable systems
A medical device that incorporates an electronic programmable system must be designed and produced in a way that ensures that:
(a) the performance, reliability, and repeatability of the system are appropriate for the intended purpose of the device; and
(b) any consequent risks associated with a single fault condition in the system are minimised.
12.2 Safety dependent on internal power supply
(1) This clause applies in relation to a medical device if the safety of a patient on whom the device is to be used will depend on an internal power supply for the device.
(2) The device must be fitted with a means of determining the state of the power supply.
12.3 Safety dependent on external power supply
(1) This clause applies in relation to a medical device if the safety of a patient on whom the device is to be used will depend on an external power supply for the device.
(2) The device must be fitted with an alarm system that indicates whether a power failure has occurred.
12.4 Medical devices intended to monitor clinical parameters
A medical device that is intended by the manufacturer to be used to monitor one or more clinical parameters of a patient must be fitted with an appropriate alarm system to warn the user if a situation has developed that could lead to the death of the patient or a severe deterioration in the state of the patient’s health.
12.5 Minimisation of risk of electromagnetic fields
A medical device must be designed and produced in a way that ensures that the risk of an electromagnetic field being created that could impair the operation of other devices or equipment being used in the vicinity of the medical device is minimised.
12.6 Protection against electrical risks
A medical device must be designed and produced in a way that ensures that, as far as possible, when the device is installed correctly, and the device is being used for an intended purpose under normal conditions of use and in the event of a single fault condition, patients, users, and any other persons, are protected against the risk of accidental electric shock.
12.7 Protection against mechanical risks
A medical device must be designed and produced in a way that ensures that a patient, the user, and any other person, is protected against any mechanical risks associated with the use of the device.
12.8 Protection against risks associated with vibration
(1) A medical device must be designed and produced in a way that ensures that any risks associated with vibrations generated by the device are minimised.
(2) If vibrations are not part of the intended performance of the device, particular attention must be given to relevant technical progress, and the available means, for limiting vibrations, particularly at source.
12.9 Protection against risks associated with noise
(1) A medical device must be designed and produced in a way that ensures that any risks associated with noise emitted by the device are minimised.
(2) If noise is not part of the intended performance of the device, particular attention must be given to relevant technical progress, and the available means, for reducing the emission of noise, particularly at source.
12.10 Protection against risks associated with terminals and connectors
A medical device that is intended by the manufacturer to be connected to an electric, gas, hydraulic, pneumatic or other energy supply must be designed and produced in a way that ensures that any risks to the user associated with the handling of a terminal or connector on the device, in relation to the energy supply, are minimised.
12.11 Protection against risks associated with heat
A medical device must be designed and produced in a way that ensures that, during normal use, any accessible part of the device (other than any part intended by the manufacturer to supply heat or reach a given temperature), and any area surrounding an accessible part of the device, does not reach a potentially dangerous temperature.
12.12 Protection against risks associated with administration of energy or substances
(1) This clause applies in relation to a medical device that is intended by the manufacturer to be used to administer energy or a substance to a patient.
(2) The device must be designed and produced in a way that ensures that:
(a) the delivered rate and amount of energy, or of the substance, can be set and maintained accurately to ensure the safety of the patient and the user; and
(b) as far as possible, the accidental release of dangerous levels of energy or of the substance is prevented.
(3) The device must be fitted with a means of indicating or, if appropriate, preventing inadequacies in the rate and amount of energy, or of the substance, administered that might cause danger to the patient, the user or any other person.
(4) The functions of each control and indicator on the device must be clearly specified on the device.
(5) If the instructions for the operation of the device, or the operating or adjustment parameters for the device, are displayed by means of a visual system incorporated into the device, the instructions or parameters must be able to be understood by the user and, if appropriate, the patient.
12.13 Active implantable medical devices
(1) An active implantable medical device must incorporate, display, emit or exhibit a code or unique characteristic that can be used to identify:
(a) the type of device; and
(b) the manufacturer of the device; and
(c) the year of manufacture of the device.
(2) The code or unique characteristic must be able to be read without the need for surgery to the person in whom the device is implanted.
13 Information to be provided with medical devices
13.1 Information to be provided with medical devices—general
(1) The following information must be provided with a medical device:
(a) information identifying the device;
(b) information identifying the manufacturer of the device;
(c) information explaining how to use the device safely;
having regard to the training and knowledge of potential users of the device.
(2) In particular:
(a) the information required by clause 13.3 must be provided with a medical device; and
(b) if instructions for use of the device are required under subclause 13.4, the information mentioned in subclause 13.4(3) must be provided in those instructions.
(3) The information:
(a) must be provided in English; and
(b) may also be provided in any other language.
Note: The information may also include diagrams or drawings.
(4) The format, content and location of the information must be appropriate for the device and its intended purpose.
(5) Any number, letter, symbol, or letter or number in a symbol, used in the information must be legible and at least 1 millimetre high.
(6) If a symbol or identification colour that is not included in a medical device standard is used in the information provided with the device, or in the instructions for use of the device, the meaning of the symbol or identification colour must be explained in the information provided with the device or the instructions for use of the device.
13.2 Information to be provided with medical devices—location
(1) Unless it is impracticable or inappropriate to do so, the information required to be provided with a medical device must be provided on the device itself.
(2) If it is not practicable to comply with subclause (1) in relation to the provision of the information, the information must be provided:
(a) on the packaging used for the device; or
(b) in the case of devices that are packaged together because individual packaging of the devices for supply is not practicable—on the outer packaging used for the devices.
(3) If it is not practicable to comply with subclause (1) or (2) in relation to the provision of the information required under subregulation 10.2(1) or clause 13.3, the information must be provided on a leaflet supplied with the device.
(4) If it is not practicable to comply with subclause (1) or (2) in relation to the provision of the information required under clause 13.4, the information must be provided in a printed document or using other appropriate media.
13.3 Information to be provided with medical devices—particular requirements
The information mentioned in the following table must be provided with a medical device.
| Item | Information to be provided |
| 1 | The manufacturer’s name, or trading name, and address |
| 2 | The intended purpose of the device, the intended user of the device, and the kind of patient on whom the device is intended to be used (if this information is not obvious) |
| 3 | Sufficient information to enable a user to identify the device, or if relevant, the contents of packaging |
| 4 | Any particular handling or storage requirements applying to the device |
| 5 | Any warnings, restrictions, or precautions that should be taken, in relation to use of the device |
| 6 | Any special operating instructions for the use of the device |
| 7 | If applicable, an indication that the device is intended for a single use only |
| 8 | If applicable, an indication that the device has been custom‑made for a particular individual or health professional and is intended for use only by that individual or health professional |
| 9 | If applicable, an indication that: (a) if the device is a medical device other than an IVD medical device—the device is intended for pre‑market clinical investigation; or (b) if the device is an IVD medical device—the device is intended for performance evaluation only |
| 10 | For a sterile device, the word ‘STERILE’ and information about the method that was used to sterilise the device |
| 11 | The batch code, lot number or serial number of the device |
| 12 | If applicable, a statement of the date (expressed in a way that clearly identifies the month and year) up to when the device can be safely used |
| 13 | If the information provided with the device does not include the information mentioned in item 12—a statement of the date of manufacture of the device (this may be included in the batch code, lot number or serial number of the device, provided the date is clearly identifiable) |
| 14 | If applicable, the words ‘for export only’ |
Note: In addition to the information mentioned in the above table, regulation 10.2 requires certain information to be provided with a medical device.
13.4 Instructions for use
(1) Instructions for the use of a medical device must be provided with the device.
(2) However, instructions for the use of a medical device need not be provided with the device, or may be abbreviated, if:
(a) the device is a Class I medical device, a Class IIa medical device or a Class 1 IVD medical device; and
(b) the device can be used safely for its intended purpose without instructions.
(3) Instructions for the use of a medical device must include information mentioned in the following table that is applicable to the device.
| Item | Information to be provided |
| 1 | The manufacturer’s name, or trading name, and address |
| 2 | The intended purpose of the device, the intended user of the device, and the kind of patient on whom the device is intended to be used |
| 3 | Information about any risk arising because of other equipment likely to be present when the device is being used for its intended purpose (for example, electrical interference from electro‑surgical devices or magnetic field interference from magnetic resonance imaging devices) |
| 4 | Information about the intended performance of the device and any undesirable side effects caused by use of the device |
| 5 | Any contra‑indications, warnings, restrictions, or precautions that may apply in relation to use of the device |
| 6 | Sufficient information to enable a user to identify the device, or if relevant, the contents of packaging |
| 7 | Any particular handling or storage requirements applying to the device |
| 8 | If applicable, an indication that the device is intended for a single use only |
| 9 | If applicable, an indication that the device has been custom‑made for a particular individual or health professional and is intended for use only by that individual or health professional |
| 10 | If applicable, an indication that: (a) if the device is a medical device other than an IVD medical device—the device is intended for pre‑market clinical investigation; or (b) if the device is an IVD medical device—the device is intended for performance evaluation only |
| 11 | For a sterile device, the word ‘STERILE’ and information about the method that was used to sterilise the device |
| 12 | For a device that is intended by the manufacturer to be supplied in a sterile state: (a) an indication that the device is sterile; and (b) information about what to do if sterile packaging is damaged; and (c) if appropriate, instructions for resterilisation of the device |
| 13 | For a medical device that is intended by the manufacturer to be sterilised before use—instructions for cleaning and sterilising the device which, if followed, will ensure that the device continues to comply with the applicable provisions of the essential principles |
| 14 | Any special operating instructions for the use of the device |
| 15 | Information to enable the user to verify whether the device is properly installed and whether it can be operated safely and correctly, including details of calibration (if any) needed to ensure that the device operates properly and safely during its intended life |
| 16 | Information about the nature and frequency of regular and preventative maintenance of the device, including information about the replacement of consumable components of the device during its intended life |
| 17 | Information about any treatment or handling needed before the device can be used |
| 18 | For a device that is intended by the manufacturer to be installed with, or connected to, another medical device or other equipment so that the device can operate as required for its intended purpose—sufficient information about the device to enable the user to identify the appropriate other medical device or equipment that will ensure a safe combination |
| 19 | For an implantable medical device—information about any risks associated with its implantation |
| 20 | For a reusable device: (a) information about the appropriate processes to allow reuse of the device (including information about cleaning, disinfection, packaging and, if appropriate, resterilisation of the device); and (b) an indication of the number of times the device may be safely reused |
| 21 | For a medical device that is intended by the manufacturer to emit radiation for medical purposes—details of the nature, type, intensity and distribution of the radiation emitted |
| 22 | Information about precautions that should be taken by a patient and the user if the performance of the device changes |
| 23 | Information about precautions that should be taken by a patient and the user if it is reasonably foreseeable that use of the device will result in the patient or user being exposed to adverse environmental conditions |
| 24 | Adequate information about any medicinal product that the device is designed to administer, including any limitations on the substances that may be administered using the device |
| 25 | Information about any medicine (including any stable derivative of human blood or blood plasma) that is incorporated, or is intended to be incorporated, into the device as an integral part of the device |
| 25A | For a medical device, other than an IVD medical device, information about any tissues, tissue derivatives, cells or substances of animal origin that have been rendered non‑viable, or tissues, cells or substances of microbial or recombinant origin that are included in the device |
| 26 | Information about precautions that should be taken by a patient and the user if there are special or unusual risks associated with the disposal of the device |
| 27 | Information about the degree of accuracy claimed if the device has a measuring function |
| 28 | Information about any particular facilities required for use of the device or any particular training or qualifications required by the user of the device |
| 29 | For an IVD medical device, information (including, to the extent practicable, drawings and diagrams) about the following: (a) the scientific principle (the ‘test principle’) on which the performance of the IVD medical device relies; (b) specimen type, collection, handling and preparation; (c) reagent description and any limitations (for example, use with a dedicated instrument only); |
| | (d) assay procedure including calculations and interpretation of results; (e) interfering substances and their effect on the performance of the assay; |
| | (f) analytical performance characteristics, such as sensitivity, specificity, accuracy and precision; (g) clinical performance characteristics, such as sensitivity and specificity; (h) reference intervals, if appropriate; (i) any precautions to be taken in relation to substances or materials that present a risk of infection |
13A Patient implant cards and patient information leaflets
13A.1 Scope of clauses 13A.2 to 13A.4
Clauses 13A.2 to 13A.4 apply to a medical device that is:
(a) an implantable medical device or an active implantable medical device; and
(b) not a suture, staple, dental filling, dental brace, tooth crown, screw, wedge, plate, wire, pin, clip or connector.
13A.2 Patient implant cards for implantable devices
(1) A card (a patient implant card) that meets the requirements of subclause (2) and clause 13A.4 must be provided with the medical device.
(2) The card must include the information mentioned in the following table.
| Information to be included in a patient implant card |
| Item | Information to be included |
| 1 | (a) the name of the device; and (b) the model of the device; and (c) the batch code, lot number or serial number of the device; and (d) the unique device identifier of the device (if any) |
| 2 | The manufacturer’s name, address and website |
13A.3 Patient information leaflets for implantable devices
(1) A leaflet (a patient information leaflet) that meets the requirements of subclauses (2) to (4) and clause 13A.4 must be provided with the medical device.
(2) The leaflet must include the following information:
(a) information identifying the device, or the kind of device;
(b) the intended purpose of the device;
(c) information explaining how to use the device safely;
(d) other information about the device that the manufacturer considers would be useful for patients.
(3) In particular, the leaflet must include the information mentioned in the following table.
| Information to be included in patient information leaflet |
| Item | Information to be included |
| 1 | (a) the name of the device; and (b) the model of the device |
| 2 | (a) the intended purpose of the device; and (b) the kind of patient on whom the device is intended to be used |
| 3 | Any special operating instructions for the use of the device |
| 4 | (a) the intended performance of the device; and (b) any undesirable side effects that could be caused by use of the device |
| 5 | Any residual risks that could arise due to any shortcomings of the protection measures adopted as mentioned in subclause 2(2) |
| 6 | (a) warnings about risks that could arise from the interaction of the device with other equipment; and (b) precautions and other measures that, because of those risks, should be taken by the patient or a health professional Example 1: The risk of electrical interference from electro‑surgical devices. Example 2: The risk of magnetic field interference from magnetic resonance imaging devices. |
| 7 | (a) the nature and frequency of regular or preventative examination, monitoring or maintenance of the device that should be undertaken; and (b) symptoms that could indicate that the device is malfunctioning; and (c) precautions and other measures that should be taken by the patient if the performance of the device changes or the patient experiences any of the symptoms mentioned in paragraph (b); and (d) the expected device lifetime; and (e) anything that could shorten or lengthen the device lifetime; and (f) precautions and other measures that should be taken at, or near, the end of the expected device lifetime; and (g) other circumstances in which the patient should contact a health professional in relation to the operation of the device |
| 8 | (a) the materials and substances included in the device; and (b) any manufacturing residuals that could pose a risk to the patient |
| 9 | (a) a notice that any serious incident that occurs in relation to the device should be reported to the manufacturer and to the Therapeutic Goods Administration; and (b) the address of the Therapeutic Goods Administration’s website |
(4) The information in the leaflet must be written in a way that is readily understood by patients.
13A.4 Form of patient implant cards and patient information leaflets
(1) The information required by clause 13A.2 or 13A.3 to be included in a patient implant card or patient information leaflet:
(a) must be included in English; and
(b) may also be included in any other language.
Note: The information may also include diagrams or drawings.
(2) Any number, letter, symbol, or letter or number in a symbol, used in a patient implant card or patient information leaflet must be:
(a) legible; and
(b) at least 1 millimetre high.
14 Clinical evidence
Every medical device requires clinical evidence, appropriate for the use and classification of the device, demonstrating that the device complies with the applicable provisions of the essential principles.
Note: See regulation 3.11 and the clinical evaluation procedures.
15 Principles applying to IVD medical devices only
(1) An IVD medical device must be designed and manufactured in a way in which the analytical and clinical characteristics support the intended use, based on appropriate scientific and technical methods.
(2) An IVD medical device must be designed in a way that addresses accuracy, precision, sensitivity, specificity, stability, control of known relevant interference and measurement of uncertainty, as appropriate.
(3) If performance of an IVD medical device depends in whole or part on the use of calibrators or control materials, the traceability of values assigned to the calibrators or control material must be assured through a quality management system.
(4) An IVD medical device must, to the extent reasonably practicable, include provision for the user to verify, at the time of use, that the device will perform as intended by the manufacturer.
(5) An IVD medical device for self‑testing must be designed and manufactured so that it performs appropriately for its intended purpose, taking into account the skills and the means available to users and the influence resulting from variation that can reasonably be anticipated in the user’s technique and environment.
(6) The information and instructions provided by the manufacturer of an IVD medical device for self‑testing must be easy for the user to understand and apply.
(7) An IVD medical device for self‑testing must be designed and manufactured in a way that reduces, to the extent practicable, the risk of error in the use of the device, the handling of the sample and the interpretation of results.
Schedule 2—Classification rules for medical devices other than IVD medical devices
(regulation 3.2)
Part 1—Interpretation
1.1 Transient, short‑term and long‑term use
For this Schedule:
(a) a medical device is intended for transient use if the manufacturer intends the device to be used continuously for less than 60 minutes; and
(b) a medical device is intended for short‑term use if the manufacturer intends the device to be used continuously for at least 60 minutes but not more than 30 days; and
(c) a medical device is intended for long‑term use if the manufacturer intends the device to be used continuously for more than 30 days.
Part 2—Rules for non‑invasive medical devices
2.1 Non‑invasive medical devices—general
A non‑invasive medical device is classified as Class I, unless the device is classified at a higher level under another clause in this Part or in Part 4 or 5 of this Schedule.
2.2 Non‑invasive medical devices intended to channel or store blood, etc
(1) This clause applies to:
(a) a non‑invasive medical device that is intended by the manufacturer to be used to channel or store blood or body liquids that are to be infused, administered or introduced into a patient; and
(b) a non‑invasive medical device that is intended by the manufacturer to be used to store an organ, part of an organ or body tissue that is to be later introduced into a patient; and
(c) a non‑invasive medical device that:
(i) is intended by the manufacturer to be used to channel or store a liquid or gas that is to be infused, administered or introduced into a patient; and
(ii) may be connected to an active medical device classified as Class IIa or higher.
(2) The device is classified as Class IIa.
2.3 Non‑invasive medical devices intended to modify the biological or chemical composition of blood, etc
(1) Subject to subclause (2), a non‑invasive medical device that is intended by the manufacturer to be used to modify the biological or chemical composition of blood, other body liquids, or other liquids intended to be infused into a patient, is classified as Class IIb.
(2) If the treatment for which the device is designed consists of filtration, centrifugation or exchanges of gas or heat, the device is classified as Class IIa.
2.4 Non‑invasive medical devices intended to have contact with injured skin
(1) This clause applies to a non‑invasive medical device that is intended by the manufacturer to be used in contact with injured skin (including a device the principal intention of which is to manage the micro‑environment of a wound).
(2) Subject to subclauses (3) and (4), the device is classified as Class IIa.
(3) If the device is intended to be used:
(a) as a mechanical barrier; or
(b) for compression; or
(c) for the absorption of exudates;
the device is classified as Class I.
(4) If the device is intended to be used principally for wounds that have breached the dermis and the wounds can only heal by secondary intent, the device is classified as Class IIb.
Part 3—Rules for invasive medical devices and implantable medical devices
3.1 Invasive medical devices intended to be used by penetration of body orifices
(1) This clause applies to an invasive medical device (other than a surgically invasive medical device) that is intended by the manufacturer to be used to penetrate a body orifice of a patient.
(2) If the device is not intended to be connected to an active medical device, the following rules apply:
(a) if the device is intended for transient use, the device is classified as Class I;
(b) if the device is intended for short‑term use:
(i) the device is classified as Class IIa; or
(ii) if the device is intended to be used in the oral cavity as far as the pharynx, in an ear canal up to the ear drum, or in a nasal cavity—the device is classified as Class I;
(c) if the device is intended for long‑term use:
(i) the device is classified as Class IIb; or
(ii) if the device is intended to be used in the oral cavity as far as the pharynx or in an ear canal up to the ear drum, or the device is intended to be used in a nasal cavity and the device is not liable to be absorbed by the mucous membrane—the device is classified as Class IIa.
(3) If the device is intended to be connected to an active medical device that is classified as Class IIa or higher, the device is classified as Class IIa.
3.2 Surgically invasive medical devices intended for transient use
(1) This clause applies to a surgically invasive medical device that is intended for transient use.
(2) Subject to subclauses (3) to (5), the device is classified as Class IIa.
(3) If the device is intended by the manufacturer specifically to be used to diagnose, monitor, control or correct a defect of the heart, or the central circulatory system, of a patient through direct contact with these parts of the body, the device is classified as Class III.
(4) If the device is a reusable surgical instrument, the device is classified as Class I.
(5) If:
(a) the device is intended by the manufacturer to be used to supply energy in the form of ionising radiation; or
(b) the device is intended by the manufacturer to have a biological effect; or
(c) the device is intended by the manufacturer to be wholly, or mostly, absorbed by the patient’s body; or
(d) the device is intended by the manufacturer to be used to administer medicine to a patient by means of a delivery system, and the administration is potentially hazardous to the patient having regard to the characteristics of the device;
the device is classified as Class IIb.
3.3 Surgically invasive medical devices intended for short‑term use
(1) This clause applies to a surgically invasive medical device that is intended for short‑term use.
(2) Subject to subclauses (3) and (4), the device is classified as Class IIa.
(3) If:
(a) the device is intended by the manufacturer to be used to supply energy in the form of ionising radiation; or
(b) the device is intended by the manufacturer to undergo a chemical change in a patient’s body (other than a device that is intended by the manufacturer to be placed in the teeth); or
(c) the device is intended by the manufacturer to administer medicine;
the device is classified as Class IIb.
Note for paragraph (b): A device that is intended by the manufacturer to be placed in the teeth, and to undergo a chemical change in the body, is classified as Class IIa—see subclause (2).
(4) If the device is intended by the manufacturer:
(a) specifically to be used to diagnose, monitor, control or correct a defect of the heart, or the central circulatory system, of a patient through direct contact with these parts of the body; or
(b) specifically to be used in direct contact with the central nervous system of a patient; or
(c) to have a biological effect; or
(d) to be wholly, or mostly, absorbed by a patient’s body;
the device is classified as Class III.
(5) For this clause, a medical device that is intended by the manufacturer to be placed in the teeth includes a medical device that is intended by the manufacturer to penetrate a tooth, but does not include a medical device that is intended by the manufacturer to penetrate a tooth and enter the gum or bone beyond the tooth.
3.4 Surgically invasive medical devices intended for long‑term use and implantable medical devices
(1) This clause applies to:
(a) a surgically invasive medical device that is intended for long‑term use; and
(b) an implantable medical device.
(2) Subject to subclauses (3), (4) and (4A), the device is classified as Class IIb.
(3) If the device is intended by the manufacturer to be placed in the teeth of a patient, the device is classified as Class IIa.
(4) If the device is intended by the manufacturer:
(a) to be used in direct contact with the heart, the central circulatory system or the central nervous system of a patient; or
(b) to have a biological effect; or
(c) to be wholly, or mostly, absorbed by a patient’s body; or
(d) to undergo a chemical change in a patient’s body (other than a device that is intended by the manufacturer to be placed in the teeth); or
(e) to be used to administer medicine;
the device is classified as Class III.
Note for paragraph (d): A device that is intended by the manufacturer to be placed in the teeth, and to undergo a chemical change in the body, is classified as Class IIa—see subclause (3).
(4A) The device is classified as Class III if it is:
(a) a joint replacement medical device; or
(b) surgical mesh.
(5) For this clause, a medical device that is intended by the manufacturer to be placed in the teeth includes a medical device that is intended by the manufacturer to penetrate a tooth, but does not include a medical device that is intended by the manufacturer to penetrate a tooth and enter the gum or bone beyond the tooth.
Part 4—Special rules for active medical devices
4.1 Active medical devices—general
An active medical device is classified as Class I, unless the device is classified at a higher level under another clause in this Part or in Part 2, 3 or 5.
4.2 Active medical devices for therapy
(1) Subject to subclause (2), an active medical device for therapy that is intended by the manufacturer to be used to administer energy to a patient, or exchange energy to or from a patient, is classified as Class IIa.
(2) If the device is of a kind such that the administration or exchange of energy occurs in a potentially hazardous way, having regard to the nature, density and site of application of the energy, the device is classified as Class IIb.
(3) An active medical device that is intended by the manufacturer to be used to control or monitor, or directly influence, the performance of an active medical device for therapy of the kind mentioned in subclause (2) is classified as Class IIb.
4.3 Active medical devices for diagnosis
(1) This clause applies to an active medical device for diagnosis.
(2) If:
(a) the device is intended by the manufacturer to be used to supply energy that will be absorbed by a patient’s body (other than a device that is intended only to illuminate the patient’s body in the visible spectrum); or
(b) the device is intended by the manufacturer to be used to image in vivo distribution of radiopharmaceuticals in a patient; or
(c) the device is intended by the manufacturer to be used to allow direct diagnosis or monitoring of vital physiological processes of a patient (other than a device of a kind mentioned in paragraph (3)(a));
the device is classified as Class IIa.
Note for paragraph (a): A device that is intended only to illuminate the patient’s body in the visible spectrum is classified as Class I—see clause 4.1 of this Schedule.
(3) If:
(a) the device is intended by the manufacturer specifically to be used to monitor vital physiological parameters of a patient, and the nature of the variations monitored is of a kind that could result in immediate danger to the patient (for example, variations in cardiac performance, respiration, activity of the central nervous system); or
(b) the device is intended by the manufacturer to emit ionising radiation and to be used for diagnostic or therapeutic interventional radiology; or
(c) the device is intended by the manufacturer to be used to control or monitor, or directly influence, the performance of a device of the kind mentioned in paragraph (b);
the device is classified as Class IIb.
4.4 Active medical devices intended to administer or remove medicines, etc from a patient’s body
(1) Subject to subclause (2), an active medical device that is intended by the manufacturer to be used to administer medicine, body liquids or other substances to a patient, or to remove medicine, body liquids or other substances from a patient, is classified as Class IIa.
(2) If the device is of a kind such that the administration or removal of the medicine, body liquids or other substances is potentially hazardous to the patient, having regard to the nature of the substances involved, the part of the patient’s body concerned, and the characteristics of the device, the device is classified as Class IIb.
Part 5—Special rules for particular kinds of medical devices
5.1 Medical devices incorporating a medicine
(1) This clause applies to a medical device of any kind that incorporates, or is intended to incorporate, as an integral part, a substance that:
(a) if used separately, would be a medicine; and
(b) is liable to act on a patient’s body with action ancillary to that of the device.
(2) The device is classified as Class III.
(3) For the purposes of this clause, any stable derivative of human blood or human plasma is considered to be a medicine.
5.2 Medical devices intended for contraception or prevention of sexually transmitted diseases
(1) Subject to subclause (2), a medical device that is intended by the manufacturer to be used for contraception, or the prevention of sexually transmitted diseases, is classified as Class IIb.
(2) If the device is an implantable medical device or an invasive medical device that is intended for long‑term use, the device is classified as Class III.
5.3 Medical devices intended for disinfecting, cleaning, etc
(1) A medical device that is intended by the manufacturer specifically to be used for disinfecting, cleaning, rinsing or hydrating contact lenses is classified as Class IIb.
(2) A medical device that is intended by the manufacturer specifically to be used for disinfecting another medical device is classified as Class IIb.
(3) This clause does not apply to a medical device that is intended by the manufacturer to be used only to clean another medical device (other than contact lenses) by means of physical action.
Note: A medical device of the kind described in subclause (3) is classified as Class I—see clause 2.1 of this Schedule.
5.4 Non‑active medical devices intended to record X‑ray diagnostic images
A non‑active medical device that is intended by the manufacturer to be used to record X‑ray diagnostic images is classified as Class IIa.
5.5 Medical devices containing non‑viable animal tissues, cells or other substances, or microbial or recombinant tissues, cells or other substances
(1) This clause applies to a medical device if the device contains:
(a) tissues, cells or substances of animal origin that have been rendered non‑viable, or tissues, cells or substances of microbial or recombinant origin; or
(b) a combination of tissues, cells or substances of the kind described in paragraph (a).
(2) The device is classified as Class III, unless:
(a) the device contains only tissues, cells or substances of animal origin that have been rendered non‑viable; and
(b) the device is intended by the manufacturer to come into contact with intact skin only.
Note: A medical device that conforms with the description in paragraphs (2)(a) and (b) is classified as Class I under clause 2.1 of this Schedule.
5.6 Medical devices that are blood bags
A medical device that is a blood bag is classified as Class IIb.
5.7 Active implantable medical devices
(1) An active implantable medical device is classified as Class AIMD.
(2) An implantable accessory to an active implantable medical device is classified as Class III.
(3) An active medical device that is intended by the manufacturer to be used to control or monitor, or directly influence, the performance of an active implantable medical device is classified as Class III.
5.8 Medical devices intended for export only
Despite any other classification in this Schedule, a medical device that is intended by the manufacturer to be for export only is classified as Class I.
5.9 Medical devices that are mammary implants
A medical device that is a mammary implant is classified as Class III.
Schedule 2A—Classification rules for IVD medical devices
(regulation 3.2)
1.1 Detection of transmissible agents posing high public health risk
An IVD medical device intended to be used for any of the following purposes is classified as a Class 4 IVD medical device or a Class 4 in‑house IVD medical device:
(a) to detect the presence of, or exposure to, transmissible agents in blood, blood components, blood products, cells, tissues or organs or any derivatives of these products of human or animal origin, in order to assess their suitability for transfusion or transplantation;
(b) to detect the presence of, or exposure to, a transmissible agent that causes a serious disease with a high risk of propagation in Australia.
1.2 Detection of red blood cell antigens and antibodies and non‑red cell typing
(1) An IVD medical device is classified as a Class 3 IVD medical device or a Class 3 in‑house IVD medical device if:
(a) the device is intended to be used for detection of biological markers in order to assess the immunological compatibility of blood, blood components, blood products, cells, tissues or organs that are intended for transfusion or transplantation; and
(b) the device is not a device mentioned in subclause (2).
(2) An IVD medical device intended to detect any of the following markers mentioned for the following blood group systems is classified as a Class 4 IVD medical device or a Class 4 in‑house IVD medical device:
(a) ABO system—ABO1 (A), ABO2 (B), ABO3 (AB);
(b) Rhesus system—RH1 (D), RH2 (C), RH3 (E), RH4 (c), RH5 (e);
(c) Kell system—KEL1 (K);
(d) Kidd system—JK1 (Jka), JK2 (Jkb);
(e) Duffy system—FY1 (Fya), FY2 (Fyb).
1.3 Detection of transmissible agents or biological characteristics posing moderate public health risk or high personal risk
An IVD medical device is classified as a Class 3 IVD medical device or a Class 3 in‑house IVD medical device if it is intended for any of the following uses:
(a) detecting the presence of, or exposure to, a sexually transmitted agent;
(b) detecting the presence in cerebrospinal fluid or blood of an infectious agent with a risk of limited propagation;
(c) detecting the presence of an infectious agent, if there is a significant risk that an erroneous result would cause death or severe disability to the individual or foetus being tested;
(d) pre‑natal screening of women in order to determine their immune status towards transmissible agents;
(e) determining infective disease status or immune status, if there is a risk that an erroneous result will lead to a patient management decision resulting in an imminent life‑threatening situation for the patient;
(f) the selection of patients:
(i) for selective therapy and management; or
(ii) for disease staging; or
(iii) in the diagnosis of cancer;
(g) human genetic testing;
(h) to monitor levels of medicines, substances or biological components, when there is a risk that an erroneous result will lead to a patient management decision resulting in an immediate life‑threatening situation for the patient;
(i) the management of patients suffering from a life‑threatening infectious disease;
(j) screening for congenital disorders in a foetus.
Note for paragraph (f): An IVD medical device would fall into Class 2 under clause 1.7 if:
(a) a therapy decision would usually be made only after further investigation; or
(b) the device is used for monitoring.
1.4 IVD medical devices for self‑testing
An IVD medical device for self‑testing is classified as a Class 3 IVD medical device unless:
(a) the result of the examination is not determining a serious condition, ailment or defect; or
(b) the examination is preliminary and follow‑up additional testing is required.
1.5 Non assay‑specific quality control material
Despite clauses 1.1 to 1.4, an IVD medical device that is intended to be used as non assay‑specific quality control material is classified as a Class 2 IVD medical device or a Class 2 in‑house IVD medical device.
1.6 Reagents, instruments etc
(1) A reagent or other article that possesses specific characteristics, intended by the manufacturer, to make it suitable for in vitro diagnostic procedures related to a specific examination is classified as a Class 1 IVD medical device or a Class 1 in‑house IVD medical device.
(2) Despite clauses 1.1 to 1.5, the following IVD medical devices are classified as Class 1 IVD medical devices or Class 1 in‑house IVD medical devices:
(a) an instrument, intended by the manufacturer, to be specifically used for in vitro diagnostic procedures;
(b) a specimen receptacle, other than a specimen receptacle that is intended for use in self‑testing;
(c) a microbiological culture medium.
(3) In this clause:
examination means a set of operations having the object of determining the value or characteristics of a property.
Note: In some disciplines (for example, microbiology) an examination is the combination of a number of tests, observations or measurements.
specimen receptacle means a device, whether vacuum‑type or not, specifically intended by its manufacturer for the primary containment and preservation of a specimen derived from the human body for the purpose of in vitro diagnostic examination.
Note 1: A specimen receptacle is considered to be an IVD medical device.
Note 2: A product for general laboratory use is not an IVD medical device unless the product is specifically intended by its manufacturer to be used for in vitro diagnostic examination.
1.7 Other IVD medical devices are Class 2 IVD medical devices
An IVD medical device not mentioned in this Schedule is classified as a Class 2 IVD medical device or a Class 2 in‑house IVD medical device.
1.8 IVD medical devices intended for export only
Despite clauses 1.1 to 1.7, an IVD medical device is classified as a Class 1 IVD medical device if it is intended by the manufacturer for export only.
Schedule 3—Conformity assessment procedures
(regulation 3.4)
Part 1—Full quality assurance procedures
1.1 Overview
The conformity assessment procedures set out in this Part provide for the manufacturer of a kind of medical device:
(a) to:
(i) implement a quality management system for the design, production, packaging, labelling and final inspection of the kind of device; and
(ii) arrange for assessment of the system by the Secretary or an Australian conformity assessment body; and
(b) for a Class 4 IVD medical device, Class 4 in‑house IVD medical device, Class AIMD medical device or Class III medical device—to arrange for examination of the design of the kind of device by the Secretary or an Australian conformity assessment body; and
(c) to allow the Secretary or an Australian conformity assessment body to monitor the operation of, and carry out inspections of, the system; and
(d) to make a declaration of conformity in relation to the kind of device; and
(e) to:
(i) notify the Secretary or an Australian conformity assessment body of any change to the system, or to the kinds of devices to which the system is to be applied; and
(ii) arrange for assessment of any such change by the Secretary or an Australian conformity assessment body; and
(f) to establish and keep up‑to‑date a post‑market monitoring, reporting and corrective action system.
Note: See Division 3.2 in relation to the kinds of medical devices to which these conformity assessment procedures may be applied.
1.2 References to kinds of medical devices
A reference in this Part to a kind of medical device includes a reference to an individual medical device.
1.3 Implementation and assessment of quality management system
(1) The manufacturer of a kind of medical device must:
(a) implement a quality management system for the design, production, packaging, labelling and final inspection of the kind of device; and
(b) arrange for assessment of the system by the Secretary or an Australian conformity assessment body.
(2) For the purpose of enabling the assessment to be carried out, the manufacturer must have available, in writing, the following information and undertakings:
(a) the name and business address of the manufacturer;
(b) details of each manufacturing site where the system is to be applied;
(c) all relevant information about the kind of medical devices to which the system is to be applied;
(d) the documentation in relation to the system;
(e) an undertaking by the manufacturer to continue to comply with the requirements of the system after assessment;
(f) an undertaking by the manufacturer to ensure that the system is at all times adequate and efficacious;
(g) an undertaking by the manufacturer:
(i) if the manufacturer arranged for assessment of the system by the Secretary—to notify the Secretary, or the person in relation to whom the kind of device is included in the Register, of any information of the kind mentioned in paragraph 1.4(3A)(a) or (b) that the manufacturer becomes aware of in relation to the kind of medical device; or
(ii) if the manufacturer arranged for assessment of the system by an Australian conformity assessment body—to notify the body, or the person in relation to whom the kind of device is included in the Register, of any information of the kind mentioned in paragraph 1.4(3A)(a) or (b) that the manufacturer becomes aware of in relation to the kind of medical device.
1.4 Requirements of quality management system
(1) A quality management system that is to be assessed under clause 1.3 must meet the requirements of this clause.
(2) The system must be of a kind such that its application will ensure that each medical device to which the system is applied complies with the applicable provisions of the essential principles, the classification rules, and these conformity assessment procedures, at each stage, from the design of the device until its final inspection before being supplied.
(3) The system must include post‑marketing requirements under which the manufacturer of a medical device to which the system is applied is required:
(a) to systematically review experience gained, post‑production, in relation to medical devices of that kind; and
(b) to implement appropriate means to apply any necessary corrective action in relation to the design or production of such devices; and
(c) to:
(i) if the manufacturer arranged for assessment of the system under clause 1.3 by the Secretary—notify the Secretary, or the person in relation to whom the kind of device is included in the Register, as soon as practicable after becoming aware of information referred to in subclause (3A); or
(ii) if the manufacturer arranged for assessment of the system under clause 1.3 by an Australian conformity assessment body—notify the body, or the person in relation to whom the kind of device is included in the Register, as soon as practicable after becoming aware of information referred to in subclause (3A).
Note: See also paragraph 41FN(3)(d) and section 41MP of the Act in relation to the requirement to give certain information about a medical device to the Secretary.
(3A) For the purposes of subparagraphs (3)(c)(i) and (ii), the information is the following:
(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 or instructions for use of the kind of device, or in the advertising material for 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 mentioned in subparagraph (a)(i) that has led the manufacturer to take steps to recall devices of that kind that have been distributed.
(4) Each requirement of the system must be documented in a systematic and orderly way in the form of written policies and procedures (for example, as quality programs, quality plans, quality manuals or quality records).
(5) The documentation of the system must include adequate information in relation to the following matters:
(a) the manufacturer’s quality objectives;
(b) the organisation of the manufacturer’s business, including, in particular, a description of the following:
(i) the organisational structure of the business;
(ii) the responsibilities of managerial staff and their authority in relation to the quality of the design and production of medical devices manufactured by the manufacturer;
(iii) the methods of monitoring whether the system is operating effectively, in particular, whether the desired quality of design and product is being achieved and how products that fail to meet the desired quality are controlled;
(c) the design of the kind of medical device to which the system is to be applied, including, in particular, the following:
(i) details of the processes, systems and measures used for controlling, monitoring and verifying that at each stage of the design process, the device complies with the applicable provisions of the essential principles;
(ii) a general description of the kind of device, and of any variants of the kind of device, that the manufacturer plans to manufacture;
(iii) details of the design specifications for the kind of device, including:
(A) any medical device standard or conformity assessment standard that has been applied to the device; and
(B) the results of the risk analysis carried out; and
(C) if no medical device standard or conformity assessment standard, or part only of such a standard, has been applied to the device—the solutions adopted to ensure that each device complies with the applicable provisions of the essential principles;
(iv) for a kind of device that is intended by the manufacturer to be connected to another device—evidence demonstrating that the device will comply with the applicable provisions of the essential principles when it is connected to the other device and both devices are being used for their intended purposes;
(v) a statement indicating whether or not the kind of device incorporates, or is intended to incorporate, as an integral part, a substance mentioned in clause 7.4 of the essential principles, and, for a device that will do so, data derived from tests conducted in relation to the device and the substance, and their interaction;
(vi) a statement indicating whether or not the device, other than an IVD medical device, contains tissues, cells or substances of animal origin that have been rendered non‑viable, or tissues, cells or substances of microbial or recombinant origin;
(via) for an IVD medical device—a statement indicating whether or not the device contains viable tissues, cells, or substances of human or animal origin;
(vii) a copy of the clinical evidence, in relation to the kind of device, required by the clinical evaluation procedures;
(viii) a copy of the information to be provided with the kind of device;
(d) the inspection and quality assurance techniques to be applied in the production of the kind of medical device to which the system is to be applied, including, in particular, information about the following:
(i) the processes and procedures to be used (particularly in relation to sterilisation) and the documents relating to those processes and procedures;
(ii) the procedures to be used for purchasing goods or services in relation to the production of the kind of device and the documents relating to those procedures;
(iii) product identification procedures to be prepared and kept up‑to‑date from drawings, specifications or other documents at each stage of production;
(e) the tests or trials to be carried out before, during and after production of the kind of medical device to which the system is to be applied, including, in particular, information about:
(i) the frequency with which the tests or trials are to be carried out; and
(ii) the equipment (including the traceability of the calibration of the equipment) used, or to be used, to carry out the tests or trials;
(f) the system for reviewing experience gained in the post‑production phase in relation to the kind of medical device to which the quality management system has been applied, and the means by which any necessary corrective action will be applied in relation to the design or production of such devices;
(g) whether a conformity assessment standard has been applied to the system and, if no conformity assessment standard, or part only of a conformity assessment standard, has been applied to the system—the solutions adopted to ensure that the system complies with subclause (2).
1.5 Changes to quality management system or kinds of medical device to which system is to be applied
(1) This clause applies to the manufacturer of a kind of medical device if:
(a) the manufacturer has implemented, and had assessed under clause 1.3 of this Schedule, a quality management system that is to be applied to the kind of device; and
(b) after assessment, the manufacturer plans to make:
(i) a substantial change to the system; or
(ii) a change to the kinds of medical devices to which the system is to be applied.
(2) The manufacturer must:
(a) notify the Secretary or an Australian conformity assessment body, in writing, of the proposed change; and
(b) arrange for assessment of the change by the Secretary or the Australian conformity assessment body to verify whether the system, as changed, meets the requirements of clause 1.4 of this Schedule.
(3) For the purpose of enabling the assessment to be carried out, the manufacturer must have available, in writing, details of any consequential changes to the information and documentation required under subclause 1.3(2) of this Schedule in relation to the system or kinds of devices.
(4) After any change to the quality management system, the manufacturer must ensure that the changed system continues to meet the requirements of clause 1.4 of this Schedule.
1.6 Examination of design of Class 4 IVD medical device, Class 4 in‑house IVD medical device, Class AIMD medical device or Class III medical device
(1) This clause applies to the manufacturer of a Class 4 IVD medical device, a Class 4 in‑house IVD medical device, a Class AIMD medical device, or a Class III medical device, to which the quality management system that is to be assessed under clause 1.3 is to be applied.
(2) For the purpose of assessing whether the kind of medical device complies with the applicable provisions of the essential principles, the manufacturer of the device must arrange for examination by the Secretary or an Australian conformity assessment body of the design of the kind of device.
(3) For the purpose of enabling the examination to be carried out, the manufacturer must have available:
(a) information, in writing, in relation to the following matters in relation to the kind of medical device:
(i) the design;
(ii) the production process;
(iii) the intended performance; and
(b) a copy of the documentation mentioned in paragraph 1.4(5)(c) of this Schedule necessary to assess whether the kind of medical device complies with the applicable provisions of the essential principles.
(4) If, after examination by the Secretary or an Australian conformity assessment body of the design of a kind of medical device, the manufacturer makes a substantial change to the design, or the intended performance, of the kind of device, the manufacturer must:
(a) notify the Secretary or an Australian conformity assessment body, in writing, of the change; and
(b) arrange for examination of the change by the Secretary or the Australian conformity assessment body to assess whether the design, or the intended performance, of the medical device, as changed, complies with the applicable provisions of the essential principles.
(5) For the purpose of enabling an examination to be carried out under subclause (4), the manufacturer must have available, in writing, details of any consequential changes to the documentation in relation to the design of the device mentioned in paragraph 1.4(5)(c) of this Schedule.
Note: This clause need not be applied to:
(a) a Class IIb medical device—see Division 3.2, paragraphs 3.7(1)(a) and (2)(a); or
(b) a Class 3 IVD medical device—see Division 3.2, paragraph 3.7A(a); or
(c) a Class IIa medical device—see Division 3.2, paragraphs 3.8(1)(a) and (2)(a); or
(d) a Class 2 IVD medical device—see Division 3.2, paragraph 3.8A(a).
1.7 Information to be given to authorised person
(1) If requested to do so by an authorised person, the manufacturer of a kind of medical device must:
(a) give to the Secretary the following information in relation to the quality management system or the kinds of medical device to which the system is applied:
(i) a copy of the documentation mentioned in subclause 1.4(5) of this Schedule;
(ii) data in relation to the design of the kinds of medical device (for example, the results of any analysis of the device, calculations, tests);
(iii) data in relation to the manufacture of the kinds of medical device (for example, inspection reports, test data, calibration data, information about the qualifications of staff); and
(b) arrange for tests specified by the authorised person to be carried out for the purpose of checking whether the quality management system is operating effectively.
(2) If any inspections or tests are carried out by an authorised person in relation to the manufacturer’s premises, or medical devices produced by the manufacturer, the manufacturer may ask the authorised person to give to the manufacturer a report stating the findings of the inspections or tests.
1.8 Declaration of conformity
(1) The manufacturer of a kind of medical device to which a quality management system that has been assessed under clause 1.3 of this Schedule has been applied must make a declaration of conformity in relation to the kind of device.
(2) The declaration must:
(a) state that the declaration is a declaration of conformity made under clause 1.8 of Schedule 3 to the Therapeutic Goods (Medical Devices) Regulations 2002; and
(b) state the name and business address of the manufacturer of the device; and
(c) state the following information in relation to each kind of medical device to which the system has been applied:
(i) the unique product identifier (for example, the product name or model number);
(ii) the medical device classification;
(iii) the device nomenclature system code; and
(d) if the system has not been applied to all medical devices of that kind manufactured by the manufacturer—give details of the medical devices to which the system has been applied (for example, by reference to lot numbers, batches or serial numbers, or by specifying the kinds of medical devices or the times of manufacture); and
(e) state that each kind of medical device to which the system has been applied complies with the applicable provisions of the essential principles, the classification rules, and the full quality assurance procedures, at each stage, from the design of the device until its final inspection before being supplied; and
(f) state the identification number of the conformity assessment certificate, or of the Australian conformity assessment body certificate, issued in relation to the system or the kind of medical devices to which the system has been applied; and
(g) give details of any conformity assessment standard or medical device standard that has been applied to a kind of device to which the system has been applied; and
(h) be signed by a person authorised by the manufacturer; and
(i) set out the name and position of the person signing the declaration; and
(j) state the date when the declaration is signed.
1.9 Records
(1) The manufacturer of a kind of medical device to which a quality management system that has been assessed under clause 1.3 of this Schedule has been applied must keep the following records in relation to the system and the kind of device:
(a) the documentation mentioned in subclause 1.4(5) of this Schedule;
(b) details of any changes made to the system and to the information and documentation required under subclause 1.3(2) of this Schedule;
(c) if the device is a Class 4 IVD medical device, Class 4 in‑house IVD medical device, Class AIMD medical device or Class III medical device, the information and documentation required under subclause 1.6(3) of this Schedule;
(d) details of any changes made to the kind of medical device and to the documentation in relation to the design of the device mentioned in paragraph 1.4(5)(c) of this Schedule;
(e) the declaration of conformity under clause 1.8 of this Schedule;
(f) details of the systematic review carried out, post‑production, in relation to medical devices of that kind;
(g) any notice, report, certificate or other document in relation to the system issued to the manufacturer by the Secretary or an Australian conformity assessment body.
(2) The manufacturer must keep the records for at least 5 years after the manufacture of the last medical device to which the quality management system was applied.
(3) On request from the Secretary, the manufacturer must make the records available to the Secretary.
Part 2—Type examination procedures
2.1 Overview
The conformity assessment procedures set out in this Part provide for the manufacturer to arrange for examination by the Secretary or an Australian conformity assessment body of a representative sample of a kind of medical device (the type).
Note: See Division 3.2 in relation to the kinds of medical devices to which these conformity assessment procedures may be applied.
2.2 References to kinds of medical devices
A reference in this Part to a kind of medical device includes a reference to an individual medical device.
2.3 Examination of type
(1) The manufacturer of a medical device must arrange for examination of the type by the Secretary or an Australian conformity assessment body.
(2) For the purpose of enabling the examination to be carried out, the manufacturer must have available, in writing, the following information:
(a) the name and business address of the manufacturer;
(b) the documentation mentioned in subclause (3) in relation to the type.
(3) For paragraph (2)(b), the documentation must include adequate information about the design, production process and intended performance of the type, and must include, in particular, the following:
(a) a general description of the type, and of any variants of the type that the manufacturer plans to manufacture;
(b) diagrams or drawings of the design of the type, including diagrams or drawings of any components, sub‑assemblies or circuits of the type;
(c) any descriptions or explanations that are necessary to enable the diagrams or drawings mentioned in paragraph (b), or the intended operation of the type, to be properly understood;
(d) the proposed method or methods of manufacture of the type;
(e) if the type is intended by the manufacturer to be supplied in a sterile state—a description of the method used to sterilise the type;
(f) details of each medical device standard or conformity assessment standard that has been applied, wholly or in part, to the type;
(g) if no medical device standard or conformity assessment standard has been applied, or such a standard has been only partly applied, to the type—descriptions of the solutions adopted to ensure that the type complies with the applicable provisions of the essential principles;
(h) the results of any design calculations, risk analyses, investigations, technical tests, or any other tests, carried out in relation to the type;
(i) a statement indicating whether or not the type incorporates, or is intended to incorporate, as an integral part, a substance mentioned in clause 7.4 of the essential principles, and, for a type that does so, data derived from tests conducted in relation to the type and the substance, and their interaction;
(j) a statement indicating whether or not the device, other than an IVD medical device, contains tissues, cells or substances of animal origin that have been rendered non‑viable, or tissues, cells or substances of microbial or recombinant origin;
(ja) for an IVD medical device—a statement indicating whether or not the device contains viable tissues, cells, or substances of human or animal origin;
(k) a copy of the clinical evidence, in relation to the kind of device, required by the clinical evaluation procedures;
(l) a copy of the information to be provided with the type.
(4) The manufacturer must make available to the Secretary or the Australian conformity assessment body for examination:
(a) a sample of the type; and
(b) on request from the Secretary or the Australian conformity assessment body, additional samples of the type.
(5) If the type is intended by the manufacturer to be connected to another medical device, the manufacturer must, on request from the Secretary or the Australian conformity assessment body, make available to the Secretary or the Australian conformity assessment body, or arrange for the Secretary or the Australian conformity assessment body to have access to, a sample of the device.
2.4 Changes to design of medical device after examination
(1) This clause applies if, after examination by the Secretary or an Australian conformity assessment body of a type, the manufacturer of the type plans to make a substantial change to the design, or intended performance, of the kind of medical device to which the type relates.
(2) The manufacturer must:
(a) notify the Secretary or an Australian conformity assessment body, in writing, of the proposed change; and
(b) arrange for examination of the change by the Secretary or the Australian conformity assessment body to verify whether the type, as changed, meets the requirements of clause 2.3 of this Schedule.
(3) For the purpose of enabling the examination to be carried out, the manufacturer must have available, in writing, details of any consequential changes to the documentation required under subclause 2.3(3) of this Schedule in relation to the type.
2.5 Records
(1) The manufacturer of the type that has been examined under this Part must keep the following records:
(a) the documentation required under subclause 2.3(3) of this Schedule in relation to the type;
(b) details of any changes made to the type and to the documentation required under subclause 2.3(3) of this Schedule;
(c) any notice, report, certificate or other document in relation to the type issued to the manufacturer by the Secretary or an Australian conformity assessment body.
(2) The manufacturer must keep the records for at least 5 years after the manufacture of the last medical device of that type.
(3) On request from the Secretary, the manufacturer must make the records available to the Secretary.
Part 3—Verification procedures
3.1 Overview
The conformity assessment procedures set out in this Part provide for the manufacturer of a kind of medical device:
(a) to arrange for examination and testing of the kind of device by the Secretary or an Australian conformity assessment body; and
(b) to make a declaration of conformity in relation to the kind of device; and
(c) to establish and keep up‑to‑date a post‑market monitoring, reporting and corrective action system.
Note: See Division 3.2 in relation to the kinds of medical devices to which these conformity assessment procedures may be applied.
3.2 References to kinds of medical devices
A reference in this Part to a kind of medical device includes a reference to an individual medical device.
3.3 Verification of conformity
(1) The manufacturer of a medical device must arrange for examination and testing by the Secretary or an Australian conformity assessment body of each device of that kind, or a representative sample from a batch of medical devices of that kind, to verify that:
(a) for a kind of device in relation to which the type examination procedures have been applied—each device, or representative sample, conforms to the approved type; and
(b) for a kind of device to which the declaration of conformity (not requiring assessment by Secretary) procedures have been applied—each device, or representative sample, is in accordance with the technical documentation prepared under clause 6.4 of those procedures for that kind of device; and
(c) each device, or representative sample, complies with the applicable provisions of the essential principles, the classification rules and these conformity assessment procedures.
(2) For the purpose of enabling the examination and testing to be carried out, the manufacturer must have available, in writing, the following information and undertakings:
(a) the name and business address of the manufacturer;
(b) the documentation describing the manufacturing process to be used to manufacture the kind of device;
(c) a description of the procedures that have been, or will be, implemented to ensure that all devices of that kind manufactured by the manufacturer will be uniform;
(d) an undertaking to implement those procedures to ensure that all devices of that kind manufactured by the manufacturer will be uniform;
(e) an undertaking by the manufacturer:
(i) if the manufacturer arranged for examination and testing by the Secretary—to notify the Secretary, or the person in relation to whom the kind of device is included in the Register, of any information of the kind mentioned in paragraph 3.4(2A)(a) or (b) that the manufacturer becomes aware of in relation to the kind of medical device; or
(ii) if the manufacturer arranged for examination and testing by an Australian conformity assessment body—to notify the body, or the person in relation to whom the kind of device is included in the Register, of any information of the kind mentioned in paragraph 3.4(2A)(a) or (b) that the manufacturer becomes aware of in relation to the kind of medical device;
(f) for a kind of device in relation to which the type examination procedures have been applied—evidence that the device conforms to the approved type and a copy of the technical documentation required under subclause 2.3(3) of the type examination procedures for the approved type;
(g) for a kind of device to which the declaration of conformity (not requiring assessment by Secretary) procedures have been applied—a copy of the technical documentation prepared under clause 6.4 of those procedures for that kind of device.
(3) The manufacturer must make available to the Secretary or the Australian conformity assessment body for examination and testing:
(a) for a kind of device in relation to which the type examination procedures have been applied:
(i) each medical device that is to be verified in relation to the approved type; or
(ii) each medical device selected by the Secretary or the Australian conformity assessment body on a statistical basis from a uniform batch of devices that are to be verified in relation to the approved type; and
(b) for a kind of device to which the declaration of conformity (not requiring assessment by Secretary) procedures have been applied:
(i) each medical device of that kind to which those procedures have been applied; or
(ii) each medical device selected by the Secretary or the Australian conformity assessment body on a statistical basis from a uniform batch of devices of that kind to which those procedures have been applied.
3.4 Requirements of manufacturing system
(1) The manufacturer of a medical device must ensure that:
(a) for a kind of device in relation to which the type examination procedures have been applied—the process used to manufacture the device results in the device conforming to the approved type; and
(b) for a kind of device to which the declaration of conformity (not requiring assessment by Secretary) procedures have been applied—the process used to manufacture the device results in the device being in accordance with the technical documentation prepared under clause 6.4 of those procedures for that kind of device.
(2) The manufacturer of a medical device of a kind mentioned in subclause (1) must ensure that the process used to manufacture the device includes post‑marketing requirements under which the manufacturer is required:
(a) to systematically review experience gained in the post‑production phase in relation to medical devices of that kind; and
(b) to implement appropriate means to apply any necessary corrective action in relation to the design or production of such devices; and
(c) to:
(i) if the manufacturer arranged for examination and testing under clause 3.3 by the Secretary—notify the Secretary, or the person in relation to whom the kind of device is included in the Register, as soon as practicable after becoming aware of information referred to in subclause (2A); or
(ii) if the manufacturer arranged for examination and testing under clause 3.3 by an Australian conformity assessment body—notify the body, or the person in relation to whom the kind of device is included in the Register, as soon as practicable after becoming aware of information referred to in subclause (2A).
Note: See also paragraph 41FN(3)(d) and section 41MP of the Act in relation to the requirement to give certain information about a medical device to the Secretary.
(2A) For the purposes of subparagraphs (2)(c)(i) and (ii), the information is the following:
(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 mentioned in subparagraph (a)(i) that has led the manufacturer to take steps to recall devices of that kind that have been distributed.
(3) Before manufacturing a medical device of a kind mentioned in subclause (1), the manufacturer must prepare documentation describing the manufacturing process to be used to produce the device.
(4) Without limiting subclause (3), the documentation must include a description of the procedures that have been, or will be, implemented to ensure that all devices of that kind manufactured by the manufacturer will be uniform.
3.5 Declaration of conformity
(1) The manufacturer of a Class AIMD medical device, Class III medical device or Class IIb medical device that has been verified under this Part must make a declaration of conformity in relation to the kind of device.
Note: This clause need not be applied to the following kinds of medical devices if the declaration of conformity (not requiring assessment by Secretary) procedures have been applied to the device:
(a) a Class IIa medical device (see Division 3.2, subparagraph 3.8(1)(b)(i));
(b) a Class I medical device that has a measuring function (see Division 3.2, paragraph 3.9(3)(a)).
(2) The declaration must:
(a) state that the declaration is a declaration of conformity made under clause 3.5 of Schedule 3 to the Therapeutic Goods (Medical Devices) Regulations 2002; and
(b) state the name and business address of the manufacturer of the device; and
(c) state the following information in relation to each device that has been verified:
(i) the unique product identifier (for example, the product name or model number);
(ii) the medical device classification;
(iii) the device nomenclature system code; and
(d) if the verification does not relate to all medical devices of that kind manufactured by the manufacturer—give details of the medical devices to which the verification relates (for example, by reference to lot numbers, batches or serial numbers, or by specifying the kinds of medical devices or the times of manufacture); and
(e) for a kind of device in relation to which the type examination procedures have been applied:
(i) state the identification number of the conformity assessment certificate, or of the Australian conformity assessment body certificate, issued in relation to the approved type; and
(ii) state that the kind of device conforms to the approved type; and
(f) state that each kind of medical device or batch of devices complies with the applicable provisions of the essential principles and the classification rules;
(g) state the basis on which the declaration is made; and
(h) give details of any conformity assessment standard or medical device standard that has been applied to the kind of device or the processes used to manufacture the device; and
(i) be signed by a person authorised by the manufacturer; and
(j) set out the name and position of the person signing the declaration; and
(k) state the date when the declaration is signed.
3.6 Records
(1) The manufacturer of a kind of medical device that has been verified under this Part must keep the following records:
(a) the documentation mentioned in subclause 3.4(3) of this Schedule;
(b) for a Class AIMD medical device, Class III medical device or Class IIb medical device—the declaration of conformity under clause 3.5 of this Schedule;
(c) any notice, report, certificate or other document in relation to the device, or a batch of devices that includes the device, issued to the manufacturer by the Secretary or an Australian conformity assessment body.
(2) The manufacturer must keep the records for at least 5 years after the manufacture of the last medical device to which the verification relates.
(3) On request from the Secretary, the manufacturer must make the records available to the Secretary.
Part 4—Production quality assurance procedures
4.1 Overview
The conformity assessment procedures set out in this Part provide for the manufacturer of a kind of medical device:
(a) to:
(i) implement a quality management system for the production and final inspection of the kind of device; and
(ii) arrange for assessment of the system by the Secretary or an Australian conformity assessment body; and
(b) to allow the Secretary or an Australian conformity assessment body to monitor the operation of, and carry out inspections of, the system; and
(c) to make a declaration of conformity in relation to the kind of device; and
(d) to:
(i) notify the Secretary or an Australian conformity assessment body of any change to the system; and
(ii) arrange for assessment of any such change by the Secretary or an Australian conformity assessment body; and
(e) to establish and keep up‑to‑date a post‑market monitoring, reporting and corrective action system.
Note: See Division 3.2 in relation to the kinds of medical devices to which these conformity assessment procedures may be applied.
4.2 References to kinds of medical devices
A reference in this Part to a kind of medical device includes a reference to an individual medical device.
4.3 Implementation and assessment of production quality management system
(1) The manufacturer of a medical device must:
(a) implement a quality management system for the production and final inspection of the kind of device; and
(b) arrange for assessment of the system by the Secretary or an Australian conformity assessment body.
(2) For the purpose of enabling the assessment to be carried out, the manufacturer must have available, in writing, the following information and undertakings:
(a) the name and business address of the manufacturer;
(b) details of each manufacturing site where the system is to be applied;
(c) all relevant information about the kinds of medical devices to which the system is to be applied;
(d) the documentation in relation to the system;
(e) an undertaking by the manufacturer to continue to comply with the requirements of the system after assessment;
(f) an undertaking by the manufacturer to ensure that the system is at all times adequate and efficacious;
(g) for a kind of device in relation to which the type examination procedures have been applied—evidence that the device conforms to the approved type and a copy of the technical documentation required under subclause 2.3(3) of the type examination procedures for the approved type;
(h) for a kind of device to which the declaration of conformity (not requiring assessment by Secretary) procedures have been applied—a copy of the technical documentation prepared under clause 6.4 of those procedures for that kind of device;
(i) an undertaking by the manufacturer:
(i) if the manufacturer arranged for assessment of the system by the Secretary—to notify the Secretary, or the person in relation to whom the kind of device is included in the Register, of any information of the kind mentioned in paragraph 4.4(3A)(a) or (b) that the manufacturer becomes aware of in relation to the kind of medical device; or
(ii) if the manufacturer arranged for assessment of the system by an Australian conformity assessment body—to notify the body, or the person in relation to whom the kind of device is included in the Register, of any information of the kind mentioned in paragraph 4.4(3A)(a) or (b) that the manufacturer becomes aware of in relation to the kind of medical device.
4.4 Requirements of production quality management system
(1) A quality management system that is to be assessed under clause 4.3 must meet the requirements of this clause.
(2) The system must be of a kind such that its application will ensure that:
(a) each medical device to which the system is applied that is of a kind in relation to which the type examination procedures have been applied conforms to the approved type; and
(b) each medical device to which the system is applied that is of a kind to which the declaration of conformity (not requiring assessment by Secretary) procedures are applied is in accordance with the technical documentation prepared under clause 6.4 of those procedures for the device.
(3) The system must include post‑marketing requirements under which the manufacturer of a medical device to which the system is applied is required:
(a) to systematically review experience gained in the post‑production phase in relation to medical devices of that kind; and
(b) to implement appropriate means to apply any necessary corrective action in relation to the design or production of such devices; and
(c) to:
(i) if the manufacturer arranged for assessment of the system under clause 4.3 by the Secretary—notify the Secretary, or the person in relation to whom the kind of device is included in the Register, as soon as practicable after becoming aware of information referred to in subclause (3A); or
(ii) if the manufacturer arranged for assessment of the system under clause 4.3 by an Australian conformity assessment body—notify the body, or the person in relation to whom the kind of device is included in the Register, as soon as practicable after becoming aware of information referred to in subclause (3A).
Note: See also paragraph 41FN(3)(d) and section 41MP of the Act in relation to the requirement to give certain information about a medical device to the Secretary.
(3A) For the purposes of subparagraphs (3)(c)(i) and (ii), the information is the following:
(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 mentioned in subparagraph (a)(i) that has led the manufacturer to take steps to recall devices of that kind that have been distributed.
(4) Each requirement of the system must be documented in a systematic and orderly way in the form of written policies and procedures (for example, as quality programs, quality plans, quality manuals or quality records).
(5) The documentation of the system must include adequate information in relation to the following matters:
(a) the manufacturer’s quality objectives;
(b) the organisation of the manufacturer’s business, including, in particular, a description of the following:
(i) the organisational structure of the business;
(ii) the responsibilities of managerial staff and their authority in relation to the production of the medical devices produced by the manufacturer;
(iii) the methods of monitoring whether the system is operating effectively, in particular, whether the desired quality of product is being achieved and how products that fail to meet the desired quality are controlled;
(c) the inspection and quality assurance techniques applied in the manufacturing process, including, in particular, information about the following:
(i) the processes and procedures to be used (particularly in relation to sterilisation) and the documents relating to those procedures;
(ii) the procedures to be used for purchasing goods or services in relation to the production of the kind of device produced and the documents relating to those procedures;
(iii) product identification procedures to be prepared and kept up‑to‑date from drawings, specifications or other documents at each stage of manufacture;
(d) the tests or trials to be carried out before, during and after production of the kind of medical device to which the system is to be applied, including, in particular, information about:
(i) the frequency with which the tests or trials are to be carried out; and
(ii) the equipment (including the traceability of the calibration of the equipment) used, or to be used, to carry out the tests or trials;
(e) the system for reviewing experience gained in the post‑production phase in relation to the kind of medical device to which the quality management system has been applied, and the means by which any necessary corrective action will be applied in relation to the design or production of such devices;
(f) whether a conformity assessment standard has been applied to the system and, if no conformity assessment standard, or part only of a conformity assessment standard, has been applied to the system—the solutions adopted to ensure that the system complies with subclause (2).
4.5 Changes to production quality management system
(1) This clause applies to the manufacturer of a medical device if:
(a) the manufacturer has implemented, and had assessed under clause 4.3 of this Schedule, a quality management system that is to be applied to the device; and
(b) after assessment, the manufacturer plans to make a substantial change to the system.
(2) The manufacturer must:
(a) notify the Secretary or an Australian conformity assessment body, in writing, of the proposed change; and
(b) arrange for assessment of the change by the Secretary or the Australian conformity assessment body to verify whether the system, as changed, meets the requirements of clause 4.4 of this Schedule.
(3) For the purpose of enabling the assessment to be carried out, the manufacturer must have available, in writing, details of any consequential changes to the information and documentation required under subclause 4.3(2) of this Schedule in relation to the system.
(4) After any change to the quality management system, the manufacturer must ensure that the changed system continues to meet the requirements of clause 4.4 of this Schedule.
4.6 Information to be given to authorised person
(1) If requested to do so by an authorised person, the manufacturer of a medical device must:
(a) give to the Secretary the following information in relation to the quality management system or the kinds of medical device to which the system is applied:
(i) a copy of the documentation mentioned in subclause 4.4(5) of this Schedule;
(ii) data in relation to the production of the kinds of medical device (for example, inspection reports, test data, calibration data, information about the qualifications of staff); and
(b) arrange for tests specified by the authorised person to be carried out for the purpose of checking whether the quality management system is operating effectively.
(2) If any inspections or tests are carried out by an authorised person under this clause, the manufacturer may ask the authorised person to give to the manufacturer a report stating the findings of the inspections or tests.
4.7 Declaration of conformity
(1) The manufacturer of a Class AIMD medical device, Class 4 IVD medical device, Class 3 IVD medical device, Class III medical device or Class IIb medical device to which a quality management system that has been assessed under clause 4.3 of this Schedule has been applied must make a declaration of conformity in relation to the kind of device.
Note: This clause need not be applied to the following kinds of medical devices, if the declaration of conformity (not requiring assessment by Secretary) procedures have been applied to the device:
(a) a Class IIa medical device—see Division 3.2, subparagraph 3.8(1)(b)(ii);
(b) a Class 2 IVD medical device—see Division 3.2, paragraph 3.8A(b);
(c) a Class I medical device that the manufacturer intends to be supplied in a sterile state—see Division 3.2, subclause 3.9(2);
(d) a Class I medical device that has a measuring function—see Division 3.2, paragraph 3.9(3)(b).
(2) The declaration must:
(a) state that the declaration is a declaration of conformity made under clause 4.7 of Schedule 3 to the Therapeutic Goods (Medical Devices) Regulations 2002; and
(b) state the name and business address of the manufacturer of the device; and
(c) state the following information in relation to each kind of medical device to which the system has been applied:
(i) the medical device classification;
(ii) the device nomenclature system code; and
(d) if the system has not been applied to all medical devices of that kind manufactured by the manufacturer—give details of the medical devices to which the system has been applied (for example, by reference to lot numbers, batches or serial numbers, or by specifying the kinds of medical devices or the times of manufacture); and
(e) for a kind of device in relation to which the type examination procedures have been applied—state that:
(i) the type examination procedures have been applied to the kind of device; and
(ii) the kind of device conforms to the approved type; and
(f) state the identification number of the conformity assessment certificate, or of the Australian conformity assessment body certificate, issued in relation to the system or the kind of medical devices to which the system has been applied; and
(g) state that each kind of medical device to which the system has been applied complies with the applicable provisions of the essential principles, the classification rules and the production quality assurance procedures before being supplied; and
(h) give details of any conformity assessment standard that has been applied to the system; and
(i) be signed by a person authorised by the manufacturer; and
(j) set out the name and position of the person signing the declaration; and
(k) state the date when the declaration is signed.
4.8 Records
(1) The manufacturer of a kind of medical device to which a quality management system that has been assessed under clause 4.3 of this Schedule has been applied must keep the following records in relation to the system and the kind of device:
(a) the documentation mentioned in subclause 4.4(5) of this Schedule;
(b) details of any changes made to the system and to the information and documentation required under subclause 4.5(3) of this Schedule;
(c) for a Class AIMD medical device, Class 4 IVD medical device, Class 3 IVD medical device, Class III medical device or Class IIb medical device—the declaration of conformity under clause 4.7 of this Schedule;
(d) any notice, report, certificate or other document in relation to the system issued to the manufacturer by the Secretary or an Australian conformity assessment body.
(2) The manufacturer must keep the records for at least 5 years after the manufacture of the last medical device to which the quality management system was applied.
(3) On request from the Secretary, the manufacturer must make the records available to the Secretary.
Part 5—Product quality assurance procedures
5.1 Overview
The conformity assessment procedures set out in this Part provide for the manufacturer of a kind of medical device:
(a) to:
(i) implement a product quality management system for the final inspection and testing of the kind of device; and
(ii) arrange for assessment of the system by the Secretary or an Australian conformity assessment body; and
(b) to allow the Secretary or an Australian conformity assessment body to monitor the operation of, and carry out inspections of, the system; and
(c) to make a declaration of conformity in relation to the kind of device; and
(d) to:
(i) notify the Secretary or an Australian conformity assessment body of any change to the system, or to the kinds of devices to which the system is to be applied; and
(ii) arrange for assessment of any such change by the Secretary or an Australian conformity assessment body; and
(e) to establish and keep up‑to‑date a post‑market monitoring, reporting and corrective action system.
Note: See Division 3.2 in relation to the kinds of medical devices to which these conformity assessment procedures may be applied.
5.2 References to kinds of medical devices
A reference in this Part to a kind of medical device includes a reference to an individual medical device.
5.3 Implementation and assessment of product quality management system
(1) The manufacturer of a medical device must:
(a) implement a product quality management system for the final inspection and testing of the kind of device; and
(b) arrange for assessment of the system by the Secretary or an Australian conformity assessment body.
(2) For the purpose of enabling the assessment to be carried out, the manufacturer must have available, in writing, the following information and undertakings:
(a) the name and business address of the manufacturer;
(b) details of each manufacturing site where the system is to be applied;
(c) all relevant information about the kinds of medical devices to which the system is to be applied;
(d) the documentation in relation to the system;
(e) an undertaking by the manufacturer to continue to comply with the requirements of the system after assessment;
(f) an undertaking by the manufacturer to ensure that the system is at all times adequate and efficacious;
(g) for a kind of device in relation to which the type examination procedures have been applied—evidence that the device conforms to the approved type and the technical documentation required under subclause 2.3(3) of the type examination procedures for the device;
(h) for a kind of device to which the declaration of conformity (not requiring assessment by Secretary) procedures have been applied—a copy of the technical documentation prepared under clause 6.4 of those procedures for that kind of device;
(i) an undertaking by the manufacturer:
(i) if the manufacturer arranged for assessment of the system by the Secretary—to notify the Secretary, or the person in relation to whom the kind of device is included in the Register, of any information of the kind mentioned in paragraph 5.4(3A)(a) or (b) that the manufacturer becomes aware of in relation to the kind of medical device; or
(ii) if the manufacturer arranged for assessment of the system by an Australian conformity assessment body—to notify the body, or the person in relation to whom the kind of device is included in the Register, of any information of the kind mentioned in paragraph 5.4(3A)(a) or (b) that the manufacturer becomes aware of in relation to the kind of medical device.
5.4 Requirements of product quality management system
(1) A quality management system that is to be assessed under clause 5.3 must meet the requirements of this clause.
(2) The system must be of a kind such that its application will ensure that each medical device, or representative sample of each batch of medical devices, is examined and tested to ensure that the device, or representative sample:
(a) for a kind of device in relation to which the type examination procedures have been applied—conforms to the approved type; or
(b) for a kind of device to which the declaration of conformity (not requiring assessment by Secretary) procedures have been applied—is in accordance with the technical documentation prepared under clause 6.4 of those procedures for the device.
(3) The system must include post‑marketing requirements under which the manufacturer of a medical device to which the system is applied is required:
(a) to systematically review experience gained in the post‑production phase in relation to medical devices of that kind; and
(b) to implement appropriate means to apply any necessary corrective action in relation to the design or production of such devices; and
(c) to:
(i) if the manufacturer arranged for assessment of the system under clause 5.3 by the Secretary—notify the Secretary, or the person in relation to whom the kind of device is included in the Register, as soon as practicable after becoming aware of information referred to in subclause (3A); or
(ii) if the manufacturer arranged for assessment of the system under clause 5.3 by an Australian conformity assessment body—notify the body, or the person in relation to whom the kind of device is included in the Register, as soon as practicable after becoming aware of information referred to in subclause (3A).
Note: See also paragraph 41FN(3)(d) and section 41MP of the Act in relation to the requirement to give certain information about a medical device to the Secretary.
(3A) For the purposes of subparagraphs (3)(c)(i) and (ii), the information is the following:
(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 mentioned in subparagraph (a)(i) that has led the manufacturer to take steps to recall devices of that kind that have been distributed.
(4) Each requirement of the system must be documented in a systematic and orderly way in the form of written policies and procedures (for example, as quality programs, quality plans, quality manuals or quality records).
(5) The documentation of the system must include adequate information in relation to the following matters:
(a) the manufacturer’s quality objectives;
(b) the organisation of the manufacturer’s business, including, in particular, a description of the following:
(i) the organisational structure of the business;
(ii) the responsibilities of managerial staff and their authority in relation to the quality of the medical devices manufactured by the manufacturer;
(iii) the methods of monitoring whether the system is operating effectively, in particular, whether the desired quality of product is being achieved and how products that fail to meet the desired quality are controlled;
(c) the examinations and tests to be carried out after manufacture, including, in particular, information about:
(i) the frequency with which the examinations and tests are to be carried out; and
(ii) the equipment (including the traceability of the calibration of the equipment) to be used to carry out the examinations and tests;
(d) the quality records to be kept, including, for example, records in relation to inspections, tests, calibration of equipment and qualifications of staff.
5.5 Changes to product quality management system or kinds of medical device
(1) This clause applies to the manufacturer of a medical device if:
(a) the manufacturer has implemented, and had assessed under clause 5.3 of this Schedule, a quality management system that is to be applied to the device; and
(b) after assessment, the manufacturer plans to make:
(i) a substantial change to the system; or
(ii) a change to the kinds of medical devices to which the system is to be applied.
(2) The manufacturer must:
(a) notify the Secretary or an Australian conformity assessment body, in writing, of the proposed change; and
(b) arrange for assessment of the change by the Secretary or the Australian conformity assessment body to verify whether the system, as changed, meets the requirements of clause 5.4 of this Schedule.
(3) For the purpose of enabling the assessment to be carried out, the manufacturer must have available, in writing, details of any consequential changes to the information and documentation required under subclause 5.3(2) of this Schedule in relation to the system or kinds of devices.
(4) After any change to the quality management system, the manufacturer must ensure that the changed system continues to meet the requirements of clause 5.4 of this Schedule.
5.6 Information to be given to authorised person
(1) If requested to do so by an authorised person, the manufacturer of a medical device must:
(a) give to the Secretary any of the following information in relation to the quality management system or the kinds of medical device to which the system is applied:
(i) a copy of the documentation mentioned in subclause 5.4(5) of this Schedule;
(ii) the quality records in relation to the final inspection and testing of the kinds of medical device to which the system is applied (for example, inspection reports, test data, calibration data, information about the qualifications of staff); and
(b) arrange for tests specified by the authorised person to be carried out for the purpose of checking whether the quality management system is operating effectively.
(2) If any inspections or tests are carried out by an authorised person in relation to the manufacturer’s premises, or medical devices manufactured by the manufacturer, the manufacturer may ask the authorised person to give to the manufacturer a report stating the findings of the inspections or tests.
5.7 Declaration of conformity
(1) The manufacturer of a Class IIb medical device to which a quality management system that has been assessed under clause 5.3 of this Schedule has been applied must make a declaration of conformity in relation to the kind of device.
Note: This clause need not be applied to the following kinds of medical devices if the declaration of conformity (not requiring assessment by Secretary) procedures have been applied to the device:
(a) a Class IIa medical device (see Division 3.2, subparagraph 3.8(1)(b)(iii));
(b) a Class I medical device that has a measuring function (see Division 3.2, paragraph 3.9(3)(c)).
(2) The declaration must:
(a) state that the declaration is a declaration of conformity made under clause 5.7 of Schedule 3 to the Therapeutic Goods (Medical Devices) Regulations 2002; and
(b) state the name and business address of the manufacturer of the device; and
(c) state the following information in relation to each kind of medical device to which the system has been applied:
(i) the unique product identifier (for example, the product name or model number);
(ii) the medical device classification;
(iii) the device nomenclature system code; and
(d) if the system has not been applied to all medical devices of that kind manufactured by the manufacturer—give details of the medical devices to which the system has been applied (for example, by reference to lot numbers, batches or serial numbers, or by specifying the kinds of medical devices or the times of manufacture); and
(e) for a kind of device in relation to which the type examination procedures have been applied—state that:
(i) the type examination procedures have been applied to the kind of device; and
(ii) the kind of device conforms to the approved type; and
(f) for a kind of device to which the declaration of conformity (not requiring assessment by Secretary) procedures have been applied—state that the kind of device is in accordance with the technical documentation prepared under clause 6.4 of those procedures for the kind of device; and
(g) state the identification number of the conformity assessment certificate, or of the Australian conformity assessment body certificate, issued in relation to the system or the kind of medical devices to which the system has been applied; and
(h) give details of any conformity assessment standard that has been applied to the system; and
(i) be signed by a person authorised by the manufacturer; and
(j) set out the name and position of the person signing the declaration; and
(k) state the date when the declaration is signed.
5.8 Records
(1) The manufacturer of a kind of medical device to which a quality management system that has been assessed under clause 5.3 of this Schedule has been applied must keep the following records in relation to the system and the kind of device:
(a) the documentation mentioned in subclause 5.4(5) of this Schedule;
(b) details of any changes made to the system and to the information and documentation required under subclause 5.5(3) of this Schedule;
(c) details of any changes made to the kinds of medical devices to which the system was applied;
(d) for a Class IIb medical device—the declaration of conformity under clause 5.7 of this Schedule;
(e) any notice, report, certificate or other document in relation to the system issued to the manufacturer by the Secretary or an Australian conformity assessment body.
(2) The manufacturer must keep the records for at least 5 years after the manufacture of the last medical device to which the quality management system was applied.
(3) On request from the Secretary, the manufacturer must make the records available to the Secretary.
Part 6—Declaration of conformity (not requiring assessment by Secretary) procedures
6.1 Overview
The conformity assessment procedures set out in this Part provide for the manufacturer of a kind of medical device:
(a) to prepare technical documentation in relation to the kind of device to enable assessment of the device; and
(b) to make a declaration of conformity in relation to the kind of device; and
(c) to establish and keep up‑to‑date a post‑market monitoring, reporting and corrective action system.
Note: See Division 3.2 in relation to the kinds of medical devices to which these conformity assessment procedures may be applied.
6.2 References to kinds of medical devices
A reference in this Part to a kind of medical device includes a reference to an individual medical device.
6.3 Implementation
(1) The manufacturer of a medical device must prepare technical documentation in relation to the kind of device in a form that, if the Secretary decides to do so, would allow the Secretary to assess whether the device complies with the applicable provisions of the essential principles, the classification rules and these conformity assessment procedures.
(2) For the purpose of enabling an assessment to be carried out, the manufacturer must have available, in writing, the following information and undertakings:
(a) the name and business address of the manufacturer;
(b) details of each manufacturing site where these conformity assessment procedures are to be applied;
(c) all relevant information required to identify the kinds of medical devices to which these conformity assessment procedures are to be applied;
(d) an undertaking by the manufacturer to notify the Secretary, or the person in relation to whom the kind of device is included in the Register, of any information of the kind mentioned in subparagraph 6.5(2)(c)(i) or (ii) that the manufacturer becomes aware of in relation to a kind of medical device.
6.4 Required technical documentation
(1) The technical documentation must include adequate information in relation to the kind of device, and must include, in particular, the following:
(a) a general description of the kind of device, and of any variants of the kind of device that the manufacturer plans to manufacture;
(b) diagrams or drawings of the design of the kind of device, including diagrams or drawings of any components, sub‑assemblies or circuits of the kind of device;
(c) any descriptions or explanations that are necessary to enable the diagrams or drawings mentioned in paragraph (b), or the intended operation of the kind of device, to be properly understood;
(d) if the kind of device is intended by the manufacturer to be supplied in a sterile state—a description of the method used to sterilise the kind of device;
(e) details of each medical device standard or conformity assessment standard that has been applied, wholly or in part, to the kind of device;
(f) if no medical device standard or conformity assessment standard has been applied, or a medical device standard or conformity assessment standard has been only partly applied, to the kind of device—the solutions adopted to ensure that each device complies with the applicable provisions of the essential principles;
(g) the results of any design calculations, risk analyses, investigations, technical tests, or any other tests, carried out in relation to the kind of device;
(h) if the kind of device is intended by the manufacturer to be connected to another device—evidence demonstrating that the device will comply with the applicable provisions of the essential principles when it is connected to the other device and both devices are being used for their intended purposes;
(i) a copy of the clinical evidence, in relation to the kind of device, required by the clinical evaluation procedures;
(j) a copy of the information to be provided with the kind of device.
(2) If the manufacturer makes a change to the design or the production of the kind of medical device after the technical documentation has been prepared (for example, because it was necessary to apply corrective action in relation to the kind of device), the manufacturer must revise the technical documentation to take account of the change.
6.5 Post‑marketing system
(1) The manufacturer of a medical device to which technical documentation prepared under clause 6.4 of this Schedule applies must establish, and keep up‑to‑date, a post‑marketing system that complies with subclause (2) for use in relation to devices of that kind.
(2) A post‑marketing system complies with this subclause in relation to a medical device if the system requires the manufacturer of the device:
(a) to systematically review experience gained in the post‑production phase in relation to medical devices of that kind; and
(b) to implement appropriate means to apply any necessary corrective action in relation to the design or production of such devices; and
(c) to notify the Secretary, or the person in relation to whom the kind of device is included in the Register, as soon as practicable after becoming aware of:
(i) information relating to:
(A) any malfunction or deterioration in the characteristics or performance of the kind of device; or
(B) any inadequacy in the design, production, labelling, instructions for use or advertising materials of the kind of device; or
(C) 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; or
(ii) information relating to any technical or medical reason for a malfunction or deterioration of a kind mentioned in subparagraph (i) that has led the manufacturer to take steps to recall devices of that kind that have been distributed.
Note: See also paragraph 41FN(3)(d) and section 41MP of the Act in relation to the requirement to give certain information about a medical device to the Secretary.
6.6 Declaration of conformity
(1) The manufacturer of a kind of medical device to which technical documentation prepared under clause 6.4 of this Schedule applies must make a declaration of conformity in relation to the kind of device.
(2) The declaration must:
(a) state that the declaration is a declaration of conformity made under clause 6.6 of Schedule 3 to the Therapeutic Goods (Medical Devices) Regulations 2002; and
(b) state the name and business address of the manufacturer of the device; and
(c) state the following information in relation to each kind of medical device to which the technical documentation applies:
(i) the unique product identifier (for example, the product name or model number);
(ii) the medical device classification;
(iii) the device nomenclature system code; and
(d) if the technical documentation applies to a Class IIa medical device that the manufacturer intends to be supplied in a sterile state or a Class I medical device that the manufacturer intends to be supplied in a sterile state—state that the production quality assurance procedures have also been applied to the device; and
(e) if the technical documentation applies to a Class IIa medical device that the manufacturer intends to be supplied in a non‑sterile state, or a Class I medical device that has a measuring function and that the manufacturer intends to be supplied in a non‑sterile state—state which of the following conformity assessment procedures have also been applied to the device:
(i) the verification procedures;
(ii) the production quality assurance procedures;
(iii) the product quality management system procedures; and
(f) if the technical documentation does not apply to all medical devices of that kind manufactured by the manufacturer—give details of the medical devices to which the technical documentation applies (for example, by reference to lot numbers, batches or serial numbers, or by specifying the kinds of medical devices or the times of manufacture); and
(g) state that each kind of medical device to which the technical documentation applies complies with the applicable provisions of the essential principles, the classification rules, and these procedures; and
(h) if the technical documentation applies to any of the following kinds of medical devices:
(i) a Class IIa medical device;
(ii) a Class 2 IVD medical device;
(iii) a Class I medical device that the manufacturer intends to be supplied in a sterile state;
(iv) a Class I medical device that has a measuring function;
state the identification number of the conformity assessment certificate, or of the Australian conformity assessment body certificate, issued in relation to the kind of medical device, or the quality management system that has been applied to the kind of device, as a result of the application to the device of the conformity assessment procedures set out in Part 3, 4 or 5 of this Schedule; and
(i) give details of any medical device standard or conformity assessment standard that has been applied to the device; and
(j) be signed by a person authorised by the manufacturer; and
(k) set out the name and position of the person signing the declaration; and
(l) state the date when the declaration is signed.
6.7 Records
(1) The manufacturer of a medical device to which technical documentation prepared under clause 6.4 of this Schedule applies must keep the following records:
(a) the technical documentation prepared under clause 6.4 of this Schedule, including any revisions of the documentation prepared as a result of changes to the design or production of the kind of device;
(b) details of any changes made to the design or production of the kind of medical device and to the documentation required under clause 6.4 of this Schedule;
(c) the declaration of conformity under clause 6.6 of this Schedule.
(2) The manufacturer must keep the records for at least 5 years after the manufacture of the last medical device to which the technical documentation prepared clause 6.4 of this Schedule applies.
(3) On request from the Secretary, the manufacturer must make the records available to the Secretary.
Part 6A—Procedures applying to Class 1, 2 and 3 in‑house IVD medical devices
6A.1 Overview
The conformity assessment procedures set out in this Part provide for the manufacturer of a Class 1 in‑house IVD medical device, Class 2 in‑house IVD medical device or Class 3 in‑house IVD medical device to do the following:
(a) implement procedures relating to the application of a quality management system to the manufacture of the device;
(b) provide information to the Secretary about the quality management system and the device;
(c) establish and keep up‑to‑date a post‑market monitoring, reporting and corrective action system.
6A.2 Procedures
Notification of devices being manufactured
(1) The manufacturer of a Class 1 in‑house IVD medical device, Class 2 in‑house IVD medical device or Class 3 in‑house IVD medical device must notify the Secretary, in accordance with subclauses (2) and (3), of all the Class 1, 2 or 3 in‑house IVD medical devices being manufactured.
(2) A notification under subclause (1) must:
(a) be in a form approved in writing by the Secretary; and
(b) contain the information required by the form; and
(c) cover each Class 1, 2 or 3 in‑house IVD medical device being manufactured at the time the notification is given.
(3) A notification under subclause (1) must be given to the Secretary:
(a) if the manufacturer manufactures one or more Class 1, 2 or 3 in‑house IVD medical devices before 1 July 2017—no later than 20 working days after 1 July 2017; and
(b) if, in a financial year, the manufacturer starts to manufacture a Class 1, 2 or 3 in‑house IVD medical device not covered by the most recent of any previous notification given to the Secretary under subclause (1)—by the later of the following:
(i) 1 July of the next financial year;
(ii) 20 working days after manufacturing the device for the first time.
Accreditation requirements etc.
(4) The laboratory in which the Class 1, 2 or 3 in‑house IVD medical device is manufactured must:
(a) be accredited as a testing laboratory by NATA, or by a conformity assessment body determined by the Secretary, as meeting one of the following standards, as published by the International Organization for Standardization and as amended from time to time:
(i) ISO 15189, Medical laboratories—Requirements for quality and competence;
(ii) ISO/IEC 17025, General requirement for the competence of testing and calibration laboratories; and
(b) meet the National Pathology Accreditation Advisory Council standard Requirements for the Development and Use of in‑house In Vitro Diagnostic Devices (IVDs), as amended from time to time.
6A.3 Information to be given to the Secretary
(1) On request by an authorised person, the manufacturer of a Class 1, 2 or 3 in‑house IVD medical device must:
(a) give to the Secretary, within the period specified in the request (which must not be less than 20 working days after the request is made), the following information in relation to the device and the quality management system applied to the device:
(i) a copy of the documentation mentioned in subclause (2);
(ii) data for the design of the device (for example, the results of any analysis of the device, calculations or tests);
(iii) data for the manufacture of the device (for example, inspection reports, test data, calibration data, information about the qualifications of staff); and
(b) arrange for tests specified by the authorised person to be carried out for the purpose of checking whether the quality management system is operating effectively.
(2) The documentation must include the following information:
(a) the manufacturer’s quality objectives;
(b) the organisation of the manufacturer’s business, including a description of the following:
(i) the organisational structure of the business;
(ii) the responsibilities of managerial staff and their authority in relation to the quality of the design and production of medical devices manufactured by the manufacturer;
(iii) the methods of monitoring whether the system is operating effectively, including whether the desired quality of design and product is being achieved and how products that fail to meet the desired quality are controlled;
(c) the design of the medical device to which the system is to be applied, including the following:
(i) details of the processes, systems and measures used for controlling, monitoring and verifying that, at each stage of the design process, the device complies with the applicable provisions of the essential principles;
(ii) a general description of the device;
(iii) details of the design specifications for the device, including:
(A) any medical device standard that has been applied to the device; and
(B) the results of the risk analysis carried out; and
(C) if no medical device standard, or part of it, has been applied to the device—the solutions adopted to ensure that each device complies with the applicable provisions of the essential principles;
(iv) for a device that is intended by the manufacturer to be connected to another device—evidence demonstrating that the device will comply with the applicable provisions of the essential principles when it is connected to the other device and both devices are being used for their intended purposes;
(v) a statement indicating whether or not the device contains viable tissues, cells or substances of human or animal origin;
(vi) a copy of the clinical evidence, in relation to the device, required by the clinical evaluation procedures;
(vii) a copy of the information to be provided with the device, when relevant;
(d) the inspection and quality assurance techniques to be applied in the production of the medical device to which the system is to be applied, including information about the following:
(i) the processes and procedures to be used and the documents relating to those processes and procedures;
(ii) the procedures to be used for purchasing goods or services in relation to the production of the device and the documents relating to those procedures;
(iii) product identification procedures to be prepared and kept up‑to‑date from drawings, specifications or other documents at each stage of production;
(e) the tests or trials to be carried out before, during and after production of the medical device to which the system is to be applied, including information about:
(i) the frequency with which the tests or trials are to be carried out; and
(ii) the equipment (including the traceability of the calibration of the equipment) used, or to be used, to carry out the tests or trials;
(f) the system for reviewing experience gained in the post‑production phase for the medical device to which the quality management system has been applied, and the means by which any necessary corrective action will be applied to the design or production of such devices.
(3) If any inspections or tests are carried out by an authorised person in relation to the manufacturer’s premises, or medical devices produced by the manufacturer, the manufacturer may ask the authorised person to give to the manufacturer a report stating the findings of the inspections or tests.
6A.4 Post‑marketing system
(1) The manufacturer of a Class 1, 2 or 3 in‑house IVD medical device must establish, and keep up‑to‑date, a post‑marketing system for use for the device.
(2) The post‑marketing system must require the manufacturer of the device to:
(a) systematically review experience gained in the post‑production phase for the device; and
(b) implement appropriate means to apply any necessary corrective action for the design or production of the device; and
(c) notify the Secretary as soon as practicable after becoming aware of information relating to any of the following 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:
(i) any malfunction or deterioration in the characteristics or performance of the device;
(ii) any inadequacy in the design, production, labelling, instructions for use or advertising materials of the device;
(iii) any use in accordance with, or contrary to, the use intended by the manufacturer of the device.
Part 6B—Procedures applying to Class 4 in‑house IVD medical devices
6B.1 Overview
The conformity assessment procedures set out in this Part provide for the manufacturer of a Class 4 in‑house IVD medical device to do the following:
(a) implement a quality management system for the design, production, packaging, labelling and final inspection of that kind of device;
(b) prepare technical documentation in relation to that kind of device;
(c) establish and keep up‑to‑date a post‑market monitoring, reporting and corrective action system;
(d) make a declaration of conformity in relation to that kind of device;
(e) prepare and keep records in relation to these procedures.
6B.2 References to kinds of medical devices
A reference in this Part to a kind of medical device includes a reference to an individual medical device.
6B.3 Procedures
(1) The manufacturer of a Class 4 in‑house IVD medical device must implement a quality management system for the design, production, packaging, labelling and final inspection of that kind of device.
(2) If the kind of device is used in relation to the manufacture of blood, blood components and plasma derivatives, human cell and tissue based therapeutic goods, either:
(a) the manufacturer must:
(i) satisfy the requirements in the Australian Code of Good Manufacturing Practice for Blood and Blood Components, Human Tissues and Human Cellular Therapy Products, published by the Therapeutic Goods Administration, as amended from time to time; and
(ii) hold a manufacturing licence that is in force and authorises the carrying out of a step in the manufacture of blood, blood components and plasma derivatives, human cell and tissue based therapeutic goods; or
(b) the laboratory in which the kind of device is manufactured must:
(i) be accredited as a testing laboratory by NATA as meeting ISO 15189, Medical laboratories—Requirements for quality and competence, published by the International Organization for Standardization, as amended from time to time; and
(ii) meet the National Pathology Accreditation Advisory Council standard Requirements for the Development and Use of in‑house In Vitro Diagnostic Devices (IVDs), as amended from time to time.
(3) If the kind of device is not used in relation to the manufacture of blood, blood components and plasma derivatives, human cell and tissue based therapeutic goods, the laboratory in which the kind of device is manufactured must:
(a) be accredited as a testing laboratory by NATA as meeting ISO 15189, Medical laboratories—Requirements for quality and competence, published by the International Organization for Standardization, as amended from time to time; and
(b) meet the National Pathology Accreditation Advisory Council standard Requirements for the Development and Use of in‑house In Vitro Diagnostic Devices (IVDs), as amended from time to time.
6B.4 Required technical documentation
(1) The manufacturer of a Class 4 in‑house IVD medical device must ha