Therapeutic Goods (Medical Devices) Regulations 2002

In force

Administered by

Department of Health and Aged Care

This item is authorised by the following title:

Therapeutic Goods Act 1989

Superseded version

View latest version

F2024C00537 (C62)

15 June 2024 - 30 June 2024

This instrument was backcaptured in accordance with Section 36 of the Legislative Instruments Act 2003

Table of contents

Part 1—Preliminary
- 1.1 Name of Regulations
- 1.3 Definitions—the dictionary etc
- 1.4 Medical devices with a measuring function
- 1.5 Refurbishment (Act s 3(1))
- 1.6 Kinds of medical devices—other common characteristics (Act s 41BE(1)(e))
- 1.7 Device nomenclature system codes (Act s 41BE(3))
- 1.8 Classes of persons that are not manufacturers of a medical device
Part 2—Essential principles
- 2.1 Essential principles (Act s 41CA)
Part 3—Conformity assessment procedures
- Division 3.1—Medical device classifications
  - 3.1 Medical device classifications (Act s 41DB)
  - 3.2 Classification of medical devices
  - 3.3 Principles for applying the classification rules
- Division 3.2—Conformity assessment procedures
- 3.4 Conformity assessment procedures (Act s 41DA)
- 3.5 Powers and functions of Secretary in relation to conformity assessment
- 3.6 Class III medical devices (other than medical devices used for a special purpose)
- 3.6A Class 4 IVD medical devices (other than medical devices to be used for a special purpose)
- 3.6B Class 4 in house IVD medical devices (other than medical devices to be used for a special purpose)
- 3.7 Class IIb medical devices (other than medical devices used for a special purpose)
- 3.7A Class 3 IVD medical devices (other than devices to be used for a special purpose)
- 3.7B Class 3 in house IVD medical devices
- 3.8 Class IIa medical devices (other than medical devices used for a special purpose)
- 3.8A Class 2 IVD medical devices (other than devices to be used for a special purpose)
- 3.8B Class 2 in house IVD medical devices
- 3.9 Class I medical devices (other than medical devices used for a special purpose)
- 3.9A Class 1 IVD medical devices (other than devices to be used for a special purpose)
- 3.9B Class 1 in house IVD medical devices
- 3.10 Medical devices used for a special purpose
- 3.11 Medical devices to which the clinical evaluation procedures must be applied
- 3.12 Records to be provided in English
- 3.13 Assessment or verification at intermediate stage of manufacture
Part 4—Conformity assessment certificates
- Division 4.1—Issuing conformity assessment certificates
  - 4.2 Considering applications for conformity assessment certificates (Act s 41EC)
  - 4.3 Time for making decision on applications (Act s 41ED, s 63(2)(dc))
- Division 4.1A—Conformity assessment (priority applicant) determinations
- Division 4.1B—Content of conformity assessment certificates
  - 4.3F Content of conformity assessment certificates
- Division 4.1C—Conditions
  - 4.3G Conditions applying automatically—information about poisons
- Division 4.2—Suspension of conformity assessment certificates
  - 4.4 Period for revocation of suspension (Act s 41EP, s 63(2)(db))
- Division 4.3—Transfer of conformity assessment certificates
Part 4A—Australian conformity assessment bodies
- Division 4A.1—Preliminary
  - 4A.1 Purposes of this Part
- Division 4A.2—Making conformity assessment body determinations
- Division 4A.3—Conditions on conformity assessment body determinations
- Division 4A.4—Suspension of conformity assessment body determinations
- 4A.20 Suspension of determinations
- 4A.21 Notice of proposed suspension
- 4A.22 Duration of suspension
- 4A.23 Revocation of suspension
- 4A.24 Powers of revocation of determinations unaffected
- Division 4A.5—Revocation of conformity assessment body determinations
- 4A.25 Automatic revocation of determinations
- 4A.26 Immediate revocation of determinations
- 4A.27 Revocation of determinations after notice of proposed revocation
- Division 4A.6—Variation of conformity assessment body determinations
- 4A.28 Imposing, varying or removing conditions
- 4A.29 Limiting determinations
- 4A.30 Notice of proposed variation
- Division 4A.7—Australian conformity assessment body certificates
- 4A.31 Content of Australian conformity assessment body certificates
Part 5—Including medical devices in the Register
- Division 5.1—Including medical devices in the Register
- Division 5.2—Conditions
Part 6—Suspension and cancellation from the Register
- 6.1 Period for revocation of suspension (Act s 41GD, s 63(2)(dd))
Part 6A—Disposal of unused emergency medical devices
- 6A.1 Disposal of unused emergency medical devices
Part 7—Exempting medical devices from inclusion in the Register
- Division 7.1—Exempt devices
  - 7.1 Exempt devices—general (Act s 41HA)
  - 7.2 Exempt devices—use in life threatening cases (Act s 41HA)
- Division 7.2—Exemptions for experimental uses
- Division 7.3—Exemptions for medical practitioners
Part 8—Obtaining information
- 8.1A Matters for which information and documents can be requested
- 8.1 Notice period (Act s 41JA)
Part 8A—Waiver and refund of charges
- 8A.1 Definitions
- 8A.2 Waiver of charges in relation to transitional medical devices
- 8A.3 Refund of certain charges in relation to transitional medical devices
Part 9—Fees
- Division 9.1—Fees
  - 9.1 Fees
- Division 9.1A—Reduced fee for consent to import, supply or export implantable medical devices—information requirements
  - 9.1AA Working out the reduced fee
- Division 9.2—Conformity assessment body determination assessment fees
- Division 9.3—Assessment fees and reductions or refunds of fees connected with applications for conformity assessment certificates
- Division 9.4—Other refunds or waivers of fees
  - 9.9 Other refunds or waivers of fees
Part 10—Miscellaneous
- 10.1 Authorised persons
- 10.2 Information about sponsor
- 10.3 Custom made medical devices—information about manufacturer
- 10.3A Custom made medical devices—information about supplies
- 10.4 Offences—period for notifying adverse events (Act s 41MP)
- 10.4AA Civil penalty—period for notifying adverse events
- 10.4A Secretary may maintain a system to enhance safe and effective use of particular medical devices
- 10.5 Delegation—powers and functions under these Regulations
- 10.6 Delegation—powers under paragraph 41HB(1)(d) of the Act
- 10.6A Delegation of Secretary’s powers under section 41HD of the Act
- 10.6B Forms or manners—software requirements
- 10.7 Review of decisions
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
    - 11.2 Application of 2010 Amendment Regulations
  - Subdivision B—General provisions relating to transitional devices
  - Subdivision C—Listed or registered transitional devices and exempt transitional devices
  - Subdivision D—Approved transitional devices
  - Subdivision E—Class 4 in house IVD medical devices
  - Subdivision F—Class 1, 2 and 3 in house IVD medical devices
    - 11.20 Application of this Subdivision
    - 11.21 Application of 2010 Amendment Regulations for all purposes
- Division 11.2—Transitional provisions relating to joint replacements
  - 11.22A Purpose of this Division
  - 11.22 Certain Class IIb medical devices
  - 11.23 Refund of fees in relation to inclusion of certain devices in the Register as Class III medical devices
- Division 11.3—Transitional provisions relating to the Therapeutic Goods (Medical Devices) Amendment (In Vitro Diagnostic Medical Devices) Regulation 2015
  - 11.24 Definitions
  - 11.25 Application of 2015 Amendment Regulations—transitional Class 4 in house IVD medical devices
  - 11.26 Application of 2015 Amendment Regulations etc.—transitional Class 1, 2 and 3 in house IVD medical devices
- Division 11.4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016
  - 11.27 Application
- Division 11.5—Transitional provisions relating to the Therapeutic Goods (Medical Devices) Amendment (Implantable Medical Devices) Regulations 2017
  - 11.28 Definitions
  - 11.29 Surgical mesh—application of amendments
  - 11.31 Patient information—application of amendments
- Division 11.6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017
  - 11.32 Definitions
  - 11.33 Application—statements in relation to exempt devices
- Division 11.7—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018
  - 11.34 Application of amendments
- 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)
  - 11.36 Application—regulation 5.13 (conditions applying automatically to medical devices included in the Register)
- 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
- Division 11.10—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019
  - Subdivision A—Definitions
    - 11.38 Definitions
  - Subdivision B—Reclassification of medical devices
  - Subdivision C—Programmed or programmable medical device or software that is a medical device
  - Subdivision D—Personalised medical devices
  - Subdivision E—IVD companion diagnostics
    - 11.54 IVD companion diagnostics
- Division 11.11—Application provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020
  - 11.55 System or procedure packs
  - 11.56 Period for notifying adverse events
  - 11.57 Class 4 in house IVD medical devices
- Division 11.12—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 2) Regulations 2021
  - 11.58 Application provisions
- Division 11.13—Application, saving and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021
  - 11.59 System or procedure packs
  - 11.60 Reports about adverse events or occurrences for medical devices
  - 11.61 Patient implant cards and patient information leaflets
  - 11.62 Medical devices assembled or adapted at point of care
  - 11.63 Patient matched medical devices
  - 11.64 Surgical loan kits
  - 11.66 Surgical mesh
- Division 11.14—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021
  - 11.67 Patient implant cards and patient information leaflets
- Division 11.15—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 2) Regulations 2022
  - 11.68 Fee for application for consent of Secretary
- Division 11.16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022
  - 11.69 Fee for application for consent of Secretary
  - 11.70 Exempt medical devices
- Division 11.17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023
  - 11.71 Clinical trials
- Division 11.18—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023
  - 11.72 Clinical trials
- Division 11.19—Application provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023
  - 11.73 Application of amendments
- Division 11.20—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024
  - 11.74 Definitions
  - 11.75 Exemption for certain prescription spectacle lenses
Schedule 1—Essential principles
- Part 1—General principles
- Part 2—Principles about design and construction
Schedule 2—Classification rules for medical devices other than IVD medical devices
- Part 1—Interpretation
  - 1.1 Transient, short term and long term use
- Part 2—Rules for non invasive medical devices
- Part 3—Rules for invasive medical devices and implantable medical devices
- Part 4—Special rules for active medical devices
- Part 5—Special rules for particular kinds of medical devices
Schedule 2A—Classification rules for IVD medical devices
- 1.1 Detection of transmissible agents posing high public health risk
- 1.2 Detection of red blood cell antigens and antibodies and non red cell typing
- 1.3 Detection of transmissible agents or biological characteristics posing moderate public health risk or high personal risk
- 1.4 IVD medical devices for self testing
- 1.5 Non assay specific quality control material
- 1.6 Reagents, instruments etc
- 1.7 Other IVD medical devices are Class 2 IVD medical devices
- 1.8 IVD medical devices intended for export only
Schedule 3—Conformity assessment procedures
- Part 1—Full quality assurance procedures
- Part 2—Type examination procedures
- Part 3—Verification procedures
- Part 4—Production quality assurance procedures
- Part 5—Product quality assurance procedures
- Part 6—Declaration of conformity (not requiring assessment by Secretary) procedures
- Part 6A—Procedures applying to Class 1, 2 and 3 in house IVD medical devices
- Part 6B—Procedures applying to Class 4 in house IVD medical devices
- Part 7—Procedures for medical devices used for a special purpose
- Part 8—Clinical evaluation procedures
Schedule 3AA—Requirements for Australian conformity assessment bodies
- 1 Purpose of this Schedule
- 2 EU Regulations
- 3 Modifications of EU Regulations—general
- 4 Additional requirements
- 5 Additional modifications of EU medical devices regulations
- 6 Modifications of EU IVD regulations
- 7 Expressions used in modifications
Schedule 3A—Disposal of unused emergency medical devices
- 1 Early end of exemption—notice of medical devices held
- 2 End of exemption period—notice of medical devices held
- 3 Storage and disposal of unused emergency medical devices
- 4 Direction for disposal of unused emergency medical devices
- 5 Relocation of unused emergency medical devices
- 6 Disposal of unused emergency medical devices—destruction
- 7 Disposal of unused emergency medical devices—export
- 8 Disposal of unused emergency medical devices—supply
- 9 Owner to be paid for medical devices supplied
- 10 Records about unused emergency medical devices
- 11 Failure to comply with this Schedule
Schedule 4—Exempt devices
- Part 1—Exempt devices—general
- Part 2—Exempt devices—exemption subject to conditions
Schedule 5—Fees
- Part 1—General
- Part 2—Additional fees
  - 2.1 Supplementary assessment
  - 2.2 Costs of testing
Dictionary
- Endnotes

Federal Register of Legislation

Scheduled Maintenance Saturday 3 May

Therapeutic Goods (Medical Devices) Regulations 2002

Scheduled Maintenance Saturday 3 May

Therapeutic Goods (Medical Devices) Regulations 2002

Legislation text