Therapeutic Goods (Medical Devices) Regulations 2002

In force

Administered by

Department of Health, Disability and Ageing

This item is authorised by the following title:

Therapeutic Goods Act 1989

Superseded version

View latest version

View as made version

F2017C00534 C32

01 July 2017 - 01 December 2017

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))
Part 2—Essential principles
- 2.1 Essential principles (Act s 41CA)
Part 3—Conformity assessment procedures
- Division 3.1—Medical device classifications
- Division 3.2—Conformity assessment procedures
Part 4—Conformity assessment certificates
- Division 4.1—Issuing conformity assessment certificates
- 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 5—Including medical devices in the Register
- Division 5.1—Including medical devices in the Register
  - 5.2 Matters to be certified—period for obtaining information from manufacturer (Act s 41FD)
  - 5.3 Selecting applications for auditing (Act s 41FH)
- 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)
- 8.2 Exempt devices—statement by medical practitioner (Act s 41JD)
Part 9—Fees
- 9.1 Fees
- 9.2 Application audit assessment fee (Act ss 41LA, 41LB)
- 9.3 Conformity assessment fee (Act ss 41LA, 41LB)
- 9.4 Conformity assessment fee—abridged assessment
- 9.5 Payment of assessment fee by instalments (Act s 41LC)
- 9.6 Reduction of assessment fees
- 9.7 Reduction of assessment fees—abridged assessment
Part 10—Miscellaneous
- 10.1 Authorised persons
- 10.2 Information about sponsor
- 10.3 Custom-made medical devices—information about manufacturer
- 10.4 Offences—period for notifying adverse events (Act s 41MP)
- 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
- 10.7 Review of decisions
Part 11—Transitional provisions
- Division 11.1—Transitional provisions relating to the Therapeutic Goods (Medical Devices) Amendment Regulations 2010 (No. 1)
- Division 11.2—Transitional provisions relating to joint replacements
- Division 11.3—Transitional provisions relating to the Therapeutic Goods (Medical Devices) Amendment (In Vitro Diagnostic Medical Devices) Regulation 2015
- Division 11.4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016
  - 11.27 Application
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 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 - Tuesday 30 December 2025 from 8pm AEST

Therapeutic Goods (Medical Devices) Regulations 2002

Scheduled Maintenance - Tuesday 30 December 2025 from 8pm AEST

Therapeutic Goods (Medical Devices) Regulations 2002

Legislation text