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Superseded version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

F2017C01165 (C33)

02 December 2017 - 31 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
  - 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 and Class AIMD 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
- 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)
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
- 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 11.6—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
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

Therapeutic Goods (Medical Devices) Regulations 2002

Legislation text