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

Latest version

F2025C00386 (C67)

25 March 2025

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 9A—Australian Unique Device Identification Database
- 9A.1 Australian Unique Device Identification Database
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
  - 11.23 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
  - 11.76 Auditing of applications
  - 11.77 Reclassification of medical devices
- Division 11.21—Application provisions relating to the Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2024
  - 11.78 Application provision—application audit assessment fees
- Division 11.22—Application provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024
  - 11.79 Definitions
  - 11.80 Application of amendments
  - 11.81 Transitional vaping devices—exemption from Division 3 of Part 4 11 of the Act
- Division 11.23—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024
  - 11.82 Definitions
  - 11.83 Exempt therapeutic goods
  - 11.84 Notices, statements and determinations
- Division 11.24—Application provisions relating to the Therapeutic Goods Legislation Amendment (Australian Unique Device Identification Database and Other Measures) Regulations 2025
  - 11.85 Application provisions—Australian Unique Device Identification Database
Schedule 1—Essential principles
- Part 1—General principles
- Part 2—Other principles
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

Administrative Arrangements Order - 13 May 2025

Therapeutic Goods (Medical Devices) Regulations 2002

Administrative Arrangements Order - 13 May 2025

Therapeutic Goods (Medical Devices) Regulations 2002

Legislation text