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THERAPEUTIC GOODS (MEDICAL DEVICES) REGULATIONS 2002

- made under the Therapeutic Goods Act 1989

Table of Provisions

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

  • 4.3A Application of Division
  • 4.3B Application for conformity assessment (priority applicant) determination
  • 4.3C Making of conformity assessment (priority applicant) determination
  • 4.3D Period during which conformity assessment (priority applicant) determination is in force
  • 4.3E Revocation of conformity assessment (priority applicant) determination

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

  • 4.5 Application of Division 4.3
  • 4.6 Death, bankruptcy or winding up of manufacturer
  • 4.7 Disposal of business or amalgamation with another manufacturer
  • 4.8 Change of name of manufacturer
  • 4.9 Effect of conformity assessment certificate after transfer, etc
  • 4.10 Notification to Secretary of events
  • 4.11 Notification of change of name or suspension or revocation of conformity assessment certificate

PART 4A--AUSTRALIAN--CONFORMITY ASSESSMENT BODIES

Division 4A.1--Preliminary

  • 4A.1 Purposes of this Part

Division 4A.2--Making conformity assessment body determinations

  • 4A.2 Applications
  • 4A.3 Further information
  • 4A.4 Documents to be provided in English
  • 4A.5 Lapsing of applications
  • 4A.6 Assessing applications
  • 4A.7 Procedure following decisions to make determinations
  • 4A.8 Duration of determinations
  • 4A.9 Procedure following decisions not to make determinations

Division 4A.3--Conditions on conformity assessment body determinations

Subdivision A--Automatic conditions on determinations
  • 4A.10 Automatic conditions on determinations
  • 4A.11 Conditions--requirements of Schedule 3AA
  • 4A.12 Conditions--notifying Secretary and clients
  • 4A.13 Conditions--entry and inspection
  • 4A.14 Conditions--producing information and documents
  • 4A.15 Conditions--reviews
  • 4A.16 Conditions--record keeping
  • 4A.17 Conditions--Australian conformity assessment body certificates
  • 4A.18 Conditions--clients
  • Subdivision B--Conditions specified in conformity assessment body determinations
  • 4A.19 Conditions specified in 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

Subdivision A--Applications
  • 5.2 Matters to be certified--period for obtaining information from manufacturer (Act s 41FD)
  • Subdivision C--Auditing of applications
  • 5.3 Selecting applications for auditing (Act s 41FH)
  • Subdivision D--Miscellaneous--medical devices (priority applicant) determinations
  • 5.4 Application of Subdivision
  • 5.4A Application for medical devices (priority applicant) determination
  • 5.4B Making of medical devices (priority applicant) determination
  • 5.4C Period during which medical devices (priority applicant) determination is in force
  • 5.4D Revocation of medical devices (priority applicant) determination

Division 5.2--Conditions

  • 5.7 Conditions applying automatically--period for giving information about adverse events etc (Act s 41FN)
  • 5.8 Conditions applying automatically--requirements in relation to information about kind of medical device (Act s 41FN)
  • 5.8A Conditions applying automatically--giving of report about adverse events or occurrences (Act s 41FN)
  • 5.9 Conditions applying automatically--storage and transport of medical devices (Act s 41FN)
  • 5.10 Conditions applying automatically--record - keeping (Act s 41FN)
  • 5.11 Conditions applying automatically--reporting (Act s 41FN)
  • 5.12 Conditions applying automatically--notification of information (Act s 41FN)
  • 5.13 Conditions applying automatically--information about poisons (Act s 41FN)

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

  • 7.3 Conditions of approval--use of device by person to whom approval is given (Act s 41HB)
  • 7.4 Powers of authorised persons in relation to medical devices being used in clinical trials
  • 7.5 Conditions of approval--use of device by another person (Act s 41HB)

Division 7.3--Exemptions for medical practitioners

  • 7.6 Classes of medical practitioners and recipients (Act s 41HC)
  • 7.7 Circumstances for supply of device under authority (Act s 41HC)
  • 7.8 Information to be notified in relation to supply of certain medical devices

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

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

  • 9.1A Purposes of this Division
  • 9.1B Conformity assessment body determination assessment fees
  • 9.1C Conformity assessment body determination assessment fees--abridged assessment
  • 9.1D Payment of conformity assessment body determination assessment fees by instalments
  • 9.1E Recovery of conformity assessment body determination assessment fees
  • 9.1F Refund of conformity assessment body determination assessment fees if applications withdrawn

Division 9.3--Assessment fees and reductions or refunds of fees connected with applications for conformity assessment certificates

  • 9.2 Application audit assessment fee (Act ss 41LA, 41LB)
  • 9.3 Conformity assessment fee (Act ss 41LA, 41LB)
  • 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
  • 9.8 Refund of fees--kinds of medical devices covered by former regulation 4.1

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
  • 11.3 Application of this Subdivision
  • 11.4 Transitional devices exempted from requirement to be included in the Register
  • 11.5 Essential principles for transitional devices
  • Subdivision C--Listed or registered transitional devices and exempt transitional devices
  • 11.6 Application of this Subdivision
  • 11.7 Application of 2010 Amendment Regulations--certain purposes
  • 11.8 Application of 2010 Amendment Regulations--conformity assessment certificate required and applied for before 1 September 2014
  • 11.9 Application of 2010 Amendment Regulations--conformity assessment certificate required but not applied for before 1 September 2014
  • 11.10 Application of 2010 Amendment Regulations--conformity assessment certificate not required
  • 11.11 Cancellation of listing or registration
  • Subdivision D--Approved transitional devices
  • 11.12 Application of this Subdivision
  • 11.13 Application of 2010 Amendment Regulations--certain purposes
  • 11.14 Application of 2010 Amendment Regulations--all purposes
  • Subdivision E--Class 4 in-house IVD medical devices
  • 11.15 Application of this Subdivision
  • 11.16 Application of 2010 Amendment Regulations--certain purposes
  • 11.17 Application of 2010 Amendment Regulations--conformity assessment certificate applied for before 1 July 2016
  • 11.18 Application of 2010 Amendment Regulations--devices not covered by regulation 11.17
  • 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

Division 11.5--Transitional provisions relating to the Therapeutic Goods (Medical Devices) Amendment (Implantable Medical Devices) Regulations 2017

Division 11.6--Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017

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
  • 11.39 Definitions
  • 11.40 Transitional medical devices--application of amendments
  • 11.41 Transitional medical devices--Secretary must be notified of unique product identifiers of devices supplied under pre - commencement entries
  • 11.42 Transitional medical devices--selecting applications for auditing
  • 11.43 Waiver of certain application fees
  • Subdivision C--Programmed or programmable medical device or software that is a medical device
  • 11.44 Definitions
  • 11.45 Programmed or programmable medical device or software that is a medical device--classification rules
  • 11.46. Secretary must be notified in relation to a transitional kind of medical device
  • 11.47 Programmed or programmable medical device or software that is a medical device--essential principles
  • Subdivision D--Personalised medical devices
  • 11.48 Definitions
  • 11.49 Personalised medical devices--reports
  • 11.50 Personalised medical devices--conformity assessment procedures
  • 11.51 Personalised medical devices--exemptions
  • 11.52 Personalised medical devices--classification rules
  • 11.53. Secretary must be notified in relation to a transitional kind of medical device 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

Division 11.18--Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023

Division 11.19--Application provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023

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