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
11.73 Application of amendments
http://www.austlii.edu.au/au/legis/cth/consol_reg/tgdr2002400/