Commonwealth Consolidated Regulations

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

   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

   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

   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

   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  
           SCHEDULE 1 Essential principles
           SCHEDULE 2 Classification rules for medical devices other than IVD medical devices
           SCHEDULE 2A Classification rules for IVD medical devices
           SCHEDULE 3 Conformity assessment procedures
           SCHEDULE 3AA Requirements for Australian conformity assessment bodies
           SCHEDULE 3A Disposal of unused emergency medical devices
           SCHEDULE 4 Exempt devices
           SCHEDULE 5 Fees