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THERAPEUTIC GOODS (MEDICAL DEVICES) REGULATIONS 2002 - NOTES

- made under the Therapeutic Goods Act 1989

Statutory Rules No. 236, 2002

made under the

Therapeutic Goods Act 1989

Compilation No. 61

Compilation date: 1 January 2024

Includes amendments: F2023L01667

Registered: 17 January 2024

About this compilation

This compilation

This is a compilation of the Therapeutic Goods (Medical Devices) Regulations 2002 that shows the text of the law as amended and in force on 1 January 2024 (the compilation date).

The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of provisions of the compiled law.

Uncommenced amendments

The effect of uncommenced amendments is not shown in the text of the compiled law. Any uncommenced amendments affecting the law are accessible on the Register (www.legislation.gov.au). The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. For more information on any uncommenced amendments, see the Register for the compiled law.

Application, saving and transitional provisions for provisions and amendments

If the operation of a provision or amendment of the compiled law is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes.

Editorial changes

For more information about any editorial changes made in this compilation, see the endnotes.

Modifications

If the compiled law is modified by another law, the compiled law operates as modified but the modification does not amend the text of the law. Accordingly, this compilation does not show the text of the compiled law as modified. For more information on any modifications, see the Register for the compiled law.

Self-repealing provisions

If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.

 

 

 

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

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

Part 1--General principles

1 Use of medical devices not to compromise health and safety

2 Design and construction of medical devices to conform with safety principles

3 Medical devices to be suitable for intended purpose

4 Long-term safety

5 Medical devices not to be adversely affected by transport or storage

6 Benefits of medical devices to outweigh any undesirable effects

Part 2--Principles about design and construction

7 Chemical, physical and biological properties

7.1 Choice of materials

7.2 Minimisation of risks associated with contaminants and residues

7.3 Ability to be used safely with materials etc

7.4 Verification of incorporated substance

7.5 Minimisation of risks associated with leaching substances

7.6 Minimisation of risks associated with ingress or egress of substances

7.7 Minimisation of risks associated with nanomaterials

8 Infection and microbial contamination

8.1 Minimisation of risk of infection and contamination

8.2 Control of animal, microbial or recombinant tissues, tissue derivatives, cells and other substances

8.3 Medical devices to be supplied in a sterile state

8.4 Medical devices to be supplied in a non-sterile state

8.5 Distinction between medical devices supplied in sterile and non-sterile state

9 Construction and environmental properties

9.1 Medical devices intended to be used in combination with other devices or equipment

9.2 Minimisation of risks associated with use of medical devices

10 Medical devices with a measuring function

11 Protection against radiation

11.1 Minimisation of exposure to radiation

11.2 Medical devices intended to emit radiation

11.3 Minimisation of exposure to unintended radiation

11.4 Operating instructions

11.5 Medical devices intended to emit ionising radiation--additional requirements

12 Medical devices connected to or equipped with an energy source

12.1 Programmed or programmable medical device or software that is a medical device

12.2 Safety dependent on internal power supply

12.3 Safety dependent on external power supply

12.4 Medical devices intended to monitor clinical parameters

12.5 Minimisation of risk of electromagnetic fields

12.6 Protection against electrical risks

12.7 Protection against mechanical risks

12.8 Protection against risks associated with vibration

12.9 Protection against risks associated with noise

12.10 Protection against risks associated with terminals and connectors

12.11 Protection against risks associated with heat

12.12 Protection against risks associated with administration of energy or substances

12.13 Active implantable medical devices

13 Information to be provided with medical devices

13.1 Information to be provided with medical devices--general

13.2 Information to be provided with medical devices--location

13.3 Information to be provided with medical devices--particular requirements

13.4 Instructions for use

13A Patient information about implantable medical devices or active implantable medical devices to be made available

13A.1 Scope of clauses 13A.2 to 13A.4

13A.2 Patient implant cards etc. for implantable devices

13A.3 Patient information leaflets etc. for implantable devices

13A.4 General requirements for information to be made available for patients

13B Software--version numbers and build numbers

14 Clinical evidence

15 Principles applying to IVD medical devices only

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

2.1 Non-invasive medical devices--general

2.2 Non-invasive medical devices intended to channel or store blood, etc

2.3 Non-invasive medical devices intended to modify the biological or chemical composition of blood, etc

2.4 Non-invasive medical devices intended to have contact with injured skin or mucous membrane

Part 3--Rules for invasive medical devices and implantable medical devices

3.1 Invasive medical devices intended to be used by penetration of body orifices

3.2 Surgically invasive medical devices intended for transient use

3.3 Surgically invasive medical devices intended for short-term use

3.4 Surgically invasive medical devices intended for long-term use and implantable medical devices

Part 4--Special rules for active medical devices

4.1 Active medical devices--general

4.2 Active medical devices for therapy

4.3 Active medical devices for diagnosis

4.4 Active medical devices intended to administer or remove medicines, etc from a patient's body

4.5 Programmed or programmable medical device or software that is a medical device for use in relation to diagnosing or screening for a disease or condition

4.6 Programmed or programmable medical device or software that is a medical device for use for monitoring the state or progression of a disease or condition etc.

4.7 Programmed or programmable medical device or software that is a medical device for use in specifying or recommending treatment or intervention

4.8 Programmed or programmable medical device or software that is a medical device that is to provide therapy to a person through the provision of information

Part 5--Special rules for particular kinds of medical devices

5.1 Medical devices incorporating a medicine

5.2 Medical devices intended for contraception or prevention of sexually transmitted diseases

5.3 Medical devices intended for disinfecting, cleaning, etc

5.4 Medical devices that record patient images or that are anatomical models etc.

5.5 Medical devices containing non-viable animal tissues, cells or other substances, or microbial or recombinant tissues, cells or other substances

5.6 Medical devices that are blood bags

5.7 Active implantable medical devices

5.8 Medical devices intended for export only

5.9 Medical devices that are mammary implants

5.10 Medical devices that administer medicines or biologicals by inhalation

5.11 Medical devices that are substances to be introduced into the body or applied to and absorbed by the skin

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

1.1 Overview

1.2 References to kinds of medical devices

1.3 Implementation and assessment of quality management system

1.4 Requirements of quality management system

1.5 Changes to quality management system or kinds of medical device to which system is to be applied

1.6 Examination of design of Class 4 IVD medical device, Class 4 in-house IVD medical device or Class III medical device

1.7 Information to be given to authorised person

1.8 Declaration of conformity

1.9 Records

Part 2--Type examination procedures

2.1 Overview

2.2 References to kinds of medical devices

2.3 Examination of type

2.4 Changes to design of medical device after examination

2.5 Records

Part 3--Verification procedures

3.1 Overview

3.2 References to kinds of medical devices

3.3 Verification of conformity

3.4 Requirements of manufacturing system

3.5 Declaration of conformity

3.6 Records

Part 4--Production quality assurance procedures

4.1 Overview

4.2 References to kinds of medical devices

4.3 Implementation and assessment of production quality management system

4.4 Requirements of production quality management system

4.5 Changes to production quality management system

4.6 Information to be given to authorised person

4.7 Declaration of conformity

4.8 Records

Part 5--Product quality assurance procedures

5.1 Overview

5.2 References to kinds of medical devices

5.3 Implementation and assessment of product quality management system

5.4 Requirements of product quality management system

5.5 Changes to product quality management system or kinds of medical device

5.6 Information to be given to authorised person

5.7 Declaration of conformity

5.8 Records

Part 6--Declaration of conformity (not requiring assessment by Secretary) procedures

6.1 Overview

6.2 References to kinds of medical devices

6.3 Implementation

6.4 Required technical documentation

6.5 Post-marketing system

6.6 Declaration of conformity

6.7 Records

Part 6A--Procedures applying to Class 1, 2 and 3 in-house IVD medical devices

6A.1 Overview

6A.2 Procedures

6A.3 Information to be given to the Secretary

6A.4 Post-marketing system

Part 6B--Procedures applying to Class 4 in-house IVD medical devices

6B.1 Overview

6B.2 References to kinds of medical devices

6B.3 Procedures

6B.4 Required technical documentation

6B.5 Post-marketing system

6B.6 Declaration of conformity

6B.7 Records

6B.8 Notification of certain Class 4 in-house IVD medical devices being manufactured

Part 7--Procedures for medical devices used for a special purpose

7.1 Overview

7.2 Custom-made medical devices

7.5 System or procedure packs

7.6 Records

Part 8--Clinical evaluation procedures

8.1 Overview

8.2 References to kinds of medical devices

8.3 Obtaining clinical data

8.4 Clinical investigation data

8.5 Literature review

8.6 Evaluation of clinical data

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

Endnote 1--About the endnotes

Endnote 2--Abbreviation key

Endnote 3--Legislation history

Endnote 4--Amendment history

 

Endnotes

Endnote 1--About the endnotes

The endnotes provide information about this compilation and the compiled law.

The following endnotes are included in every compilation:

Endnote 1--About the endnotes

Endnote 2--Abbreviation key

Endnote 3--Legislation history

Endnote 4--Amendment history

Abbreviation key--Endnote 2

The abbreviation key sets out abbreviations that may be used in the endnotes.

Legislation history and amendment history--Endnotes 3 and 4

Amending laws are annotated in the legislation history and amendment history.

The legislation history in endnote 3 provides information about each law that has amended (or will amend) the compiled law. The information includes commencement details for amending laws and details of any application, saving or transitional provisions that are not included in this compilation.

The amendment history in endnote 4 provides information about amendments at the provision (generally section or equivalent) level. It also includes information about any provision of the compiled law that has been repealed in accordance with a provision of the law.

Editorial changes

The Legislation Act 2003 authorises First Parliamentary Counsel to make editorial and presentational changes to a compiled law in preparing a compilation of the law for registration. The changes must not change the effect of the law. Editorial changes take effect from the compilation registration date.

If the compilation includes editorial changes, the endnotes include a brief outline of the changes in general terms. Full details of any changes can be obtained from the Office of Parliamentary Counsel.

Misdescribed amendments

A misdescribed amendment is an amendment that does not accurately describe how an amendment is to be made. If, despite the misdescription, the amendment can be given effect as intended, then the misdescribed amendment can be incorporated through an editorial change made under section  15V of the Legislation Act 2003.

If a misdescribed amendment cannot be given effect as intended, the amendment is not incorporated and "(md not incorp)" is added to the amendment history.

 

Endnote 2--Abbreviation key

 

ad = added or inserted

o = order(s)

am = amended

Ord = Ordinance

amdt = amendment

orig = original

c = clause(s)

par = paragraph(s)/subparagraph(s)

C[x] = Compilation No. x

/sub-subparagraph(s)

Ch = Chapter(s)

pres = present

def = definition(s)

prev = previous

Dict = Dictionary

(prev ... ) = previously

disallowed = disallowed by Parliament

Pt = Part(s)

Div = Division(s)

r = regulation(s)/rule(s)

ed = editorial change

reloc = relocated

exp = expires/expired or ceases/ceased to have

renum = renumbered

effect

rep = repealed

F = Federal Register of Legislation

rs = repealed and substituted

gaz = gazette

s = section(s)/subsection(s)

LA = Legislation Act 2003

Sch = Schedule(s)

LIA = Legislative Instruments Act 2003

Sdiv = Subdivision(s)

(md) = misdescribed amendment can be given

SLI = Select Legislative Instrument

effect

SR = Statutory Rules

(md not incorp) = misdescribed amendment

Sub-Ch = Sub-Chapter(s)

cannot be given effect

SubPt = Subpart(s)

mod = modified/modification

underlining = whole or part not

No. = Number(s)

commenced or to be commenced

 

Endnote 3--Legislation history

 

Number and year

FRLI registration or gazettal

Commencement

Application, saving and transitional provisions

2002 No. 236

4 Oct 2002

4 Oct 2002

 

2003 No. 153

26 June 2003

1 July 2003

--

2003 No. 259

16 Oct 2003

rr. 1-3 and Schedule 1: 16 Oct 2003
Remainder: 4 Oct 2007

--

2003 No. 361

23 Dec 2003

23 Dec 2003

--

2004 No. 78

30 Apr 2004

30 Apr 2004

--

2004 No. 128

18 June 2004

1 July 2004

--

2005 No. 193

19 Aug 2005 (F2005L02313)

20 Aug 2005

--

2006 No. 214

10 Aug 2006 (F2006L02575)

11 Aug 2006

--

2007 No. 163

25 June 2007 (F2007L01522)

1 July 2007

--

2008 No. 119

20 June 2008 (F2008L01366)

1 July 2008

--

2008 No. 270

18 Dec 2008 (F2008L04296)

19 Dec 2008

--

2009 No. 181

9 July 2009 (F2009L02090)

10 July 2009

--

2010 No. 25

3 Mar 2010 (F2010L00469)

1 July 2010

rr. 4-7

2010 No. 132

18 June 2010 (F2010L01281)

1 July 2010

--

2010 No. 267

29 Oct 2010 (F2010L02787)

30 Oct 2010

--

2011 No. 32

16 Mar 2011 (F2011L00430)

31 May 2011 (see r. 2)

--

2011 No. 104

21 June 2011 (F2011L01102)

1 July 2011

--

2011 No. 282

9 Dec 2011 (F2011L02627)

10 Dec 2011

--

2012 No. 146

29 June 2012 (F2012L01464)

1 July 2012

--

2012 No. 147

29 June 2012 (F2012L01466)

1 July 2012

--

94, 2013

3 June 2013 (F2013L00896)

Sch 1 (item 2): 1 July 2013

--

38, 2014

26 Mar 2014 (F2014L00349)

27 Mar 2014

--

44, 2014

30 Apr 2014 (F2014L00456)

1 May 2014

--

62, 2014

30 May 2014 (F2014L00630)

1 July 2014

--

63, 2014

30 May 2014 (F2014L00632)

1 July 2014

--

159, 2014

3 Nov 2014 (F2014L01465)

5 Nov 2014 (s 2)

--

196, 2014

16 Dec 2014 (F2014L01716)

17 Dec 2014 (s 2)

--

46, 2015

20 Apr 2015 (F2015L00574)

21 Apr 2015 (s 2)

--

75, 2015

1 June 2015 (F2015L00778)

Sch 1 (items 7, 8): 1 July 2015 (s 2)

--

87, 2015

18 June 2015 (F2015L00837)

Sch 1 (item 1): 1 July 2015 (s 2(1) item 1)

--

90, 2015

19 June 2015 (F2015L00854)

Sch 2 (item 196): 1 July 2015 (s 2(1) item 2)

--

188, 2015

13 Nov 2015 (F2015L01791)

14 Nov 2015 (s 2(1) item 1)

--

 

Name

Registration

Commencement

Application, saving and transitional provisions

Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016

15 Feb 2016 (F2016L00109)

Sch 3: 16 Feb 2016 (s 2(1) item 3)

--

Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulation 2016

5 May 2016 (F2016L00667)

Sch 1 (item 1): 1 July 2016 (s 2(1) item 1)

--

Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2017

19 May 2017 (F2017L00552)

Sch 1 (items 1, 2): 1 July 2017 (s 2(1) item 1)

--

Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017

30 June 2017 (F2017L00853)

Sch 2 (items 1-6), Sch 6 (item 1) and Sch 8 (items 1-6): 1 July 2017 (s 2(1) item  4)

--

Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017

1 Dec 2017 (F2017L01561)

Sch 1: 1 Jan 2018 (s 2(1) item 2)
Sch 4 (items 5, 7-10): 2 Dec 2017 (s 2(1) item 6)

--

Therapeutic Goods (Medical Devices) Amendment (Implantable Medical Devices) Regulations 2017

20 Dec 2017 (F2017L01692)

1 Dec 2018 (s 2(1) item 1)

--

Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018

19 Mar 2018 (F2018L00311)

Sch 3, Sch 6 (items 1-8) and Sch 7: 20 Mar 2018 (s 2(1) items 4, 8)

--

Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018

26 Apr 2018 (F2018L00516)

Sch 1 (items 1-5): 27 Apr 2018 (s 2(1) item 1)

--

Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2018

12 June 2018 (F2018L00759)

Sch 1 (items 1-4): 1 July 2018 (s 2(1) item 2)

--

Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018

25 June 2018 (F2018L00865)

Sch 1 (items 1-3): 1 July 2018 (s 2(1) item 2)

--

Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018

15 Oct 2018 (F2018L01434)

Sch 1 (items 1, 2, 35, 36): 16 Oct 2018 (s 2(1) item 2)

--

Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2019

25 Mar 2019 (F2019L00396)

Sch 1 (items 1-3): 1 July 2019 (s 2(1) item 2)

--

Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019

18 Dec 2019 (F2019L01660)

Sch 1 (items 1-43): 25 Nov 2021 (s 2(1) item 2)
Sch 2 and 3: 25 Feb 2021 (s 2(1) item 2A)
Sch 4: 1 Feb 2020 (s 2(1) item 3)
Sch 10 (item 1): 19 Dec 2019 (s 2(1) item 10)

--

as amended by

 

 

 

Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020

23 July 2020 (F2020L00946)

Sch 8 (item 1): 24 July 2020 (s 2(1) item 7)

--

Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2020

15 June 2020 (F2020L00720)

Sch 1 (items 1, 3): 1 July 2020 (s 2(1) item 1)

--

Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020

23 July 2020 (F2020L00946)

Sch 1: 25 Aug 2020 (s 2(1) item 2)
Sch 2, 3, 7, Sch 8 (items 2-23) and Sch 10 (item 1): 24 July 2020 (s 2(1) items 3, 6, 7, 9)
Sch 8 (item 32): 25 Nov 2021 (s 2(1) item 8)

--

Therapeutic Goods Legislation Amendment (2020 Measures No. 2) Regulations 2020

14 Dec 2020 (F2020L01598)

Sch 1 (items 1, 2): 25 Feb 2021 (s 2(1) item 2)

--

Therapeutic Goods (Medical Devices) Amendment (Vaporisers for Smoking Cessation) Regulations 2020

18 Dec 2020 (F2020L01645)

19 Dec 2020 (s 2(1) item 1)

--

Therapeutic Goods Legislation Amendment (2021 Measures No. 1) Regulations 2021

16 Apr 2021 (F2021L00450)

Sch 2: 17 Apr 2021 (s 2(1) item 4)

--

Therapeutic Goods Legislation Amendment (Fees) Regulations 2021

3 June 2021 (F2021L00688)

Sch 1 (item 1): 1 July 2021 (s 2(1) item 1)

--

Therapeutic Goods Legislation Amendment (2021 Measures No. 2) Regulations 2021

27 July 2021 (F2021L01032)

Sch 1 (items 3-5, 9-12, 14): 28 July 2021 (s 2(1) item 1)

--

Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021

28 Oct 2021 (F2021L01474)

Sch 1 (items 14-37, 44-48, 50-53, 62-69, 83-86): 29 Oct 2021 (s 2(1) items 3, 5, 7)
Sch 1 (items 1-13, 38-43, 49): 25 Nov 2021 (s 2(1) items 2, 4, 6)

--

Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021

17 Dec 2021 (F2021L01809)

Sch 1 (items 1-4): 18 Dec 2021 (s 2(1) item 2)

--

Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022

4 Mar 2022 (F2022L00243)

Sch 3 (items 1-3): 5 Mar 2022 (s 2(1) item 4)

--

Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2022

13 Apr 2022 (F2022L00600)

Sch 1 (items 1-4): 1 July 2022 (s 2(1) item 1)

--

Therapeutic Goods Legislation Amendment (2022 Measures No. 2) Regulations 2022

30 Sept 2022 (F2022L01300)

Sch 1: 1 July 2022 (s 2(1) item 2)
Sch 2: 1 Oct 2022 (s 2(1) item 3)

--

Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022

19 Dec 2022 (F2022L01687)

Sch 1: 20 Dec 2022 (s 2(1) item 1)

--

Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023

13 June 2023 (F2023L00769)

Sch 1 (items 14-19, 29, 31-51, 53): 14 June 2023 (s 2(1) item 3)

--

Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2023

13 June 2023 (F2023L00770)

Sch 1 (items 1-6): 1 July 2023 (s 2(1) item 1)

--

Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023

27 Nov 2023 (F2023L01558)

Sch 1 (items 1-12, 33): 28 Nov 2023 (s 2(1) items 2, 4)

--

Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023

14 Dec 2023 (F2023L01667)

Sch 2: 1 Jan 2024 (s 2(1) item 1)

--

 

Endnote 4--Amendment history

 

Provision affected

How affected

Part 1

 

r 1.2....................

rep LA s 48D

r 1.4....................

am F2016L00109

r 1.6....................

rs No 25, 2010

 

am F2019L01660

r 1.7....................

am No 25, 2010; F2019L01660

r 1.8....................

ad F2019L01660

Part 3

 

Division 3.1

 

r 3.1....................

rs No 25, 2010

 

am F2019L01660

r. 3.2....................

rs. 2010 No. 25

r 3.3....................

am No 25, 2010; F2019L01660

Division 3.2

 

r. 3.4....................

am. 2010 No. 25

r 3.5....................

am No 159, 2014

r 3.6....................

am F2019L01660

r. 3.6A..................

ad. 2010 No. 25

 

am No 188, 2015

r 3.6B...................

ad No 188, 2015

r. 3.7A..................

ad. 2010 No. 25

r. 3.7B..................

ad. 2010 No. 25

r. 3.8A..................

ad. 2010 No. 25

r. 3.8B..................

ad. 2010 No. 25

r. 3.9A..................

ad. 2010 No. 25

r. 3.9B..................

ad. 2010 No. 25

r 3.10...................

am No 25, 2010; No 32, 2011; F2020L00946; F2021L01474

r 3.11...................

am F2019L01660

Part 4

 

Division 4.1

 

r. 4.1....................

am No 25, 2010; No 159, 2014; No 188, 2015

 

rep F2021L01032

Division 4.1A

 

Division 4.1A..............

ad F2017L01561

r 4.3A...................

ad F2017L01561

r 4.3B...................

ad F2017L01561

r 4.3C...................

ad F2017L01561

r 4.3D...................

ad F2017L01561

r 4.3E...................

ad F2017L01561

Division 4.1B

 

Division 4.1B..............

ad F2018L00311

r 4.3F...................

ad F2018L00311

 

am F2019L01660

Division 4.1C

 

Division 4.1C..............

ad F2018L00865

r 4.3G...................

ad F2018L00865

Part 4A

 

Part 4A..................

ad F2018L00311

Division 4A.1

 

r 4A.1...................

ad F2018L00311

Division 4A.2

 

r 4A.2...................

ad F2018L00311

r 4A.3...................

ad F2018L00311

r 4A.4...................

ad F2018L00311

r 4A.5...................

ad F2018L00311

r 4A.6...................

ad F2018L00311

 

am F2022L00600

r 4A.7...................

ad F2018L00311

r 4A.8...................

ad F2018L00311

r 4A.9...................

ad F2018L00311

Division 4A.3

 

Subdivision A

 

r 4A.10..................

ad F2018L00311

r 4A.11..................

ad F2018L00311

r 4A.12..................

ad F2018L00311

r 4A.13..................

ad F2018L00311

r 4A.14..................

ad F2018L00311

r 4A.15..................

ad F2018L00311

r 4A.16..................

ad F2018L00311

r 4A.17..................

ad F2018L00311

r 4A.18..................

ad F2018L00311

Subdivision B

 

r 4A.19..................

ad F2018L00311

Division 4A.4

 

r 4A.20..................

ad F2018L00311

r 4A.21..................

ad F2018L00311

r 4A.22..................

ad F2018L00311

r 4A.23..................

ad F2018L00311

r 4A.24..................

ad F2018L00311

Division 4A.5

 

r 4A.25..................

ad F2018L00311

r 4A.26..................

ad F2018L00311

r 4A.27..................

ad F2018L00311

Division 4A.6

 

r 4A.28..................

ad F2018L00311

r 4A.29..................

ad F2018L00311

r 4A.30..................

ad F2018L00311

Division 4A.7

 

r 4A.31..................

ad F2018L00311

 

am F2019L01660

Part 5

 

Division 5.1

 

Subdivision A

 

Subdivision A heading........

ad F2017L01561

Subdivision C

 

Subdivision C heading........

ad F2017L01561

r 5.3....................

am No 25, 2010; No 282, 2011; No 38, 2014; No 159, 2014; No 188, 2015; F2016L00109; F2018L00311; F2018L01434; F2019L01660; F2021L01032

Subdivision D

 

Subdivision D.............

ad F2017L01561

r 5.4....................

rep No 282, 2011

 

ad F2017L01561

r 5.4A...................

ad F2017L01561

r 5.4B...................

ad F2017L01561

r 5.4C...................

ad F2017L01561

 

am F2018L00311

r 5.4D...................

ad F2017L01561

 

am F2018L00311

Division 5.2

 

r 5.6....................

rep F2023L00769

r 5.7....................

am F2020L00946; F2021L01474

r 5.8A...................

ad F2021L01474

r 5.9....................

ad F2017L00853

r 5.10...................

ad F2017L00853

 

am F2019L01660

r 5.11...................

ad F2017L00853

 

am F2019L01660; F2020L00946

r 5.12...................

ad F2017L00853

 

am F2019L01660

r 5.13...................

ad F2018L00865

 

am F2018L01434

Part 6A

 

Part 6A..................

ad. 2010 No. 267

r. 6A.1..................

ad. 2010 No. 267

Part 7

 

Division 7.1

 

r 7.1....................

am F2021L01032; F2021L01474; F2023L01667

r 7.2....................

am F2017L01561; F2018L00311

Division 7.2

 

r 7.3....................

am F2016L00109

r 7.4....................

am F2023L00769; F2023L01558

r 7.5....................

am F2020L00946

Division 7.3

 

r 7.7....................

am F2017L00853

r 7.8....................

ad F2017L00853

Part 8

 

r. 8.1A..................

ad. 2011 No. 104

 

am No 75, 2015; F2016L00109

r 8.1....................

am F2019L01660

r 8.2....................

am F2017L00853

 

rep F2017L01561

Part 8A

 

Part 8A..................

ad F2023L00770

r 8A.1...................

ad F2023L00770

r 8A.2...................

ad F2023L00770

r 8A.3...................

ad F2023L00770

Part 9

 

Division 9.1

 

Division 9.1 heading.........

ad F2018L00311

Division 9.1A

 

Division 9.1A heading........

am F2022L01300

Division 9.1A..............

ad F2021L01474

r 9.1AA..................

ad F2021L01474

 

am F2022L01300; F2022L01687

Division 9.2

 

Division 9.2...............

ad F2018L00311

r 9.1A...................

ad F2018L00311

r 9.1B...................

ad F2018L00311

r 9.1C...................

ad F2018L00311

r 9.1D...................

ad F2018L00311

r 9.1E...................

ad F2018L00311

r 9.1F...................

ad F2018L00311

Division 9.3

 

Division 9.3 heading.........

ad F2018L00311

 

am F2021L01474

r 9.2....................

am 2011 No 282

r 9.4....................

am 2003 No 153; 2004 No 128; 2005 No 193; 2006 No 214; 2007 No 163; 2008 No  119; 2009 No 181; 2010 No 132; 2011 No 104; 2012 No 147; No 94, 2013; No 62, 2014; No 87, 2015; F2016L00667; F2017L00552

 

rep F2018L00759

r. 9.6....................

ad. 2003 No. 153

r. 9.7....................

ad. 2003 No. 153

 

am. 2010 No. 267; No 188, 2015

r 9.8....................

ad F2021L01474

Division 9.4

 

Division 9.4...............

ad F2021L01474

r 9.9....................

ad F2021L01474

Part 10

 

r. 10.1...................

rs. 2003 No. 361

r. 10.2...................

am. 2003 No. 259

r 10.3...................

am F2016L00109

r 10.3A..................

ad F2019L01660

r 10.4AA.................

ad F2020L00946

r 10.4A..................

ad No 196, 2014

r 10.5...................

am F2016L00109

r 10.6A..................

ad F2016L00109

 

am F2017L00853; F2017L01561; F2023L00769

r 10.6B..................

ad F2018L00311

r 10.7...................

am F2016L00109; F2017L01561; F2018L00311; F2021L01474; F2023L00769

 

ed C58

 

am F2023L00770; F2023L01558; F2023L01667

Part 11

 

Part 11 heading.............

rs No 63, 2014

Part 11..................

ad. 2012 No. 146

Division 11.1

 

Division 11.1..............

ad No 63, 2014

Subdivision A

 

r 11.1...................

ad No 63, 2014

 

am No 188, 2015; F2018L00311

r 11.2...................

ad No 63, 2014

Subdivision B

 

r 11.3...................

ad No 63, 2014

r 11.4...................

ad No 63, 2014

r 11.5...................

ad No 63, 2014

Subdivision C

 

r 11.6...................

ad No 63, 2014

r 11.7...................

ad No 63, 2014

r 11.8...................

ad No 63, 2014

 

am F2018L00311

r 11.9...................

ad No 63, 2014

r 11.10..................

ad No 63, 2014

r 11.11..................

ad No 63, 2014

Subdivision D

 

r 11.12..................

ad No 63, 2014

r 11.13..................

ad No 63, 2014

r 11.14..................

ad No 63, 2014

Subdivision E

 

r 11.15..................

ad No 63, 2014

 

am No 188, 2015

r 11.16..................

ad No 63, 2014

r 11.17..................

ad No 63, 2014

 

am No 188, 2015; F2018L00311

r 11.18..................

ad No 63, 2014

 

rs No 188, 2015

 

am F2018L00311

r 11.19..................

ad No 63, 2014

 

rep No 188, 2015

Subdivision F

 

r 11.20..................

ad No 63, 2014

 

am No 188, 2015

r 11.21..................

ad No 63, 2014

 

rs No 188, 2015

Division 11.2

 

Division 11.2 heading........

ad No 63, 2014

 

rs No 46, 2015

r 11.22A.................

ad No 46, 2015

r 11.22 (prev r 11.1)..........

ad No 146, 2012

 

am No 38, 2014; No 44, 2014

 

renum No 63, 2014

 

am No 46, 2015

r 11.23..................

ad No 46, 2015

Division 11.3

 

Division 11.3..............

ad No 188, 2015

r 11.24..................

ad No 188, 2015

r 11.25..................

ad No 188, 2015

r 11.26..................

ad No 188, 2015

Division 11.4

 

Division 11.4..............

ad F2016L00109

r 11.27..................

ad F2016L00109

Division 11.5

 

Division 11.5..............

ad F2017L01692

r 11.28..................

ad F2017L01692

r 11.29..................

ad F2017L01692

 

am F2021L01474

r 11.30..................

ad F2017L01692

 

rep F2021L01474

r 11.31..................

ad F2017L01692

Division 11.6

 

Division 11.6..............

ad F2017L01561

r 11.32..................

ad F2017L01561

r 11.33..................

ad F2017L01561

Division 11.7

 

Division 11.7..............

ad F2018L00516

r 11.34..................

ad F2018L00516

Division 11.8

 

Division 11.8..............

ad F2018L00865

r 11.35..................

ad F2018L00865

r 11.36..................

ad F2018L00865

Division 11.9

 

Division 11.9..............

ad F2018L01434

r 11.37..................

ad F2018L01434

Division 11.10

 

Division 11.10.............

ad F2019L01660

Subdivision A

 

r 11.38..................

ad F2019L01660

Subdivision B

 

r 11.39..................

ad F2019L01660

 

am F2020L00946; F2021L01474

r 11.40..................

ad F2019L01660

 

am F2020L00946; F2021L01474; F2023L01558

r 11.41..................

ad F2019L01660

 

am F2020L00946

r 11.42..................

ad F2019L01660

r 11.43..................

ad F2019L01660

 

am F2020L00946

 

exp end of 24 Nov 2022 (r 11.43(3))

Subdivision C

 

r 11.44..................

ad F2019L01660

 

am F2020L00946

r 11.45..................

ad F2019L01660

 

am F2020L00946

r 11.46..................

ad F2019L01660

 

am F2020L00946

r 11.47..................

ad F2019L01660

 

am F2020L00946

Subdivision D

 

r 11.48..................

ad F2019L01660

 

am F2020L00946

r 11.49..................

ad F2019L01660

 

am F2020L00946

r 11.50..................

ad F2019L01660

 

am F2020L00946

r 11.51..................

ad F2019L01660

 

am F2020L00946; F2021L00450; F2023L01558; F2023L01667

r 11.52..................

ad F2019L01660

 

am F2020L00946; F2023L01558

r 11.53..................

ad F2019L01660

 

am F2020L00946

Subdivision E

 

r 11.54..................

ad F2019L01660

 

am F2022L01300

Division 11.11

 

Division 11.11.............

ad F2020L00946

r 11.55..................

ad F2020L00946

r 11.56..................

ad F2020L00946

r 11.57..................

ad F2020L00946

Division 11.12

 

Division 11.12.............

ad F2021L01032

r 11.58..................

ad F2021L01032

 

am F2023L01667

Division 11.13

 

Division 11.13.............

ad F2021L01474

r 11.59..................

ad F2021L01474

r 11.60..................

ad F2021L01474

r 11.61..................

ad F2021L01474

r 11.62..................

ad F2021L01474

r 11.63..................

ad F2021L01474

r 11.64..................

ad F2021L01474

r 11.65..................

ad F2021L01474

 

rep F2023L01667

r 11.66..................

ad F2021L01474

Division 11.14

 

Division 11.14.............

ad F2021L01809

r 11.67..................

ad F2021L01809

Division 11.15

 

Division 11.15.............

ad F2022L01300

r 11.68..................

ad F2022L01300

Division 11.16

 

Division 11.16.............

ad F2022L01687

r 11.69..................

ad F2022L01687

r 11.70..................

ad F2022L01687

Division 11.17

 

Division 11.17.............

ad F2023L00769

r 11.71..................

ad F2023L00769

Division 11.18

 

Division 11.18.............

ad F2023L01558

r 11.72..................

ad F2023L01558

Division 11.19

 

Division 11.19.............

ad F2023L01667

r 11.73..................

ad F2023L01667

Schedule 1

 

Schedule 1................

am No 259, 2003; No 25, 2010; F2016L00109

 

ed C33

 

am F2017L01692

 

ed C39

 

am F2019L01660; F2021L01474; F2021L01809; F2022L00243; F2022L01687

Schedule 2

 

Schedule 2 heading..........

rs No 25, 2010

Schedule 2................

am F2019L01660

Part 1

 

c 1.1....................

am F2019L01660

Part 2

 

c 2.4....................

am F2019L01660

Part 3

 

c 3.1....................

am F2019L01660; F2021L01474

c 3.2....................

am F2019L01660; F2021L01474

c 3.3....................

am F2019L01660

c 3.4....................

am No 146, 2012; No 46, 2015; F2017L01692; F2019L01660; F2021L01474

Part 4

 

c 4.2....................

am F2019L01660

c 4.3....................

ed C32

c 4.5....................

ad F2019L01660

c 4.6....................

ad F2019L01660

c 4.7....................

ad F2019L01660

c 4.8....................

ad F2019L01660

Part 5

 

c 5.4....................

rs F2019L01660

c 5.7....................

am F2019L01660

c 5.8....................

am No 25, 2010

c 5.10...................

ad F2021L01474

c 5.11...................

ad F2021L01474

Schedule 2A

 

Schedule 2A..............

ad No 25, 2010

 

am F2019L01660

c 1.1....................

ad No 25, 2010

c 1.2....................

ad No 25, 2010

c 1.3....................

ad No 25, 2010

 

am No 188, 2015; F2019L01660

c 1.4....................

ad No 25, 2010

c 1.5....................

ad No 25, 2010

c 1.6....................

ad No 25, 2010

c 1.7....................

ad No 25, 2010

c 1.8....................

ad No 25, 2010

Schedule 3

 

Part 1

 

c 1.1....................

am No 25, 2010; F2018L00311; F2019L01660

c 1.3....................

am F2018L00311

c 1.4....................

am No 25, 2010; F2017L00853; F2018L00311; F2020L00946

c 1.5....................

am F2018L00311

c 1.6....................

am No 25, 2010; F2018L00311; F2019L01660

c 1.8....................

am F2018L00311; F2019L01660

c 1.9....................

am No 25, 2015; F2018L00311; F2019L01660

Part 2

 

c 2.1....................

am F2018L00311

c 2.3....................

am No 25, 2010; F2018L00311

c 2.4....................

am F2018L00311

c 2.5....................

am F2018L00311

Part 3

 

c 3.1....................

am F2018L00311

c 3.3....................

am F2018L00311

c 3.4....................

am F2017L00853; F2018L00311; F2020L00946

c 3.5....................

am F2018L00311; F2019L01660

c 3.6....................

am F2018L00311; F2019L01660

Part 4

 

c 4.1....................

am F2018L00311

c 4.3....................

am F2018L00311

c 4.4....................

am F2017L00853; F2018L00311; F2020L00946

c 4.5....................

am F2018L00311

c 4.7....................

am No 25, 2010; No 188, 2015; F2018L00311; F2019L01660

c 4.8....................

am No 25, 2010; No 188, 2015; F2018L00311; F2019L01660

Part 5

 

c 5.1....................

am F2018L00311

c 5.3....................

am F2018L00311

c 5.4....................

am F2017L00853; F2018L00311; F2020L00946

c 5.5....................

am F2018L00311

c 5.7....................

am F2018L00311; F2019L01660

c 5.8....................

am F2018L00311

Part 6

 

c 6.5....................

am F2017L00853; F2020L00946

c 6.6....................

am No 25, 2010; F2018L00311; F2019L01660

Part 6A

 

Part 6A heading............

rs No 188, 2015

Part 6A..................

ad No 25, 2010

c 1.1....................

ad No 25, 2010

 

rs and renum No 188, 2015

c 6A.1 (prev c 1.1)

 

c 1.2....................

ad No 25, 2010

 

am No 63, 2014

 

rs and renum No 188, 2015

c 6A.2 (prev c 1.2)..........

am F2018L00311

c 1.3....................

ad No 25, 2010

 

am No 188, 2015

 

renum No 188, 2015

c 6A.3 (prev c 1.3)

 

c 1.4....................

ad No 25, 2010

 

rs and renum No 188, 2015

c 6A.4 (prev c 1.4)

 

Part 6B

 

Part 6B..................

ad No 188, 2015

c 6B.1...................

ad No 188, 2015

 

am F2020L00946

c 6B.2...................

ad No 188, 2015

c 6B.3...................

ad No 188, 2015

c 6B.4...................

ad No 188, 2015

c 6B.5...................

ad No 188, 2015

c 6B.6...................

ad No 188, 2015

 

am F2019L01660

c 6B.7...................

ad No 188, 2015

c 6B.8...................

ad F2020L00946

Part 7

 

c 7.1....................

am F2019L01660

c 7.2....................

am No 25, 2010; F2017L00853; F2019L01660

c 7.5....................

am No 32, 2011; F2017L00853; F2020L00946; F2021L01474

c 7.6....................

am F2019L01660

Schedule 3AA

 

Schedule 3AA.............

ad F2018L00311

c 1.....................

ad F2018L00311

c 2.....................

ad F2018L00311

c 3.....................

ad F2018L00311

 

am F2023L00769

c 4.....................

ad F2018L00311

c 5.....................

ad F2018L00311

 

am F2023L00769

c 6.....................

ad F2018L00311

 

am F2023L00769

c 7.....................

ad F2018L00311

Schedule 3A

 

Schedule 3A..............

ad No 267, 2010

 

am No 104, 2011; F2017L00853; F2018L00311

Schedule 4

 

Schedule 4................

am No 78, 2004; No 270, 2008; No 25, 2010; No 267, 2010; No 90, 2015; No 188, 2015; F2017L00853

 

ed C32

 

am F2018L00311; F2018L00516; F2019L01660; F2020L00946; F2020L01598; F2020L01645; F2021L01032; F2021L00450; F2021L01474; F2021L01809; F2022L01687; F2023L00769; F2023L01558; F2023L01667

Schedule 5

 

Schedule 5................

am No 153, 2003; No 128, 2004; No 193, 2005; No 214, 2006; No 163, 2007; No 119, 2008; No 181, 2009; No 25, 2010; No 132, 2010; No 104, 2011; No 147, 2012; No 94, 2013; No 62, 2014; No 87, 2015; No 188, 2015; F2016L00667; F2017L00552; F2017L00853; F2017L01561; F2018L00311; F2018L00759; F2018L01434; F2019L00396; F2019L01660; F2020L00720; F2021L00688; F2021L01474

 

ed C52

 

am F2022L00600; F2023L00770

Dictionary

 

Dictionary................

am No 25, 2010; No 267, 2010; No 196, 2014; No 46, 2015; No 188, 2015; F2016L00109; F2017L00853; F2017L01561; F2017L01692; F2018L00311

 

ed C40

 

am F2019L01660; F2020L00946; F2021L01474; F2022L00243; F2022L01687; F2023L01667

 


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