Commonwealth Consolidated Regulations Commonwealth Consolidated RegulationsStatutory Rules No. 236, 2002
made under the
Compilation No. 65
Compilation date: 14 October 2024
Includes amendments: F2024L01299
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 14 October 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If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.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
11.23 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
Division 11.20--Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024
11.74 Definitions
11.75 Exemption for certain prescription spectacle lenses
11.76 Auditing of applications
11.77 Reclassification of medical devices
Division 11.21--Application provisions relating to the Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2024
11.78 Application provision--application audit assessment fees
Division 11.22--Application provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024
11.79 Definitions
11.80 Application of amendments
11.81 Transitional vaping devices--exemption from Division 3 of Part 4-11 of the Act
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 their derivatives
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
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.
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) |
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 | -- |
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) | -- |
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) | -- |
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) | -- |
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) | -- |
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) | -- |
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) | -- |
Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024 | 14 June 2024 (F2024L00686) | Sch 1 (items 5-7, 17): 15 June 2024 (s 2(1) item 2) | -- |
Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2024 | 17 June 2024 (F2024L00689) | Sch 1 (items 1-14): 1 July 2024 (s 2(1) item 2) | -- |
Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024 | 28 June 2024 (F2024L00839) | Sch 1 (items 1-15, 33, 34): 1 July 2024 (s 2(1) item 2) | -- |
Administrative Review Tribunal Legislation Consequential Amendments (2024 Measures No. 1) Regulations 2024 | 11 Oct 2024 (F2024L01299) | Sch 7 (items 21-27): 14 Oct 2024 (s 2(1) item 1) | -- |
Act | Number and year | Assent | Commencement | Application, saving and transitional provisions | |
Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 | 50, 2024 | 27 June 2024 | Sch 4 (items 5, 18): 1 Oct 2024 (s 2(1) item 5) | Sch 4 (item 18) | |
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; F2024L00686 |
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; F2024L00686 |
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; F2024L00689 |
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 No 153, 2003 |
| am No 267, 2010; No 188, 2015; F2024L00689 |
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 10.6................... | am F2024L00839 |
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; F2024L01299 |
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 |
| rep F2024L00686 |
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; F2024L00686 |
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 |
| am F2024L00839 |
Division 11.20 |
|
Division 11.20............. | ad F2024L00686 |
r 11.74.................. | ad F2024L00686 |
| am F2024L00686 |
r 11.75.................. | ad F2024L00686 |
r 11.76.................. | ad F2024L00686 |
r 11.77 (first occurring)....... | ad F2024L00686 |
Division 11.21 |
|
Division 11.21............. | ad F2024L00689 |
r 11.77 (second occurring)..... | ad F2024L00689 |
| renum |
| ed C63 |
r 11.78 (prev r 11.77 second |
|
Division 11.22 |
|
Division 11.22............. | ad F2024L00839 |
r 11.79.................. | ad F2024L00839 |
r 11.80.................. | ad F2024L00839 |
r 11.81.................. | ad F2024L00839 |
| (2) exp end of 31 Dec 2024 (r 11.81(3)) |
Schedule 1 |
|
Schedule 1................ | am No 259, 2003; No 25, 2010; F2016L00109 |
| ed C33 |
| am F2017L01692 |
| ed C39 |
| am F2019L01660; F2021L01474; F2021L01809; F2022L00243; F2022L01687; F2024L00686 |
| |
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 5.5.................... | rs F2024L00686 |
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; F2024L00686; F2024L00689; F2024L00839; Act No 50, 2024 |
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; F2024L00689 |
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; F2024L00839 |