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Therapeutic Goods (Medical Devices) Regulations 2002

In force Administered by
- Department of Health, Disability and Ageing
This item is authorised by the following title:

• Therapeutic Goods Act 1989 Latest version View as made version F2026C00240 C70 21 March 2026 This instrument was backcaptured in accordance with Section 36 of the Legislative Instruments Act 2003

View document Legislative instrument Filter active Table of 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 8AA—Mandatory reporting of adverse events by healthcare facilities
- 8AA.1 Healthcare facilities
- 8AA.2 Reportable medical devices
- 8AA.3 Report requirements
- 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 9A—Australian Unique Device Identification Database
- 9A.1 Australian Unique Device Identification Database
- 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
- Division 11.23—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024
- 11.82 Definitions
- 11.83 Exempt therapeutic goods
- 11.84 Notices, statements and determinations
- Division 11.24—Application provisions relating to the Therapeutic Goods Legislation Amendment (Australian Unique Device Identification Database and Other Measures) Regulations 2025
- 11.85 Application provisions—Australian Unique Device Identification Database
- Division 11.25—Application provisions relating to the Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2025
- 11.86 Exempt therapeutic goods
- 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—Other principles
- 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
- 13.5 UDI medical devices—UDI device identifier and UDI production identifier
- 13.6 UDI medical devices—medical device packaging identifier
- 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
- 13C Rules for UDI medical devices
- 13C.1 Identifiers relating to UDI medical devices
- 13C.2 Inclusion of identifiers in the Australian Unique Device Identification Database
- 13C.3 Inclusion of other information in the Australian Unique Device Identification Database
- 13C.4 Information in the Australian Unique Device Identification Database to be accurate and up to date
- 13C.5 UDI device identifier and UDI production identifier to be directly marked on UDI medical device
- 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