Scope: |
This ESSENTIAL describes the regulatory requirements of medical devices in Australia, based on the
- Therapeutic Goods Act 1989
- Therapeutic Goods (Medical Devices) Regulations 2002
- Information provided by the Therapeutic Goods Administration (TGA)
Health products are classified into four risk classes, according to the risk associated with their use.
Class I
Class IIa
Class IIb
Class III
Not in scope of this CRF:
- In-Vitro Diagnostics (see: ESSENTIAL AUS In-Vitro Diagnostics)
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Legislation in force: |
Content:
Chapter 1 - Preliminary
Chapter 2 - Australian Register of Therapeutic Goods
Chapter 2A - Prohibition on import, export, manufacture or supply of therapeutic goods—international agreements
Chapter 3 - Medicines and other therapeutic goods that are not medical devices
Chapter 4 - Medical devices
Chapter 5 - Advertising, counterfeit therapeutic goods and product tampering
Chapter 6 - Administration
Chapter 7 - Miscellaneous
Chapter 8 - Repeal and transitional provisions
A medical device is defined as:
any instrument, apparatus, appliance, software, implant, reagent, material or other article (whether used alone or in combination, and including the software necessary for its proper application) intended, by the person under whose name it is or is to be supplied, to be used for human beings. (Section 41BD)
Content:
Part 1 - Preliminary
Part 2 - Essential principles
Part 3 - Conformity assessment procedures
Division 3.1 - Medical device classifications
Division 3.2 - Conformity assessment procedures
Part 4 - Conformity assessment certificates
Part 5 - Including medical devices in the Register
Part 6 - Suspension and cancellation from the Register
Part 7 - Exempting medical devices from inclusion in the Register
Part 8 - Obtaining information
Part 9 - Fees
Part 10 - Miscellaneous
Part 11 - Transitional provisions
Schedule 1 - Essential principles
Schedule 2 - Classification rules for medical devices other than IVD medical devices
Schedule 3 - Conformity assessment procedures
Schedule 4 - Exempt devices
Schedule 5 - Fees
The Therapeutic Goods Determination lists the documents to be provided at the application for registration of medical devices in Australia.
Content:
Schedule 1—Medical devices other than IVD medical devices
Part 1—Class I medical devices
Part 2—Class IIa medical devices
Part 3—Class IIb medical devices
Part 4—Class III medical devices
Part 5—Class AIMD medical devices
Schedule 2—IVD medical devices
Schedule 2A—Medical devices intended for export only
Schedule 3—Medical devices used for a special purpose that are a system or procedure pack
Endnotes
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Comment on the comparability to EU legislation: |
An alignment between the legislation of Australia and the European Union has been proposed.... |