Australia Medical Device Regulations


All documents listed below are available from the Australian Therapeutic Goods Administration (TGA) website. Please help us maintain this list by reporting outdated or missing documents. If you need help determining the regulatory requirements for your medical device in Australia, you may be interested in our custom regulatory strategy reports for Australia.

Please note that this information is copyrighted by the TGA. You may download, store in cache, display, print and copy a single copy or part of a single copy of information or material from this site only for your personal, non-commercial use and only in an unaltered form.

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Major Regulations

*The Major Regulations affecting medical devices and IVDs are available from the Australian Government Attorney General's office.

General Guidance Documents

Specific Guidance Documents

Forms and Applications

Additional Information

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