Therapeutic Goods (Medical Devices—Specified Articles) Instrument 2020
This Instrument specifies certain classes of articles that are considered medical devices for the purposes of the Therapeutic Goods Act 1989.
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Official version of legislation
The Federal Register of Legislation is the authorised Australian Government website for Commonwealth legislation. It contains the full text and details of the life cycle of individual laws.
Guidance referring to this legislation
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GuidanceGuidance for manufacturers and sponsors of personalised medical devices, including health professionals. Learn what we mean by ‘specified articles’ and the difference between exempt vs excluded products.
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GuidanceGuidance to help sponsors figure out if their therapeutic goods are medicines, biologicals, or medical devices.
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GuidanceInformation to assist sponsors and manufacturers of products making antiviral claims determine if their product require an entry in the Australian Register of Therapeutic Goods (ARTG) to be legally imported and/or supplied in Australia.