Therapeutic Goods (Articles that are Not Medical Devices) Declaration 2023

This Determination specifies a number of articles that are not medical devices for the purposes of the Therapeutic Goods Act 1989.

Official version of legislation
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Guidance referring to this legislation

Understanding rules for boundary and combination products

20 November 2024

Guidance

Guidance to help sponsors figure out if their therapeutic goods are medicines, biologicals, or medical devices.
Supplying biologicals packaged or combined with other therapeutic goods

1 October 2024

Guidance

Guidance about how we regulate biologicals that are packaged, or combined, with other therapeutic goods.