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.

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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.

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

Official version of legislation

Guidance referring to this legislation

Understanding rules for boundary and combination products

Supplying biologicals packaged or combined with other therapeutic goods

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

Official version of legislation

Guidance referring to this legislation

Understanding rules for boundary and combination products

Supplying biologicals packaged or combined with other therapeutic goods

Help us improve this page