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regulatory guidance

26 November 2021
This guidance applies to manufacturers of medical devices that are regulated as 'system or procedure packs' and supplied using the special conformity assessment procedure regulatory pathway.
18 January 2022
Updated guidance: the Advertising Code and naming therapeutic goods
22 November 2021
Updated guidance to reflect new amendments made to the regulations.
11 October 2021
Guidance to assist manufacturers of active medical devices, including software-based medical devices, in correctly classifying their devices
29 March 2022
Updated guidance to reflect new amendments made to the regulations.
22 November 2021
Updated guidance to reflect new amendments made to the regulations.
17 September 2021
The conformity assessment certification and audit requirements for certain medical devices have changed.
13 September 2021
Guidance for advertising - claims such as 'TGA approved' must not be used in advertisements for therapeutic goods
1 September 2021
Answers to frequently asked questions about off-label use of medical devices.
3 March 2022
Information about advertising COVID-19 rapid tests.

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