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regulatory guidance

24 January 2022
The Therapeutic Goods Advertising Code (the Code) is the cornerstone of the therapeutic goods advertising regulatory framework.
24 January 2022
The 2021 Advertising Code took effect on 1 January 2022 and will be subject to a 6-month transition period until 30 June 2022 where both the 2018 and 2021 Advertising Codes will apply.
17 December 2021
New features added to the consent application form on TBS portal.
26 November 2021
New guidance on the regulation of system or procedure packs and using the special conformity assessment procedure.
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
22 November 2021
Updated guidance to reflect new amendments made to the regulations.
22 November 2021
Updated guidance to reflect new amendments made to the regulations.

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