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The Therapeutic Goods Advertising Code

24 January 2022
The Therapeutic Goods Advertising Code (the Code) is the cornerstone of the therapeutic goods advertising regulatory framework.

Guidance on applying the Advertising Code rules

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.

Guidance for consent application form on the TGA Business Services (TBS) portal

17 December 2021
New features added to the consent application form on TBS portal.

System or procedure packs

26 November 2021
New guidance on the regulation of system or procedure packs and using the special conformity assessment procedure.

Guidance for manufacturer's declaration of conformity for system or procedure packs

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.

The Advertising Code and naming therapeutic goods

18 January 2022
Updated guidance: the Advertising Code and naming therapeutic goods

Reclassification of medical devices that are substances introduced into the human body via a body orifice or applied to the skin

22 November 2021
Updated guidance to reflect new amendments made to the regulations.

Classification of active medical devices (including software-based medical devices)

11 October 2021
Guidance to assist manufacturers of active medical devices, including software-based medical devices, in correctly classifying their devices

Reclassification of spinal implantable medical devices

22 November 2021
Updated guidance to reflect new amendments made to the regulations.

Reclassification of medical devices in direct contact with the heart, central circulatory and central nervous systems

22 November 2021
Updated guidance to reflect new amendments made to the regulations.

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