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Medical devices/IVDs

12 January 2022
Update to post-market review of rapid-antigen test including third party testing details
21 December 2021

In Australia, at present, the most widely used COVID-19 diagnostic tests are SARS-CoV-2 nucleic acid tests (NATs), which detect a range of different gene targets within the SARS-CoV-2 genome.

As NATs directly target the viral genome, they may be particularly vulnerable to sequence...

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.
22 November 2021
Updated guidance to reflect new amendments made to the regulations.
29 October 2021
Conditions which placed limitations on the supply of a HIV self-test changed on 22 October 2021 to improve the accessibility of HIV testing.
19 October 2021
Stakeholders are invited to review the discussion paper and provide their feedback using the online survey. Closing date: 13 December 2021
18 October 2021
The public consultation for the Proposed refinements to the requirements for medical device patient information materials.
25 January 2022
A list of self-tests that are approved in Australia


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