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Medical devices/IVDs

23 February 2022
The TGA sought feedback on a Discussion paper on potential changes to mandatory reporting of medical device adverse events.
18 October 2021
The public consultation for the Proposed refinements to the requirements for medical device patient information materials.
6 May 2022
A list of approved COVID-19 tests included in the ARTG for supply in Australia
27 January 2022
New information about importing self-tests
11 February 2022
Inclusion of links to the requirements for importing and exporting COVID-19 rapid antigen test kits for commercial and personal use.
12 January 2022
The conditions for inclusion of COVID-19 point-of-care tests have been clarified
11 October 2021
Guidance to assist manufacturers of active medical devices, including software-based medical devices, in correctly classifying their devices
3 March 2022
Update on collecting saliva for rapid antigen self-tests.
1 February 2022

Find out about rapid antigen tests in Australia, including self-tests.

6 October 2021
GMDN guidance is to assist sponsors and manufacturers when applying for inclusion in the ARTG and selecting a GMDN term.


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