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Coronavirus (COVID-19): Information on medicines and medical devices

The TGA is publishing the latest information about medicines and medical devices as it relates to COVID-19 on this page.

Please read the information below before contacting the TGA to see if your question is already answered.

25 October 2021
A list of tests approved for inclusion in the Australian Register of Therapeutic Goods (ARTG)
21 October 2021

COVID-19 vaccines undergoing evaluation for provisional registration by the TGA

19 October 2021

COVID-19 vaccine batch release information is now available.

14 October 2021

This is current advice relating to the supply of in vitro diagnostic medical devices for the detection of COVID-19/SARS-CoV-2 infections

14 October 2021
Update to TGA's conditions and advertising requirements for COVID-19 rapid point-of-care tests.
13 October 2021
The TGA has granted a number of provisional determinations in relation to COVID-19 vaccines.
28 September 2021

Updated to reflect changes to allow self-testing and updated conditions.

20 September 2021
Answers to frequently asked questions in relation to rapid antigen tests.
8 September 2021
The TGA is undertaking a post-market review of all Point of Care and Laboratory tests included in the ARTG, which are intended to identify patients with COVID-19, to ensure they can detect the emerging SARS-CoV-2 genetic variants and remain accurate.
7 September 2021

Guidance and checklist for businesses to understand the requirements for safe implementation of COVID-19 rapid antigen point-of-care testing.

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Further information

Contact TGA Info

Tel: 1800 020 653
Email: info@tga.gov.au

Note: we are currently experiencing a high volume of calls and emails. Please bear with us as we try to respond to queries as quickly as possible.

Department of Health

Coronavirus (COVID-19) health alert — for information and advice not specific to therapeutic goods.

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