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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.

6 May 2022

A list of self-tests that are approved in Australia

17 March 2022

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.

3 March 2022

Find information about advertising COVID-19 rapid tests.

3 March 2022

Find information about the supply of COVID-19 rapid antigen self-tests to assist sponsors, manufacturers and consumers.

14 February 2022
Update to confirmatory testing and reporting requirements
8 February 2022

Find information about advertising COVID-19 rapid tests.

17 January 2022
Updated guidance for businesses using rapid antigen tests approved by the TGA as point-of-care tests
14 January 2022
Important information about the use of COVID-19 point-of-care tests.
12 January 2022
Answers to frequently asked questions in relation to rapid antigen tests.
7 April 2021

Information about the post-market review of all approved COVID-19 tests and a post-market evaluation of all approved serology-based COVID point-of-care tests.

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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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