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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.

7 July 2022
A list of tests approved for inclusion in the Australian Register of Therapeutic Goods (ARTG)
29 June 2022

A list of self-tests that are approved in Australia

22 June 2022
The TGA has issued eight (8) infringement notices totalling $106,560 to Hough Pharma Pty Ltd for allegedly failing to provide information to the TGA to demonstrate the safety and performance of three COVID-19 RATs.
27 May 2022

Find information about the supply of COVID-19 rapid antigen self-tests to assist sponsors, manufacturers and consumers. Also includes information about the detection of multiple respiratory targets such as influenza A, influenza B and COVID-19 in a single rapid antigen test format (Combination...

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.

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

Find information about advertising COVID-19 rapid tests.

24 January 2022

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

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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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