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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 January 2022

A list of self-tests that are approved in Australia

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

24 January 2022
Information for sponsors regarding the supply of COVID-19 tests, including advice for those sponsors new to therapeutic goods regulation in Australia.
21 January 2022
A list of tests approved for inclusion in the Australian Register of Therapeutic Goods (ARTG)
17 January 2022
Updated guidance for businesses using rapid antigen tests approved by the TGA as point-of-care tests
17 January 2022

Find out about the different ways we test for COVID-19 in Australia.

14 January 2022
Important information about the use of COVID-19 point-of-care tests.
14 January 2022
The TGA has issued an infringement notice, totalling $26,640, to Ezy Company Pty Ltd for alleged unlawful importation of COVID-19 rapid antigen tests and nicotine vaping products.
12 January 2022

Find information about advertising COVID-19 rapid tests.

12 January 2022

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

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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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