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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.

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

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.
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.
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
Answers to frequently asked questions in relation to rapid antigen tests.
17 December 2021
Information about a TGA post-market review of face masks, including guidance for suppliers and users of face masks.
9 December 2021
An overview of the regulation of Personal Protective Equipment (PPE) in Australia, including face masks, gowns and gloves.

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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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