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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.

11 August 2022
A list of tests approved for inclusion in the Australian Register of Therapeutic Goods (ARTG)
9 August 2022
The TGA is undertaking a post-market review of face masks included in the ARTG. This page lists all face masks that have been cancelled from the ARTG during the review.
8 August 2022

A list of self-tests that are approved in Australia

22 July 2022
A list of disinfectant products included in the ARTG with specific claims against SARS-Cov-2 (COVID 19) or COVID-19 on the product label.
7 July 2022
For sponsors and manufacturers wishing to make label claims of efficacy against COVID-19 for products that are either hard surface disinfectants or disinfectants that are medical devices
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...

16 May 2022
The TGA is undertaking a post-market review of all face masks included in the Australian Register of Therapeutic Goods to ensure the quality and effectiveness of face masks.
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

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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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