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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.

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COVID-19 rapid antigen self-tests that are approved in Australia

29 June 2022

A list of self-tests that are approved in Australia

Disinfectants for use against COVID-19 in the ARTG for legal supply in Australia

27 June 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.

Hough Pharma Pty Ltd fined $106,560 for allegedly failing to provide information to demonstrate adequate performance of three COVID-19 rapid antigen tests and for allegedly failing to provide appropriate customer support

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.

Post-market review of face masks: Cancelled ARTG entries

3 June 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.

Post-market review of face masks: Outcomes and actions

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.

Post-market review of nucleic acid tests

17 March 2022

The ability of COVID-19 tests to detect emerging genetic variants of SARS-CoV-2

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.

COVID-19 serology point-of-care tests

14 January 2022
Important information about the use of COVID-19 point-of-care tests.

COVID-19 testing in Australia - information for health professionals

12 January 2022

Find out information about the different types of tests and how the TGA assesses them and monitors their performance.

Q&As - Conditions of supply for rapid antigen point of care COVID-19 tests

12 January 2022
Answers to frequently asked questions in relation to rapid antigen 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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