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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.

10 September 2021
General information about rapid antigen point-of-care testing in Australia
8 September 2021
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.
7 September 2021
Answers to frequently asked questions in relation to rapid antigen tests.
25 August 2021
How we test for COVID-19 in Australia
25 August 2021
COVID-19 tests must be done under the direction of a health professional. The advertising and sale of home tests is prohibited.
7 May 2020
The TGA has issued an infringement notice for $2,520 to a woman in Western Australia for alleged breaches relating to COVID-19 test kits.
7 May 2020
The TGA has issued five infringement notices totalling $63,000 to a Queensland company for alleged breaches relating to COVID-19 test kits.
24 April 2020
The TGA has issued an infringement notice for $2,520 to a woman in Western Australia for alleged breaches relating to COVID-19 test kits.
24 April 2020
The TGA has issued an infringement notice for $12,600 to Labtest Direct for the alleged advertising of COVID-19 Rapid Test kits.
24 April 2020
The TGA has issued infringement notices totalling $25,200 to Queensland company CK Surgitech for alleged breaches relating to COVID-19 test kits.

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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