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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.

17 August 2022

A list of self-tests that are approved in Australia

10 August 2022
The Federal Court of Australia has ordered Enviro Tech Holdings Pty Ltd to pay $80,000 for unlawful importation of surgical face masks.
10 August 2022
The TGA has issued five infringement notices totalling $66,600 to 2San Pty Ltd for allegedly failing to provide information to the TGA to demonstrate the ongoing minimum level of sensitivity of two COVID-19 rapid antigen tests (RATs).
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.
3 June 2022
The TGA has issued one infringement notice totalling $2,664 to a Queensland based individual for alleged unlawful advertising of therapeutic goods in relation to COVID-19.
3 June 2022
The TGA has issued four infringement notices totalling $10,664 to an individual for alleged unlawful importation of COVID-19 rapid antigen tests (RATs).
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...

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.

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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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