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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.

24 November 2021

A list of self-tests that are approved in Australia

8 November 2021
Information for advertisers and consumers relating to ads for therapeutic goods that claim to treat or prevent COVID-19, including specific advertising requirements and consequences for non-compliance
3 November 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.
1 November 2021

Find information about the supply of COVID-19 rapid antigen self-tests to assist sponsors, manufacturers and consumers.

15 October 2021

Find out about the different ways we test for COVID-19 in Australia.

20 September 2021
Answers to frequently asked questions in relation to rapid antigen tests.
25 August 2021

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

24 March 2021

Information about the post-market review of all approved COVID-19 tests and a post-market evaluation of all approved serology-based COVID point-of-care tests.

11 March 2021
In response to the COVID-19 pandemic, the TGA has expedited the approval (with conditions) of COVID-19 tests including tests intended for laboratory use and those intended for use by specified health professionals at the point of care.
30 September 2020
The TGA has issued an infringement notice totalling $13,320 to Sydney-based company Hepworth Industrial Wear for the alleged unlawful importation of surgical face masks in relation to COVID-19.

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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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