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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.

14 October 2021

This is current advice relating to the supply of in vitro diagnostic medical devices for the detection of COVID-19/SARS-CoV-2 infections

28 September 2021

Updated to reflect changes to allow self-testing and updated conditions.

7 September 2021

Guidance and checklist for businesses to understand the requirements for safe implementation of COVID-19 rapid antigen point-of-care testing.

25 August 2021
Information for sponsors regarding the supply of COVID-19 tests, including advice for those sponsors new to therapeutic goods regulation in Australia.
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.
3 August 2020
Information on advertising of products related to COVID-19, GMP information for sponsors and manufacturers and access to coronavirus tests, medicines and vaccines, including medicine shortages
1 July 2020
Pharmacies can return children's paracetamol liquid formulations to front-of-counter, but the one unit limit on sales remains in place.
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.

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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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