You are here

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.

1 November 2021

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

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

14 October 2021

Find information about advertising COVID-19 rapid tests.

28 September 2021

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

22 September 2021
The TGA has issued two infringement notices totalling $26,640 to Tianda Pharmaceuticals Australia Pty Ltd for alleged unlawful advertising of a listed medicine in relation to COVID-19.
20 September 2021
Answers to frequently asked questions in relation to rapid antigen tests.
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 August 2021
Where suitable, TGA inspectors will undertake remote and/or hybrid Good Manufacturing Practice (GMP) domestic inspections during the COVID-19 pandemic.
18 August 2021
An overview of the regulation of Personal Protective Equipment (PPE) in Australia, including face masks, gowns and gloves.

Pages

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.

Follow us