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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.

28 January 2021
Guidance to help determine when a face mask is a medical device and therefore must be included in the Australian Register of Therapeutic Goods (ARTG).
13 January 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.
4 December 2020
Information for sponsors regarding the supply of COVID-19 tests, including advice for those sponsors new to therapeutic goods regulation in Australia
2 October 2020

All applications in relation to COVID-19 are being expedited as a matter of priority (separate to the Priority Review pathway)

31 August 2020
Information for consumers about buying and using hand sanitisers.
26 August 2020
Important information about the use of COVID-19 point-of-care tests.
26 August 2020
We have identified disinfectants as being critical in preventing the spread of COVID-19. This information provides advice on how to use disinfectants properly
26 August 2020
There is significant interest from potential sponsors and manufacturers to understand how disinfectants are regulated and how to supply them
26 August 2020
Frequently asked questions for new sponsors in relation to the supply of disinfectant products.
26 August 2020
Guidance for new sponsors in relation to the supply, import, and export of disinfectant products.

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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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