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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.

23 November 2020
The TGA is undertaking a post-market review of face masks included in the ARTG. This page lists all face masks that have been cancelled from the ARTG during the review.
14 November 2020
Information about a TGA post-market review of face masks, including guidance for suppliers and users of face masks.
6 November 2020

Action in relation to non-compliant face masks will be published on the TGA web site

9 October 2020
An overview of the regulation of Personal Protective Equipment (PPE) in Australia, including face masks, gowns and gloves.
17 September 2020
Information relating to face masks and gowns to assist healthcare organisations as they update their operating procedures during the outbreak
19 August 2020
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).
30 July 2020
Guidance to assist manufacturers of medical devices and their component parts with meeting their regulatory obligations.
21 May 2020
Information to help ensure individuals and organisations clearly understand and minimise the risks of reusing face masks and gowns.

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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