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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.

22 October 2021
The TGA is undertaking a post-market review of all face masks included in the Australian Register of Therapeutic Goods to ensure the quality and effectiveness of face masks.
30 September 2021
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.
20 September 2021
Answers to frequently asked questions in relation to rapid antigen tests.
8 September 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.
8 September 2021

This page compiles all of our resources related to face masks and COVID-19.

18 August 2021
Information about a TGA post-market review of face masks, including guidance for suppliers and users of face masks.
9 June 2021

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

31 January 2021
What you need to know before you seek to import personal protective equipment (PPE) into Australia during the COVID-19 pandemic.
29 January 2021
Two emergency exemptions that were made to facilitate the supply of ventilators and personal protective equipment in Australia during the COVID-19 emergency will cease on 31 January 2021.
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).

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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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