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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.

30 November 2020
A list of tests approved for inclusion in the Australian Register of Therapeutic Goods (ARTG)
26 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.
23 November 2020
In response to the COVID-19 pandemic, the TGA has expedited approvals for inclusion of COVID-19 tests in the Australian Register of Therapeutic Goods (ARTG). The TGA has commenced validation reviews of serology-based COVID-19 point-of-care tests included in the ARTG.
20 November 2020
A list of ventilators that meet minimum requirements and are permitted to be supplied under the COVID-19 Emergency Exemption.
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

5 November 2020

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

19 October 2020
The Doherty Institute has completed its validation of fifteen serology-based point of care tests as part of a TGA post market review. The TGA has requested the sponsors of these devices to provide further information on the clinical studies undertaken by the manufacturer to support the performance...
12 October 2020
Information for sponsors regarding the supply of COVID-19 tests, including advice for those sponsors new to therapeutic goods regulation in Australia
9 October 2020
An overview of the regulation of Personal Protective Equipment (PPE) in Australia, including face masks, gowns and gloves.

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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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