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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.

21 October 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.
21 October 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 October 2020
A list of tests approved for inclusion in the Australian Register of Therapeutic Goods (ARTG)
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...
14 October 2020
The TGA has granted a provisional determination to Pfizer Australia Pty Ltd in relation to its COVID-19 Vaccine, BNT162b2 [mRNA].
14 October 2020
A list of disinfectant products included in the ARTG with specific claims against SARS-Cov-2 (COVID 19) or COVID-19 on the product label.
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
The TGA has granted a provisional determination to AstraZeneca Pty Ltd in relation to its COVID-19 Vaccine, ChAd0x1-S [recombinant].
9 October 2020
An overview of the regulation of Personal Protective Equipment (PPE) in Australia, including face masks, gowns and gloves.
8 October 2020
How we test for COVID-19 in Australia

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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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