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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.

13 August 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.
13 August 2020
The Doherty Institute has completed its validation of eight 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 of...
13 August 2020

Report any non-compliant advertisements for therapeutic goods

13 August 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.
13 August 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.
13 August 2020
An overview of the regulation of Personal Protective Equipment (PPE) in Australia, including face masks, gowns and gloves.
13 August 2020
Information about a TGA post-market review of face masks, including guidance for suppliers and users of face masks.
13 August 2020
Information relating to surgical masks and gowns to assist healthcare organisations as they update their operating procedures during the outbreak
13 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).
12 August 2020
An exemption from some pre-market regulatory requirements is now in place for domestically manufactured invasive ventilators that meet certain specifications and testing requirements published in Ventilator for COVID-19 use 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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