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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.

24 February 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.
8 February 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.
5 February 2021
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.
5 February 2021
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...
3 February 2021
Information about a TGA post-market review of face masks, including guidance for suppliers and users of face masks.
31 January 2021
A list of ventilators that meet minimum requirements and are permitted to be supplied under the COVID-19 Emergency Exemption.
31 January 2021
To assist healthcare facilities, the TGA has provided guidance to assist with sourcing additional equipment to treat patients in the event of a shortage of ventilators and other respiratory support devices.
31 January 2021
What you need to know before you seek to import personal protective equipment (PPE) into Australia during the COVID-19 pandemic.
28 January 2021
Information relating to face masks and gowns to assist healthcare organisations as they update their operating procedures during the outbreak
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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