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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.

17 September 2021
A list of tests approved for inclusion in the Australian Register of Therapeutic Goods (ARTG)
16 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.
10 September 2021

Guidance for sponsors and manufacturers in preparing COVID-19 rapid antigen self-test applications

10 September 2021
General information about rapid antigen point-of-care testing in Australia
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.
7 September 2021

Guidance and checklist for businesses to understand the requirements for safe implementation of COVID-19 rapid antigen point-of-care testing.

7 September 2021
Answers to frequently asked questions in relation to rapid antigen tests.
6 September 2021
TGA is progressing work that would allow the provision of self-tests for COVID-19 in the future.
25 August 2021

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

25 August 2021
COVID-19 tests must be done under the direction of a health professional. The advertising and sale of home tests is prohibited.

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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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