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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.

20 September 2021
Answers to frequently asked questions in relation to rapid antigen tests.
7 September 2021

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

25 August 2021

Find out information about the different types of tests and how the TGA assesses them and monitors their performance.

25 August 2021
Information for sponsors regarding the supply of COVID-19 tests, including advice for those sponsors new to therapeutic goods regulation in Australia.
24 March 2021

Information about the post-market review of all approved COVID-19 tests and a post-market evaluation of all approved serology-based COVID point-of-care tests.

11 March 2021
In response to the COVID-19 pandemic, the TGA has expedited the approval (with conditions) of COVID-19 tests including tests intended for laboratory use and those intended for use by specified health professionals at the point of care.
18 December 2020
The TGA has issued three infringement notices totalling $7,992 to a Sydney man for the alleged unlawful advertising of a disinfectant and a hand sanitiser in relation to COVID-19.
17 December 2020
The TGA has issued four infringement notices totalling $10,656 to a West Australian man, for alleged unlawful advertising of cannabidiol (CBD).
30 September 2020
The TGA has issued an infringement notice totalling $13,320 to Sydney-based company Hepworth Industrial Wear for the alleged unlawful importation of surgical face masks in relation to COVID-19.
3 September 2020
The TGA has initiated proceedings in the Federal Court of Australia in response to alleged unlawful advertising of hyperbaric oxygen therapy chambers by Oxymed Australia and its sole director, Mr Malcolm Hooper.

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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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