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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.

7 September 2021

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

24 August 2021
Where suitable, TGA inspectors will undertake remote and/or hybrid Good Manufacturing Practice (GMP) domestic inspections during the COVID-19 pandemic.
18 August 2021
An overview of the regulation of Personal Protective Equipment (PPE) in Australia, including face masks, gowns and gloves.
18 August 2021
Information about a TGA post-market review of face masks, including guidance for suppliers and users of face masks.
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.

12 March 2021
In response to the COVID-19 pandemic, the TGA has received a significant number of thermometer applications. This guidance assists thermometer sponsors and manufacturers to meet their regulatory obligations.
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.
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
Information for sponsors and manufacturers about pathways for exporting a ventilator from Australia.
31 January 2021
The TGA has established an expedited recall pathway for faulty or unauthorised COVID-19 devices

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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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