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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.
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17 December 2021
Information about a TGA post-market review of face masks, including guidance for suppliers and users of face masks.
9 December 2021
An overview of the regulation of Personal Protective Equipment (PPE) in Australia, including face masks, gowns and gloves.
5 November 2021
Action in relation to non-compliant face masks will be published on the TGA web site
8 September 2021
This page compiles all of our resources related to face masks and COVID-19.
10 August 2021
Guidance to assist manufacturers in choosing appropriate standards and to set out the TGA's expectations for performance testing of respirators, surgical respirators and medical/surgical facemasks, before inclusion on the ARTG.
7 April 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.
Regulation of thermometers and other temperature measuring medical devices and products for COVID-19
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.
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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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