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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.
Filters
Topics and product types
I want to
- Supply a COVID-19 test kit (6) Apply Supply a COVID-19 test kit filter
- Remove Supply a face mask, gloves or gown filter Supply a face mask, gloves or gown (2)
Audience
- Health professionals (1) Apply Health professionals filter
- Remove Manufacturers filter Manufacturers (1)
- Remove Sponsors filter Sponsors (2)
Filters applied:
- (-) Remove Sponsors filter Sponsors
- (-) Remove Manufacturers filter Manufacturers
- (-) Remove Supply a face mask, gloves or gown filter Supply a face mask, gloves or gown
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.
28 January 2021
If you are considering supplying face masks (including respirators) that meet the definition of a medical device in Australia, you will need to apply for the inclusion of these products in the ARTG.
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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