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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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31 August 2020
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.
28 August 2020
The TGA has issued three infringement notices for $39,960 to Melbourne-based company Yarra Valley Cleaning Co for the alleged unlawful advertising of a disinfectant product in relation to COVID-19.
26 August 2020
Important information about the use of COVID-19 point-of-care tests.
26 August 2020
There is significant interest from potential sponsors and manufacturers to understand how disinfectants are regulated and how to supply them
26 August 2020
Frequently asked questions for new sponsors in relation to the supply of disinfectant products.
26 August 2020
Guidance for new sponsors in relation to the supply, import, and export of disinfectant products.
26 August 2020
An exemption from some pre-market regulatory requirements is now in place for domestically manufactured invasive ventilators that meet certain specifications and testing requirements published in Ventilator for COVID-19 use in Australia.
26 August 2020
The TGA has issued an infringement notice for $13,320 to Brisbane-based company Cordelia International for the alleged unlawful importation of medical face masks in relation to COVID-19.
26 August 2020
The TGA has issued an infringement notice for $12,600 to Sydney-based company GenesisCare for the alleged unlawful importation of KN95 face masks in relation to COVID-19.
19 August 2020
Guidance to help determine when a face mask is a medical device and therefore must be included in the Australian Register of Therapeutic Goods (ARTG).

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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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