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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 November 2020
A list of ventilators that meet minimum requirements and are permitted to be supplied under the COVID-19 Emergency Exemption.
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.
12 August 2020
Information for sponsors and manufacturers about pathways for exporting a ventilator from Australia.
3 August 2020
The TGA has established an expedited recall pathway for faulty or unauthorised COVID-19 devices
3 June 2020
New modelling demonstrates that supply of critical medicines for ventilating patients supports a return to elective surgery.
4 May 2020
To assist healthcare facilities, the TGA has provided guidance to assist with sourcing additional equipment to treat patients in the event of a shortage of ventilators and other respiratory support devices.
17 April 2020
The TGA has been involved in exploring ways to further increase supply of ventilators when and where they are needed
7 April 2020
This new specification details the minimum technical requirements for manufactured invasive ventilators when approved devices are not available during the COVID-19 emergency.
2 April 2020
Information about the steps we are taking to make sure there are enough ventilators to match demand during the COVID-19 pandemic

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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