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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.
24 April 2020
Where suitable, TGA inspectors will undertake remote and/or hybrid Good Manufacturing Practice (GMP) domestic inspections during the COVID-19 pandemic.
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

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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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