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