3 August 2020
The TGA has established an expedited recall pathway for faulty or unauthorised COVID-19 devices
30 July 2020
Guidance to assist manufacturers of medical devices and their component parts with meeting their regulatory obligations.
3 June 2020
New modelling demonstrates that supply of critical medicines for ventilating patients supports a return to elective surgery.
21 May 2020
Information to help ensure individuals and organisations clearly understand and minimise the risks of reusing face masks and gowns.
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
16 April 2020
During the COVID-19 pandemic, many businesses are encountering therapeutic goods regulations for the first time. This information explains the labelling requirements for medical devices to help manufacturers and sponsors meet their obligations.
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
24 March 2020
Certain medical devices for the diagnosis and treatment of COVID-19 will be exempt from various provisions of the therapeutic goods act to facilitate necessary access