31 January 2021
Information for sponsors and manufacturers about pathways for exporting a ventilator from Australia.
28 January 2021
Information to help ensure individuals and organisations clearly understand and minimise the risks of reusing face masks and gowns.
28 January 2021
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).
26 August 2020
Important information about the use of COVID-19 point-of-care tests.
3 June 2020
New modelling demonstrates that supply of critical medicines for ventilating patients supports a return to elective surgery.
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.
31 March 2020
Clarification about the clinical trial process as it relates to COVID-19
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
19 March 2020
Information for manufacturers of therapeutic goods about the suspension of all overseas GMP (Good Manufacturing Practice) inspections and QMS (Quality Management System) audits