Media Update, page-1510

https://www.tga.gov.au/covid-19-rapid-antigen-tests-information-manufacturers-and-sponsors

‘Expedited’

COVID-19 medical device application processThe Therapeutic Goods Administration (TGA) is currently undertaking an expedited assessment process for all medical devices associated with the detection, prevention and treatment of COVID-19. We are committed to supporting suppliers with the Australian requirements and encourage potential suppliers to submit an application for inclusion on the Australian Register of Therapeutic Goods (ARTG). Sponsors are not required to request or submit a priority review as all applications in relation to COVID-19 tests are already being expedited as a matter of priority in assessment queues.We are committed to supporting sponsors to understand the Australian regulatory requirements for the supply of COVID-19 related medical devices, including test kits.