For information on accessing rapid antigen tests and what to do if you test positive, go to COVID-19 testing on the Department of Health website.
These guidelines provide details and guidance on the clinical evidence requirements for medical devices, including in vitro diagnostic medical devices (IVDs), under Australian legislation. For IVDs, there is also a supplementary document titled 'Clinical evidence guidelines supplement: In vitro diagnostic (IVD) medical devices', which should be reviewed in conjunction with these guidelines.
Due to COVID-19 pandemic and delays in EU MDR implementation
The Therapeutic Goods Administration is part of the Health Products Regulation Group