With the exception of Class III and Active Implantable Medical Devices (AIMDs), an entry in the ARTG is for a kind of medical device, meaning more than one device can be authorised for marketing by that entry.
Under section 41GO of the Act, a cancellation can be limited by the Secretary if satisfied that the grounds for cancellation apply to only one device, or only some of the devices, covered by the entry. In such a case, rather than the entry being cancelled, the entry is varied by the Secretary under that section to make it clear that marketing authorisation does not extend to the cancelled device.
The records below include information on the types of cancellation decisions described above and any subsequent decisions to revoke such cancellations. To find out whether a product is currently authorised for supply in Australia, check the ARTG entry.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.