Once the certificates are accepted, the Australian sponsor can proceed with an application to include the medical device in the ARTG. The device cannot be legally supplied to the market in Australia unless the application for inclusion is approved, as a valid ARTG entry must exist prior to supply.
No further assessment will be conducted by the TGA for IVDs that are covered by a TGA Conformity Assessment Certificate.
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.