One of the recommendations accepted by the Australian Government from the Expert Panel Review of Medicines and Medical Devices Regulation (the Review) was a better utilisation of marketing approvals of medical devices, including IVD medical devices, where the device has been:
conformity assessed by a body that has been designated to undertake conformity assessments by a comparable overseas designating authority; or
approved by a comparable overseas national regulatory authority.
The purpose of this guidance is to provide an overview of how specific overseas assessments and approvals can be used by applicants for:
supporting a possible abridged assessment of an application for a TGA conformity assessment certificate, or
as the documentation required to be provided with applications for inclusion of medical devices (including IVDs) in the ARTG.
These arrangements are prescribed by the following instruments:
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.