You may be required to comply with these guidelines if you intend to:
- manufacture medical devices in Australia for the Australian market
- manufacture medical devices in Australia for export to overseas markets
- manufacture medical devices overseas for import into the Australian market.
The guidelines provide details about the classes of medical devices, safety, risks, performance and the clinical evidence needed to support the application for the inclusion of a medical device on the Australian Register of Therapeutic Goods.
Please consult the Contact Officer for more information and to ascertain the level of compliance (if any) that may be required.