New draft guidance released by Australia’s Therapeutic Goods Administration spells out what steps are needed when changes affect a conformity assessment certificate for devices.
The guidance applies to devicemakers that have been issued conformity assessment certificates in Australia and want to make a change. The guidance includes events that trigger a transfer of a conformity assessment certificate and associated manufacturer responsibilities.
The guidance is one of three that the TGA will release related to new conformity assessment procedures in the Australian Regulatory Guidelines for Medical Devices. The device regulations are undergoing a major update, and TGA plans to release more guidance on a range of other issues including notified bodies, accelerated reviews for devices and other procedural changes.