The International Medical Device Regulators Forum (IMDRF) working group on Good Regulatory Review Practices seeks to develop guidance that establishes good regulatory review practices for Regulatory Authorities and/or Conformity Assessment Bodies (CABs), and to promote global harmonisation in the premarket review processes. The working group chair is Melissa Torres (USA FDA).
This draft IMDRF document is part of a series that is under development that will help to establish a common set of requirements to be utilised by Regulatory Authorities for the recognition and monitoring of entities that perform regulatory reviews of medical devices, including IVDs medical devices.
The IMDRF working group sought comments from interested parties on this proposed guidance document:
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.