IMDRF consultation: Competence and Training Requirements for Regulatory Authority Assessors of Conformity Assessment Bodies

This consultation closed on 26 May 2020.

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:

• Competence and Training Requirements for Regulatory Authority Assessors of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews

The TGA (together with all other working group members) invited interested parties to comment on the document.

Further information about IMDRF consultations

Further details about current (and closed) consultations, including how to make submissions, are available on the Consultations page of the IMDRF website.