IMDRF consultation: Assessment and Decision Process for the Recognition of a Conformity Assessment Body Conducting Medical Device Regulatory Reviews

This consultation closed on 19 April 2021.

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 of the U.S. Food and Drug Administration.

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 used 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 is seeking comments from interested parties on the proposed guidance document, which outlines the process used to evaluate CAB performance and the possible outcomes if performance issues are identified.

• Assessment and Decision Process for the Recognition of a Conformity Assessment Body Conducting Medical Device Regulatory Reviews (pdf,1.22Mb)

The TGA, together with all other working group members, invite interested parties to comment on the document.

Deadline for submissions

Interested parties should make submissions using the provided template, directly to the IMDRF working group contact via the consultation submission process detailed on the IMDRF web page, by 19 April 2021.

Do not send your consultation submission to the TGA.

However, if you wish to seek clarification from Australia’s representative on this working group regarding any aspect of the draft document prior to making your submission to IMDRF, please send questions to dcas@health.gov.au and the TGA representative will be in touch.

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.