IMDRF consultation: Good Regulatory Review Practices - Requirements for Conformity Assessment Bodies

This consultation closed on 3 October 2019.

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 their 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 one of a series of documents under development that will help to establish a common set of requirements to be utilized 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 a proposed guidance document:

• Requirements for Regulatory Authority Recognition of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews

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, following the consultation submission process detailed on the IMDRF web page, by Thursday, 3 October 2019.

Do not send your responses to the TGA.

Instructions on making comments and any enquiries are included on the IMDRF website linked above.

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.