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IMDRF consultation: Recognition and Surveillance of Medical Device Conformity Assessment Bodies
This consultation closed on 9 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:
- Regulatory Authority Assessment Method for Recognition and Surveillance of Medical Device Conformity Assessment Bodies
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 Saturday, 9 May 2020.
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.