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Regulatory Authority Assessment Method for Recognition and Surveillance of Medical Device Conformity Assessment Bodies

A Proposed Document by the International Medical Device Regulators Forum (IMDRF) Good Regulatory Review Practices Working Group is provided below for public comment.

This consultation closes on Saturday, 9 May 2020.

Working Group Chairs: Melissa Torres, USA

Thank you for your contribution aiming at the validation of the IMDRF document.

Consultation documents

Reference document

Please use the comments template to provide comments on the Proposed Document and send comments via email: melissa.torres@fda.hhs.gov with the subject line 'IMDRF Consultation'.