Open consultations
IMDRF Training Registration - 13 Sep 2026
You can register to attend the event virtually or in-person. Date: 13 September 2026 Time: 9am-3.30pm (Singapore local time, GMT+8) Venue: HSA Auditorium Level 1, 11 Outram Road, Singapore 169078 Note: In-person attendance is capped at 100 participants, with places allocated as registrations are received.
Closed consultations and engagement
IMDRF Consultation Feedback - Essential Principles and Content of PCCP (N90 - SaMD WG)
This document serves to facilitate international convergence and harmonize approaches across 90 jurisdictions by describing essential principles for Predetermined Change Control Plans (PCCPs). ...
IMDRF Consultation Feedback - CE IVD WG - Definitions and Principles of Performance Evaluation
This document supersedes earlier documents produced under the Global Harmonization Task Force (GHTF): GHTF/SG5/N6:2012 Clinical Evidence for IVD medical devices – Key Definitions and Concepts and...
IMDRF Survey - Use of IMDRF/MDSAP WG/N24 (Medical Device Regulatory Audit Reports)
The International Medical Device Regulators Forum (IMDRF) publishes documents to support global medical device regulatory harmonization and convergence. IMDRF is seeking feedback...
