Bioexcelife
Overview
The International Medical Device Regulators Forum (IMDRF) continues its mission to harmonise and strengthen global medical device regulations. By accelerating international regulatory convergence, IMDRF aims to build a more efficient, effective, and responsive global regulatory model—one that keeps pace with rapid technological innovation while ensuring public health and safety.
28th IMDRF Management Committee Meeting — Sapporo, Japan 🇯🇵
The 28th IMDRF Management Committee Meeting was successfully hosted by the Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA) in Sapporo, Japan, from 15 to 19 September 2025.
This high-level meeting brought together global regulators to discuss emerging challenges, policy alignment, and collaborative pathways to streamline device approvals worldwide.
👉 Presentations and the official outcome statement from this session are now available under the IMDRF “Meetings” section for public reference.
New Affiliate Members Welcomed
In a move that reflects growing global participation in regulatory harmonisation, IMDRF announced the inclusion of four new affiliate members:
- 🇨🇴 Colombia (INVIMA)
- 🇬🇭 Ghana (FDA)
- 🇮🇩 Indonesia (Ministry of Health)
- 🇵🇭 Philippines (FDA)
Their entry signifies an important step toward a truly global regulatory ecosystem, where shared standards and data exchange can accelerate safe access to medical technologies.
Leadership for 2025
For 2025, the Chair and Secretariat of IMDRF are being held by Japan.
Future rotations of leadership are available on the IMDRF website, ensuring transparency and continuity in global collaboration.
Why This Matters
IMDRF’s ongoing work supports smoother international submissions, mutual recognition of evaluations, and faster access to life-saving innovations — especially important as AI-driven devices and digital health tools continue to reshape global healthcare.
Key Takeaway
The 28th IMDRF meeting reaffirms the world’s shared commitment to regulatory convergence and public health protection.
As more countries align with IMDRF principles, the pathway for medical devices from innovation to patient becomes more unified, predictable, and patient-centric.
