Updates from the international Medical Device Regulators forum
Posted on 02.10.2025
The 28th International Medical Device Regulators Forum (IMDRF) Management Committee (MC) Meeting was recently held in Sapporo, Japan, on 15 – 19 September 2025. It was chaired by Japan and hosted by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). MedTech Europe participated to the event as representative of the Global Medical Technology Alliance (GMTA).
The event took place with palpable growing interest from regulators to join the IMDRF. In particular, the IMDRF Management Committee welcomed:
- Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA) – Colombia as an Affiliate Member
- Food and Drugs Authority (FDA) – Ghana as an Affiliate Member
- Ministry of Health (MoH) – Indonesia as an Affiliate Member
- Food and Drug Administration (FDA) – Philippines as an Affiliate Member
The MC also agreed to approve the draft document on “Essential Principles and Content of Predetermined Change Control Plans” for a 60-day public consultation. A New Work Item Proposal (NWIP) to develop a new guidance document on Cybersecurity Controls and Testing Considerations, and the revision of IMDRF/GRRP WG/N52 on Labelling were also approved. Finally, the MC agreed to close the Regulated Product Submission WG and to create a training page on the IMDRF website for central access to IMDRF training materials.
All relevant documents and Outcome Statement from the event can be found here.