Tokyo, Japan (Hosted by Japan)

Meeting no
27
Date
-
Location
Tokyo, Japan

Note: Outcome Statement currently being finalised and will be published here soon

Jurisdictional Updates

Argentina
Australia
Brazil
Canada
China
Japan
Korea
Russia
Saudi Arabia
Singapore
Switzerland
The World Health Organization
United Kingdom

Working Group Updates

Adverse Event Terminology Working Group
Artificial Intelligence Machine Learning-enabled Working Group
Good Regulatory Review Practices Working Group
Clinical Evidence for IVD Working Group
Personalized Medical Devices Working Group
Quality Management Systems Working Group
Regulated Product Submission Working Group
Software as a Medical Device Working Group

Joint IMDRF/Industry Workshop - Strategic Plan/Reliance

IMDRF Strategic Plan 2026 – 2030 - Scene Setting
Progress and challenges in Implementation of IMDRF guidance documents
Education models for Training and Capacity Building at Current IMDRF initiatives, RHI experience
Challenges in expanding Reliance

Member sites

Regional harmonization initiatives

APEC LSIF Regulatory Harmonization Steering Committee

Global Harmonization Working Party (GHWP)

Pan American Health Organization (PAHO)

African Medical Devices Forum (AMDF)

Official observers

Argentina, National Administration of Drugs, Food and Medical Devices

The World Health Organization (WHO)

Saudi Arabia, Saudi Food and Drug Authority

Switzerland, Swissmedic

Affiliate members

Botswana - Botswana Medicines Regulatory Authority (BoMRA)

Chile - Public Health Institute of Chile (ISP)

Chinese Taipei Taiwan Food and Drug Administration (TFDA)

Costa Rica - Ministry of Health

Cuba - Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos (CECMED)

Dominican Republic - General Directorate of Medicines, Food and Health Products (DIGEMAPS)

Egypt - Egyptian Drug Authority  (EDA)

El Salvador - Sanitary Regulation Superintendency (SRS)

Ethiopia - Ethiopian Food and Drug Authority (EFDA)

India - Central Drugs Standard Control Organization (CDSCO)

Israel - The Medical Technology, Health Information, Innovation and Research Directorate (MTIIR)

Affiliates

 

Jordan - Jordan Food and Drug Administration (JFDA)

Kenya - Pharmacy and Poisons Board (PPB)

Mexico - Federal Commission for Protection from Sanitary Risks (COFEPRIS)

Montenegro - Institute for Medicine and Medical Devices of Montenegro (CINMED)

Nigeria - National Agency for Food and Drug Administration Control (NAFDAC)

Oman - Drug Safety Center, Medical Device Control Department (DSC)

Paraguay - National Health Surveillance (DINAVISA)

Peru - General Directorate of Medicines, Supplies and Drugs (DIGEMID)

South Africa - South African Health Products Regulatory Authority (SAHPRA)

Tanzania - Tanzania Medicines and Medical Devices Authority (TMDA)

Zimbabwe - Medicines Control Authority (MCAZ)