Berlin, Germany (hosted by European Commission on behalf of the EU)

Meeting no
24
Date
-
Location
Berlin

Jurisdictional Updates

Australia (TGA)
Brazil
Canada
China
European Union
Japan
Singapore
South Korea
United Kingdom
United States of America
Argentina
Switzerland
WHO

Working Group Updates

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

Stakeholder Updates

APEC
GHWP
DITTA
GMTA
AMDF

Joint IMDRF/DITTA and GMTA Workshop - Specialized Regulatory Pathways

Overview of IMDRF foundational pathways
Devices intended for specific patient populations
Innovative Medical Devices
Regulatory toolboxes to foster innovation

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)