Web Conference (hosted by the Republic of Korea)

Meeting no
19
Date
-
Location
Republic of Korea

Jurisdictional updates

Australia
Brazil
Canada
China
EU
Japan
Russia
Singapore
South Korea
UK
USA

Working group updates

Regulated Product Submission
Good Regulatory Review Practice
Adverse Event Terminology
Personalized Medical Devices
Medical Device Clinical Evaluation
Medical Device Cybersecurity Guide
Principles of In Vitro Diagnostic (IVD) Medical Devices Classification
Artificial Intelligence Medical Devices

Stakeholder updates

WHO

Stakeholders updates

IMDRF Presentation - Stakeholder Update - WHO
IMDRF Presentation - Stakeholder Update - APEC
IMDRF Presentation - Stakeholder Update - AHWP GHWP
IMDRF Presentation - Stakeholder Update - PAHO
IMDRF Presentation - Stakeholder Update - DITTA
IMDRF Presentation - Stakeholder Update - GMTA
IMDRF Presentation - Stakeholder Update - ASTM
IMDRF Presentation - Stakeholder Update - KMDICA
IMDRF Presentation - Stakeholder Update - KMDIA

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)