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Consultation - Guidance on the Control of Products and Services Obtained from Suppliers

Reminder: The current consultation regarding Guidance on the Control of Products and Services Obtained from Suppliers will close on 6 July, 2026.
25 June 2026

Consultation - Clinical Evidence for IVD Medical Devices – Definitions and Principles of Performance Evaluation

Reminder: The current consultation on IMDRF/CEIVD WG/N91 Draft: 2026 – Clinical Evidence for IVD Medical Devices: Definitions and Principles of Performance Evaluation will close on 5 May 2026.
23 April 2026

Voluntary Withdrawal of GHWP

Global Harmonization Working Party (GHWP) has voluntarily withdrawn from IMDRF.
8 July 2025

IMDRF Membership Forms now online

From May 2025, all IMDRF related forms will be available online from IMDRF’s Citizen Space site.
13 May 2025

Essential Principles of Safety and Performance - Workshop

Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices: Workshop record available fthrough GRRP Working Group
8 November 2024

IMDRF Working Group Updates available for review and feedback

IMDRF Working Group Updates to the 24th IMDRF MC Session available for review and feedback
8 September 2023

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14 July 2023

IMDRF Strategic Plan 2021-2025 - Progress Report Card

IMDRF Strategic Plan 2021-2025 - Progress Report Card
8 May 2023

Outcome statement available - 23rd IMDRF Meeting in Brussels, March 2023

23rd MC Meeting - Brussels Outcome Statement
28 April 2023

White Paper - 23rd IMDRF Session Joint Workshop by IMDRF – DITTA and GMTA: Importance of post-market related activities

White Paper - 23rd IMDRF Session Joint Workshop by IMDRF – DITTA and GMTA - Importance of post-market related activities
28 April 2023

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Member sites

Therapeutic Goods Administration

Brazilian Health Regulatory Agency (ANVISA)

Health Canada

National Medical Products Administration

European Commission - Directorate-General for Health and Food Safety

Pharmaceutical and Medical Devices Agency (PMDA)

Ministry of Health, Labour and Welfare (MHLW)

Russian Ministry of Health

Health Sciences Authority

Ministry of Food and Drug Safety

Medicines and Healthcare products Regulatory Agency

US Food and Drug Administration

Swissmedic

Regional harmonization initiatives

APEC Regulatory Harmonization Steering Committee (RHSC)

Pan American Health Organization (PAHO)

African Medical Devices Forum (AMDF)

South-East Asia Regulatory Network (SEARN)

Official observers

Argentina, National Administration of Drugs, Food and Medical Devices

The World Health Organization (WHO)

Saudi Arabia, Saudi Food and Drug Authority

Affiliate members

Botswana - Botswana Medicines Regulatory Authority (BoMRA)

Chile - Public Health Institute of Chile (ISP)

Chinese Taipei - Taiwan Food and Drug Administration (TFDA)

Colombia - Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA)

Costa Rica - Ministry of Health (MoH)

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)

Ghana - Foods and Drug Authority (Ghana)

India - Central Drugs Standard Control Organization (CDSCO)

Indonesia - Ministry of Health (MoH)

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)

Malaysia - Medical Device Authority (MDA)

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)

Philippines - Food and Drug Administration (FDA)

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

Tanzania - Tanzania Medicines and Medical Devices Authority (TMDA)

Uzbekistan - The Center for Pharmaceutical Products Safety

Zanzibar - Zanzibar Food and Drug Agency (ZFDA)

Zimbabwe - Medicines Control Authority (MCAZ)

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