Procedural document

IMDRF Standard Operating Procedures

IMDRF Code
IMDRF/MC/N2
Published date
IMDRF code: IMDRF/MC/N2FINAL:2025 (Edition 13 Version 2)
Published date:
IMDRF/MC/N2FINAL:2025 (Edition 13 Version 2)

IMDRF code: IMDRF/MC/N2 FINAL:2019 (Edition 5)
Published date:
IMDRF Standard Operating Procedures
IMDRF code: IMDRF/MC/N2 FINAL:2020 (Edition 6)
Published date:
IMDRF Standard Operating Procedures
IMDRF code: IMDRF/MC/N2 FINAL:2021 (Edition 7)
Published date:
IMDRF Standard Operating Procedures
IMDRF code: IMDRF/MC/N2FINAL:2022 (Edition 8)
Published date:
IMDRF Standard Operating Procedures December 2022
IMDRF code: IMDRF/MC/N2FINAL:2023 (Edition 9)
Published date:
IMDRF/MC/N2FINAL:2023 (Edition 9)
IMDRF code: IMDRF/MC/N2FINAL:2023 (Edition 10)
Published date:
IMDRF/MC/N2FINAL:2023 (Edition 10)
IMDRF code: IMDRF/MC/N2FINAL:2024 (Edition 12)
Published date:
IMDRF/MC/N2 FINAL:2024 (Edition 12)
IMDRF code: IMDRF/MC/N2FINAL:2025 (Edition 13)
Published date:
IMDRF/MC/N2FINAL:2025 (Edition 13)

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

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)

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)

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)