Information document

Medical Devices: Post-Market Surveillance: National Competent Authority Report Exchange Criteria and Report Form

IMDRF Code
IMDRF/NCAR WG/N14 FINAL:2023 (Edition 4)
Published date

Link to archived Technical Document including earlier releases here

IMDRF code: IMDRF/NCAR WG/N14 FINAL:2023 (Edition 4)
Published date:
Post Market Surveillance National Competent Authority Report Exchange Criteria and Report Form

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

World Health Organization (WHO)

Swissmedic

Affiliate members

Chile - Public Health Institute of Chile (ISP)

Chinese Taipei Taiwan Food and Drug Administration (TFDA)

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

Egypt - Egyptian Drug Authority  (EDA)

El Salvador - National Directorate of Medicines (DNM)

Ethiopia - Ethiopian Food and Drug Authority (EFDA)

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)

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

Tanzania - Tanzania Medicines and Medical Devices Authority (TMDA)