Technical document

Competence and Training Requirements for Regulatory Authority Assessors of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews

IMDRF Code
IMDRF/GRRP WG/N63
Published date
Status
Final
IMDRF code: IMDRF/GRRP WG/N63FINAL:2020
Published date:
Competence and Training Requirements for Regulatory Authority Assessors of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews

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

SAHPRA - South African Health Products Regulatory Authority

TFDA - Taiwan Food and Drug Administration

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

EDA - Egyptian Drug Authority 

MTIIR (Israel) - The Medical Technology, Health Information, Innovation and Research Directorate

ISP - Public Health Institute of Chile

CinMED - Institute for Medicine and Medical Devices of Montenegro