Consultation closed

Assessment and Decision Process for the Recognition of a Conformity Assessment Body Conducting Medical Device Regulatory Reviews

Start date
Closing date
Working group
Good Regulatory Review Practices

A Proposed Document on Assessment and Decision Process for the Recognition of a Conformity Assessment Body Conducting Medical Device Regulatory Reviews has been released by the International Medical Device Regulators Forum (IMDRF) Good Regulatory Review Practices Working Group.

Thank you for your contribution aiming at the validation of the IMDRF document.

Consultation documents

IMDRF GRRP CAB Decision Process Final Draft Document - N66

Please use the comments template to provide comments on the Proposed Document and email comments to melissa.torres [at] fda.hhs.gov (Melissa[dot]Torres[at]fda[dot]hhs[dot]gov).

Comments Template - IMDRF GRRP CAB Decision

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