Consultation closed

Regulatory Authority Assessment Method for Recognition and Surveillance of Medical Device Conformity Assessment Bodies

Start date
Closing date
Working group
Good Regulatory Review Practices

A Proposed Document by the International Medical Device Regulators Forum (IMDRF) Good Regulatory Review Practices Working Group is provided below for public comment.

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

Consultation documents

Regulatory Authority Assessment Method for Recognition and Surveillance of Medical Device Conformity Assessment Bodies

Please use the comments template to provide comments on the Proposed Document and send comments via email: melissa.torres [at] fda.hhs.gov (melissa[dot]torres[at]fda[dot]hhs[dot]gov) with the subject line 'IMDRF Consultation'.

Recognition Requirements for Conformity Assessment Bodies
Regulatory Authority Assessment Method for Recognition and Surveillance of Medical Device Conformity Assessment Bodies

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)

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

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)