Consultation closed

Proposed update to document on Post-Market Clinical Follow-Up Studies

Start date
Closing date
Working group
Medical Device Clinical Evaluation

A Proposed Document on Post-Market Clinical Follow-up Studies has been released by the International Medical Device Regulators Forum (IMDRF) Medical Devices Clinical Evaluation Working Group.

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

Consultation documents

Post-Market Clinical Follow-up Studies - IMDRF MDCE WG(PD1)/Nx (formerly GHTF/SG5/N4:2010)

Please use the comments template to provide comments on the Proposed Document and email comments to liuyh [at] cmde.org.cn (liuyh[at]cmde[dot]org[dot]cn).

Comments Template - IMDRF MDCE WG (WD) Nx (formerly GHTF/SG5/N4:2010) Post-Market Clinical Follow-up Studies

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)