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.

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

Asian Harmonization Working Party

Pan American Health Organization (PAHO)

Official observers

Argentina, National Administration of Drugs, Food and Medical Devices

UK, Medicines and Healthcare products Regulatory Agency

World Health Organization (WHO)