Consultation closed

Proposed update to Clinical Evaluation documents

Start date
Closing date
Working group
Medical Device Clinical Evaluation

Proposed Documents have been released by the International Medical Device Regulators Forum (IMDRF) Medical Devices Clinical Evidence Working Group.

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

Consultation documents

Clinical Evaluation - IMDRF MDCE WG (WD)/Nx (formerly GHTF/SG5/N2R8:2007)
Clinical Evidence - Key Definitions and Concepts - IMDRF MDCE WG (WD)/Nx (formerly GHTF/SG5/N1R8:2007)
Clinical Investigation - IMDRF MDCE WG (WD)/Nx (formerly GTHF/SG5/N3:2010)

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 N2R8 2007) Clinical Evaluation
Comments Template - IMDRF MDCE WG (WD) Nx (formerly GHTF SG5 N1R8 2007) Clinical Evidence - Key Definitions and Concepts
Comments Template - IMDRF MDCE WG (PD1) Nx (formerly GTHF SG5 N3 2010) Clinical Investigation

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)