Proposed update to document on Post-Market Clinical Follow-Up Studies
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.
This consultation closed on Friday, 11 December 2020.
Working Group Chair: Liu Yinghui
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) (PDF, 320kb)
- Post-Market Clinical Follow-up Studies - IMDRF MDCE WG(PD1)/Nx (formerly GHTF/SG5/N4:2010) (DOC, 131kb)
Please use the comments template to provide comments on the Proposed Document and email comments to liuyh@cmde.org.cn.