The NMPA released the IMDRF (International Medical Device Regulators Forum) draft document of “PMCF (Post-Market Clinical Follow-Up) Studies” on October 22, 2020. The proposed document was passed by the IMDRF member states and it’s currently seeking comments from the industry. Feedback needs to be submitted by December 11, 2020.
NMPA Post-Market
PMCF study is one of several options available in a post-market surveillance program and contributes to the risk management process. It refers to research carried out after marketing authorization. It’s intended to answer uncertainties relating to safety, clinical performance and/or effectiveness of a device when used in accordance with its approved labeling.
This document provides guidance in relation to:
- Circumstances where a PMCF study is indicated
- Objectives of PMCF studies
- Ddesign and implementation of PMCF studies
- Use of information from PMCF studies
It also provides relevant Annexes:
- Examples of Clinical Experience Data Sources for PMCF
- Considerations for Using Clinical Experience Data for PMCF Studies
- Potential Biases in PMCF Studies and Controlling Methods
This project was conducted by the Medical Device Clinical Evaluation Working Group of IMDRF which is a voluntary group of medical device regulators from around the world. The document has been subject to consultation throughout its development. Please email info@chinameddevice.cn to get the completed English version of the document.
Please email info@chinameddevice.cn to get the completed English or Chinese version of the document. If you have any suggestions or opinions about PMCF studies, please submit to us by December 11, 2020.