On October 11, the CMDE (Center for Medical Device Evaluation) of NMPA (National Medical Products Administration) published the Post-Market Clinical Follow-Up Studies for Medical Devices (draft) on the official website of the IMDRF (International Medical Device Regulator Forum).
The proposal document (in English and Chinese) provides guidance in relation to:
– The circumstances where a post-market clinical follow-up (PMCF) study is indicated
– The general principles of PMCF studies involving medical devices
– The design and implementation of PMCF studies
– The use of information from PMCF studies
Although PMCF studies are not intended to replace the premarket data necessary for market authorization, it is one of the several options available in a post-market surveillance program and can contribute to the risk management process.
The acceptance by IMDRF of China’s proposal on PMCF studies is significant, because it shows the growing global leadership and maturity of the Chinese regulator and medical device industry. It is also likely to soon result in updated regulation of PMCF studies in China. Such studies are an important supplement to a manufacturer’s post-market compliance.
IMDRF is a voluntary group formed by regulators from the global medical device industry. The public consultation is currently open for comments until December 11, 2020. Let us know if you would like to send us your comments on the draft, and together we can submit a strong proposal to the CMDE and IMDRF.
By Jacky Li. Contact Cisema if you would like to learn more.
