The applicant for medical device registration must guarantee the safety and effective of medical device within the lifetime,and submit the research information of lifetime when registering.This article collected the registration applications of active medical device for Anhui evaluation center from April 2020 to January 2022,sorted and analysed the common questions of the lifetime research information,summarized the difficulties of the study on the lifetime evaluation.Hope to improve the completeness and compliance of materials and the scientific and systematic of timelife study.Finally ensure reliable quality while accelerating the listing of medical device products.
active medical devicelifetimeresearch informationtechnical evaluation
维普
万方数据
