Active medical device is a kind of medical device which is widely used. In order to realize the goal of high-quality development, product with high reliability is a necessary requirement for the domestic active medical device industry. By means of literature research, data collection, field research, materials comprehensive combing and analysis, this paper systematically analyzes and studies the current situations and the existing problems of reliability and evaluation from the dimensions of Chinese active medical device industry policy, enterprise situation and evaluation method. In addition, by considering the technical characteristics of reliability work, concrete suggestions for solving the problems are given from the directions of standard and guiding principle, so as to provide reference for active medical device industry to develop scientific and objective reliability technical standard system and guiding principle, which are in accord with the current characteristics of Chinese active medical device industry and supervision.
有源医疗器械是使用范围比较广泛的医疗器械产品，产品具备高可靠性水平是国产有源医疗器械产业实现高质量发展目标的必要要求。本文通过文献研究、资料收集、实地调研、材料综合梳理分析等方式，从产业政策、企业开展情况和审评方法等维度对我国有源医疗器械行业可靠性及其审评现状和存在的问题进行了系统的分析研究，并结合可靠性工作的技术特点，从标准和指导原则两个方向给出具体的问题解决建议，为后续行业制定科学、客观、符合我国行业现状和监管特点的有源医疗器械可靠性技术标准体系和指导原则提供参考。.
Keywords: Active medical devices; Current situations; Evaluation; Reliability.