本文概述了当前国内体外诊断试剂分类管理的现状,结合上海三甲医院体外诊断试剂使用与管理中存在的问题及原因分析,借鉴欧美发达国家体外诊断试剂的监管经验,提出对上海三甲医院体外诊断试剂监管的对策。 This paper summarizes the current status of the classification management of IVD reagents in China, combining with the problems and reasons in the use and management of IVD reagents in Shanghai AAA, draws on the regulatory experience of in vitro diagnostic reagents from developed countries in Europe and the United States, Regulatory measures.