In October 2017, the General Office of the CPC Central Committee and the General Office of the State Council issued "The opinion on deepening the reform of the review and approval system and encouraging the innovation in pharmaceutical and medical devices" which clearly requires the unification of the evaluation stand for the second class medical device and realizes national review gradually. According to this requirement, this paper firstly reviews situation of foreign medical device evaluation system, and then introduces general situation of medical device review in our country, including the establishment of institutions and existed problem of medical device registrations, and corresponding reasons are also be analyzed. Finally we focus on giving proposal on how to realize the unification of class Ⅱ medical device technology review in China combined with real situation based on referring foreign experience.%2017年10月,中共中央办公厅、国务院办公厅印发《关于深化审评审批制度改革鼓励药品医疗器械创新的意见》,明确要求统一第二类医疗器械审评标准,逐步实现国家统一审评.根据该要求,该文首先介绍国外医疗器械审评制度的优缺点,其次介绍我国医疗器械技术审评概况,包括机构设置及当前技术审评中存在的问题,并着重分析问题产生的原因.最后借鉴国外经验,并结合我国医疗器械审评实际,对如何实现我国第二类医疗器械统一审评提出建议.
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