Chen Lei, Li Meng
Chinese Pharmacopoeia Commission, Beijing, 100061.
Beijing Institute of Medical Device Testing, Beijing, 101111.
Zhongguo Yi Liao Qi Xie Za Zhi. 2017 Jul 30;41(4):275-278. doi: 10.3969/j.issn.1671-7104.2017.04.011.
To analyze the current situation about informatization construction of medical device administration in China, including such links of market access of medical device, occupation access of enterprise, risk monitoring of postmarketing, sampling and testing of post-marketing, complaint and inspecting, advertising management and standard management. By the informatization of medical device administration, some supervision problems can be solved, supervision efficiency can be promoted. For accelerating the informatization construction of medical device administration, we should do top-level design and implement by step, pay more attention to the informatization of manufacturing enterprise, product tracing and standard management, in order to continually improve the level of medical device administration.
分析我国医疗器械监管信息化建设现状，包括医疗器械市场准入、企业从业准入、上市后风险监测、上市后抽样检验、投诉举报与稽查、广告管理以及标准管理等环节。通过医疗器械监管信息化，可解决部分监管问题，提升监管效率。为加快医疗器械监管信息化建设，应做好顶层设计并分步实施，更加注重生产企业信息化、产品追溯及标准管理，以不断提高医疗器械监管水平。
