我国医疗器械监管信息化的探讨

Study on Informatization of Medical Device Administration in China

该文着重分析了我国国家和地方医疗器械监管信息化的现状,包括产品市场准入、企业从业准入、产品上市后风险监测、产品上市后抽验、投诉举报与稽查、广告管理、标准管理等环节的信息化进展及特点。并阐述了借助医疗器械监管信息化,可以破解监管难题,提升监管效能,实现智慧监管。进而建议要推进医疗器械监管信息化,应做好顶层设计、统筹谋划,分类推进、分步实施,并以生产企业、产品追溯、产品标准信息化为重点,促进医疗器械监管和服务水平的不断提高。

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 post- marketing, 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.