美国和日本医疗器械数据库系统构建思路探析

目的：探讨医疗器械监管先行国家的数据库系统建设思路，为我国医疗器械科学监管提供借鉴和参考。方法：分析美国和日本医疗器械数据库的功能、组织结构、数据信息相关联情况，进而探讨其数据库系统的构建思路，对比分析不同数据库的优缺点。结果与结论：两国数据库的构建基于其监管实践，注重数据库系统各层级的分工与互联。综合考虑我国的监管需求和信息化建设实际情况，建议从整体设计方面参考美国数据库分数据库独立建设，加强互联互通，实现数据库之间或数据库系统内部的有效联通。日本在构建数据库过程中，在语言和监管思路两方面兼顾国际接轨、注重监管要求的长期稳定性的思路和做法，也值得我国借鉴。

Analysis on the Idea for Establishing Medical Device Database System in United States and Japan

Objective: To explore the idea for establishing database system for medical device regulation in leading countries, so as to provide references for the scientific regulation of medical devices in China. Methods: Function, organization structure and interconnection of data information of medical device database in the United States and Japan were analyzed. The establishment idea of database system was discussed, and the advantages and disadvantages of different databases were compared and analyzed. Results and Conclusion: The construction of databases in the two countries was based on their regulatory practice and the division of labor and interconnection at all levels of the database system was highlighted. On the basis of the regulatory need and actual situation of information construction in China, it is suggested that the independent establishment of database in the United States should be referred to in the overall design, so as to strengthen the interconnection and realize the effective connection between databases or within the database system. In the process of constructing database, Japan took into account the international standards in both language and supervision, and paid attention to the long-term stability of regulatory requirements, which is worth learning for our country.