目的：探讨日本医疗器械监管数据库建设与分类命名工作思路，为我国医疗器械监管信息化建设提供技术支撑。方法：解析日本医疗器械一般名称（JMDN）数据库结构层级，分析其分类命名信息。结果与结论：数据库的建立与管理体现了日本医疗器械的监管立足于本国实际，保持与国际监管思路的良好接轨，注重法规的长期稳定性和实际可操作性的工作思路，对进一步完善我国医疗器械信息化建设具有重要借鉴意义。
Objective: To discuss the construction, classification and nomenclature of medical device regulatory databases in Japan in order to provide technical support for the construction of medical device regulation informationization in China. Methods: The structure, classification and nomenclature of Japanese medical device nomenclature (JMDN) databases were analyzed. Results and Conclusion: The establishment and management of the JMDN databases have reflected the facts that the medical device supervision in Japan is linked to the actual situation of the country, and the idea keeps in line with the international regulations and pays attention to the longterm stability and practical operability of the regulations, all of which will provide an important reference for further improving the construction of medical device regulation informationization in China.
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