我国医疗器械分类目录修订框架设计的研究

Study of Framework Design of Revision of Medical Device Classification Catalog

目的:为行业监管人员和分类管理相对人深入理解新版分类目录提供参考。方法:在对现行医疗器械分类目录充分研究的基础上,结合医疗器械分类管理改革的要求,借鉴发达国家的管理模式和经验,提出改革医疗器械分类目录框架的建议和新框架方案,介绍了新版医疗器械分类目录框架设计过程、综合考虑因素。结果和结论:对比现行有效的分类目录,新版医疗器械分类目录的层级结构和内容更丰富,产品覆盖面更广,更有利于与国际接轨。

Objective： To provide references for industry supervisors and classification management counterparts to better understanding the new classification catalog in China. Methods： Some suggestions for reforming the framework design catalog of medical devices and a new framework program were put forward on the basis o5 the full study of current medical device catalog, combined with the requirements of medical device classification management reform and the management mode and experience of developed countries. Both the process of framework design of new version medical device classification catalog and the comprehensive considerations were introduced. Results and Conclusion： Compared with the current classification catalog of medical devices, the new version medical device classification catalog has higher hierarchical structure, richer content and wider product coverage and is more conducive to international integration.