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目的研究我国2014年国务院发布的《医疗器械监督管理条例》(国务院650号令),系统评价其对医疗器械市场准入的要求。方法采用系统评价的层次分析法,从注册、注册变更、延续注册等七个方面的要求进行分析,并与我国要求进行比较。结果与结论《医疗器械监督管理条例》的制定体现了规制理论中根据风险分别加强规制和放松规制的思路,在许可法定、许可效率和便民、许可与监督相结合方面进行了有益的改革。为保证其能够有效地被落实和执行,必须重点做好其配套法规的修订工作,建立以《医疗器械监督管理条例》为纲领,以局令、规范性文件和指导原则为依托的全面法规体系。
Objective To study the Regulations on the Supervision and Administration of Medical Devices promulgated by the State Council in 2014 (Order No.650 of the State Council) and systematically evaluate the requirements for the market access of medical devices. Methods Analytic Hierarchy Process (AHP) was used to analyze the requirements of the seven aspects of registration, registration change and renewal registration, and compared with the requirements of our country. Results and Conclusion The Regulation of Medical Device Supervision and Management embodies the idea of strengthening regulatory and loosening regulations respectively according to risk in regulatory theory, and carries out beneficial reforms in the aspects of permitting statutory, permitting efficiency and convenient, permitting and supervising. In order to ensure that it can be effectively implemented and implemented, it is necessary to focus on the revision of its supporting laws and regulations and establish a comprehensive legal system based on the “Regulations on the Supervision and Administration of Medical Devices” and on the basis of bureaucratic ordinances, normative documents and guiding principles .