医疗器械检验机构能力建设标准编制构想-中国药事.PDFVIP

中国药事 2017年10月 第31卷 第10期 1137 《医疗器械检验机构能力建设标准》编制构想 * 杜晓丹，苑富强，陈鸿波，杨昭鹏 （中国食品药品检定研究院，北京 100050） 摘要 目的：通过承担国家食品药品监督管理总局政策研究课题“医疗器械检验机构能力建设标准研究” 任务，提出医疗器械检验机构能力建设标准编制构想和建议。方法：组织召开各医疗器械检验机构负责 人研讨会及行业内专家咨询会，对医疗器械检验机构能力建设标准编制的内容和亟待解决的问题进行了讨 论，对编制的重点和难点进行分析；通过查阅文件，对医疗器械检验机构建设相关的政策进行梳理。结果 与结论：为顺应医疗器械技术监管发展需要，编制《医疗器械检验机构能力建设标准》迫在眉睫。可将医 疗器械检验机构分为国家级和省级两个层次，分别从机构管理、业务能力、仪器设备与环境设施、专业技 术人员、科研能力和信息化建设能力等方面展开《医疗器械检验机构能力建设标准》编制。 关键词： 医疗器械；检验机构；能力建设；标准；构想；建议 R95 R197 A 1002-7777(2017)10-1137-05 中图分类号： ； 文献标识码：文章编号： doi:10.16153/j.1002-7777.2017.10.007 Conceptions and Suggestions for Compilation of Standards of the Capacity Construction of Medical Device Testing Institutions * Du Xiaodan, Yuan Fuqiang, Chen Hongbo, Yang Zhaopeng (National Institutes for Food and Drug Control, Beijing 100050, China) Abstract Objective: To put forward the conceptions and suggestions for compilation of standards of the Capacity Construction of Medical Device Testing Institutions through undertaking the relative policy research project of the State Food and Drug Administration. Methods: Seminars of facility managers of medical device testing institutions and expert consulting meetings were held. The contents and problems to be solved in the compilation of the standards were discussed. The key points and difficulties of compilation of the standards were analyzed. Moreover, the construction-related policies of medical device testing institutions were analyzed through document reviews. Results and Conclusion: In order to meet the needs of the development of medical device technical supervision, it is urgent to compile the standards of the capacity construction of medical device testing institutions. Medical device testing institu