| 杜晓丹,苑富强,陈鸿波,杨昭鹏.《医疗器械检验机构能力建设标准》编制构想[J].中国药事,2017,(10):1137-1141 |
| 《医疗器械检验机构能力建设标准》编制构想 |
| Conceptions and Suggestions for Compilation of Standards of the Capacity Construction of Medical Device Testing Institutions |
| 投稿时间：2017-08-05 |
| DOI：10.16153/j.1002-7777.2017.10.007 |
| 中文关键词: 医疗器械 检验机构 能力建设 标准 构想 建议 |
| 英文关键词: medical device testing institution capacity construction standards conceptions suggestions |
| 基金项目: |
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| 摘要点击次数: 845 |
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| 中文摘要: |
| 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。 |
| 英文摘要: |
| 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 institutions can be divided into two levels:national level and provincial level. The standards will be compiled from the following aspects, such as institutional management, business capability, equipments and environmental facilities, professional and technical personnel, scientific research capability and informatization construction capability, etc. |
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