文章摘要
许慧雯,郑佳,王慧超,兰禹葶,余新华.新形势下医疗器械标准化体系研究[J].中国药事,2019,33(10):1087-1092
新形势下医疗器械标准化体系研究
Study on the Medical Device Standardization System under the New Situation
投稿时间:2019-06-24  
DOI:10.16153/j.1002-7777.2019.10.001
中文关键词: 医疗器械  标准化体系  标准管理法规  组织架构
英文关键词: medical devices  standardization system  standard management regulation  organization structure
基金项目:
作者单位
许慧雯 中国食品药品检定研究院, 北京 102629 
郑佳 中国食品药品检定研究院, 北京 102629 
王慧超 中国食品药品检定研究院, 北京 102629 
兰禹葶 中国食品药品检定研究院, 北京 102629 
余新华 中国食品药品检定研究院, 北京 102629 
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中文摘要:
      目的:研究在新形势下如何不断完善、构建更好的服务于监管需要和产业发展的医疗器械标准化体系。方法:通过对医疗器械标准化工作面临的新形势、新要求进行分析,从标准管理法规建设、组织架构建设、标准体系建设的角度对医疗器械标准化体系进行研究。结果与结论:通过持续深化标准化工作改革,继续强化医疗器械标准化顶层设计,探索研究医疗器械团体标准管理模式,深入推进医疗器械强制性标准整合、精简工作,从而建立适应新形势、更加科学合理、先进适用、开放兼容、规模适度的医疗器械标准化体系。
英文摘要:
      Objective: To study how to improve and build a better medical device standardization system in order to serve the need of regualtion and industrial development under the new situation. Methods: The new situation and new requirements of the medical device standardization were analyzed. The medical device standardization system was studied from the following aspects: draft of standard management regulations, establishment of organization structure and construction of a standard system.Results and Conclusion: A more scientific and rational, advanced and applicable, open and compatible as well as appropriate-scaled medical device standardization system that adapts to new situation will be established by continuously deepening the reform of standardization, successively enhancing the top-level design of medical device standardization, exploring the management model of group standards for medical devices and further promoting the integration and simplification of mandatory standards for medical devices.
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