新形势下医疗器械标准化体系研究  被引量:10

Study on the Medical Device Standardization System under the New Situation

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作  者:许慧雯[1] 郑佳[1] 王慧超 兰禹葶 余新华[1] Xu Huiwen;Zheng Jia;Wang Huichao;Lan Yuting;Yu Xinhua(National Institutes for Food and Drug Control,Beijing 102629, China)

机构地区:[1]中国食品药品检定研究院

出  处:《中国药事》2019年第10期1087-1092,共6页Chinese Pharmaceutical Affairs

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。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.

关 键 词:医疗器械 标准化体系 标准管理法规 组织架构 

分 类 号:R197.39[医药卫生—卫生事业管理] R318[医药卫生—公共卫生与预防医学]

 

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