检索规则说明:AND代表“并且”;OR代表“或者”;NOT代表“不包含”;(注意必须大写,运算符两边需空一格)
检 索 范 例 :范例一: (K=图书馆学 OR K=情报学) AND A=范并思 范例二:J=计算机应用与软件 AND (U=C++ OR U=Basic) NOT M=Visual
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.
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]
正在载入数据...
正在载入数据...
正在载入数据...
正在载入数据...
正在载入数据...
正在载入数据...
正在载入数据...
正在链接到云南高校图书馆文献保障联盟下载...
云南高校图书馆联盟文献共享服务平台 版权所有©
您的IP:216.73.216.15