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实施医疗器械质量认证 护航民族产品走向市场
引用本文:刘奔,孙志辉,李咏雪,刘蕊,杨冬. 实施医疗器械质量认证 护航民族产品走向市场[J]. 医疗卫生装备, 2013, 0(12): 115-116,121
作者姓名:刘奔  孙志辉  李咏雪  刘蕊  杨冬
作者单位:[1]总后卫生部计生办,北京100842 [2]总后卫生部药品仪器检验所,北京100071
摘    要:在分析了国产医疗器械产业现状的基础上,阐明了质量认证对于提高产品的综合性能、增强市场竞争力的重要性。系统介绍了国内的认证制度及在维护产品质量和安全等方面发挥的重要作用,并列举了医疗器械市场上常见的相关认证,最后指出了医疗器械要积极参与各种质量认证,健全管理体系,使医疗器械行业更加健康的发展。

关 键 词:医疗器械  认证  质量安全

Medical Equipment Quality Certification for Marketing of Chinese Product
LIU Ben,SUN Zhi-hui,LI Yong-xue,LIU Rui,YANG Dong. Medical Equipment Quality Certification for Marketing of Chinese Product[J]. Chinese Medical Equipment Journal, 2013, 0(12): 115-116,121
Authors:LIU Ben  SUN Zhi-hui  LI Yong-xue  LIU Rui  YANG Dong
Affiliation:1. Office for Birth Control, Health Department of General Logistics Department, Beijing 100842, China; 2. Institute for Drug and Instrument Control, Health Department of General Logistics Department, Beijing 100071, China)
Abstract:The importance of quality certification for the improvement of the equipment performance and competition is described on the basis of the actuality analysis of medical equipment industry in China. The certification system in China is introduced on its significance for medical equipment quality and safety, and some related certification systems in medical equipment market are also listed. It's suggested that medical equipment be involved in all kinds of quality certifications for rapid development.
Keywords:medical equipment  certification  quality and safety
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