美国医疗器械认可共识标准管理体系研究  

Research on the Management System of Medical Device Recognized Consensus Standards in USA

作　　者：郑佳[1] 易力 李静莉[1] ZHENG Jia;YI Li;LI Jingli(Institute for Medical Device Standardization Administration,National Institutes for Food and Drug Control,Beijing,102629)

机构地区：[1]中国食品药品检定研究院医疗器械标准管理研究所,北京市102629

出　　处：《中国医疗器械杂志》2018年第2期119-121,132,共4页Chinese Journal of Medical Instrumentation

摘　　要：该文简要介绍了美国医疗器械认可共识标准的发展历程、认可工作程序以及认可共识标准清单的基本情况,初步分析了美国医疗器械认可共识标准管理体系的经验,为完善我国医疗器械标准管理体系提供借鉴和参考。This paper gives a brief introduction on the development of recognized consensus standards,the recognition working procedure and the overview of medical devices recognized consensus standards in USA,and analyzes the experience of the recognition management system in USA,aiming at providing a reference for the improvement of the medical device standard management system in China.

关 键 词：美国 医疗器械 共识标准 

分 类 号：F203[经济管理—国民经济]