美国医疗器械重新分类工作机制探析  

Analysis on Re-classification Management Procedure of Medical Devices in the United States

作　　者：王越[1] 张春青[1] 郑佳[1] 郭世富[1] 母瑞红[1] 余新华[1] WANG Yue;ZHANG Chunqing;ZHENG Jia;GUO Shifu;MU Ruihong;YU Xinhua(National Institute for Food and Drug Control, Beijing, 100050)

机构地区：[1]中国食品药品检定研究院

出　　处：《中国医疗器械杂志》2019年第2期118-121,共4页Chinese Journal of Medical Instrumentation

摘　　要：该文深入分析了美国FDA医疗器械产品重新分类工作机制,以及近年来启动的对已上市高风险产品的全面评估、高风险产品的降类工作情况。在对美国医疗器械产品分类工作机制和监管思路分析基础上,综合考虑中国医疗器械分类工作现状,对我国分类工作模式提出建议,为提升我国医疗器械分类管理工作质量和效率提供参考。A detailed analysis on re-classification procedure of medical devices from Food and Drug Administration. The experience on classification procedures, the work-flow of risk reanalysis and regulatory categories reassessment of listed products, as well as launching a comprehensive evaluation and downgrading of listed high-risk products were explored in recent years. Based on the analysis on classification procedures and supervision of medical device products in the USA, and combined with the current situation of classification of medical devices in China, some suggestions were put forward on the current classification mode of medical devices so as to improve the quality and efficiency of classified management of medical devices in China.

关 键 词：医疗器械 分类 工作机制 动态管理 

分 类 号：F203[经济管理—国民经济] R951[医药卫生—药学]