中国医疗器械检验机构现状与发展  

The Current Situation and Suggestions on the Institutes for Medical Devices Test in China

作　　者：杨晓芳[1] 李晓亮[2] 母瑞红[1] 王春仁[1] 李静莉[1] 

机构地区：[1]中国食品药品检定研究院,北京市100050 [2]解放军总后勤部卫生部药品仪器检验所,北京市100071

出　　处：《中国医疗器械杂志》2014年第1期57-60,共4页Chinese Journal of Medical Instrumentation

摘　　要：该文介绍了我国医疗器械检验机构现状,全国有医疗器械检验机构53家,其中国家级医疗器械检验机构10家。医疗器械检验机构服务于政府对医疗器械的监管,在医疗器械上市前注册和上市后监督过程中发挥着技术支持作用。同时,其也是我国的医疗器械标准化工作重要的践行者。最后,提出了检验机构目前存在的问题与解决对策,以利于我国医疗器械的持续发展。This paper introduces the current status of Chinese medical device testing and inspection institutes.There are 53 such institutions, including 10 national institutions. Medical device testing and inspection institutions service in government regulation and supervision of medical devices, playing a technique support role for medical devices from registration before appear on market to monitor and supervision after listing. Meanwhile, they are important practitioners of medical devices standardization work. Final y, put forward the current problems and countermeasures of the inspection institutes in order to facilitate the sustainable development of our national medical equipment.

关 键 词：医疗器械 检验 标准 

分 类 号：F203[经济管理—国民经济]