[Analysis of Quality Status of National Medical Device Supervision and Inspection from 2013 to 2016].
作者信息
Zhang Xintao, Hao Qing, Shi Xian, Zhu Jiong, Luo Qingxiang, Zhang Qingsheng, Cheng Shuanghong
机构信息
National Institute for Food and Drug Control, Beijing, 100050.
Guangdong Province Medical Devices Quality Surveillance and Test Institute, Guangzhou, 510663.
出版信息
Zhongguo Yi Liao Qi Xie Za Zhi. 2017 May 30;41(3):216-219. doi: 10.3969/j.issn.1671-7104.2017.03.016.
In this paper, we analyze the status of the medical device testing and the situation of the unqualifie varieties by sorting out the situation of the national medical device supervision and inspection from 2013 to 2016. We analyze the results of the inspection deeply, and find that the safety risk points exists in the quality of the medical device testing products and management system, product technology requirements, the national standards, industry standards or other aspects, then explain one by one with typical examples. At the same time the corresponding suggestions are put forward to production companies and regulators respectively on the existing problems.
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