1.
Zhongguo Yi Liao Qi Xie Za Zhi
; 41(3): 216-219, 2017 May 30.
Article
in Chinese
| MEDLINE
| ID: mdl-29862772
ABSTRACT
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.