Analysis of Quality Status of National Medical Device Supervision and Inspection from 2013 to 2016
10.3969/j.issn.1671-7104.2017.03.016
- VernacularTitle:2013—2016年国家医疗器械监督抽验产品质量状况分析
- Author:
Xintao ZHANG
1
;
Qing HAO
;
Xian SHI
;
Jiong ZHU
;
Qingxiang LUO
;
Qingsheng ZHANG
;
Shuanghong CHENG
Author Information
1. 中国食品药品检定研究院
- Keywords:
medical equipment;
supervision and testing;
quality status
- From:
Chinese Journal of Medical Instrumentation
2017;41(3):216-219
- CountryChina
- Language:Chinese
-
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.
