Risk Point Analysis of Product Quality and Safety in Sample Inspection of National Medical Device Supervision.
10.3969/j.issn.1671-7104.2019.03.014
- Author:
Qing HAO
1
;
Xintao ZHANG
1
;
Jiong ZHU
1
;
Xian SHI
1
;
Xiao LI
1
;
Ning ZHU
2
Author Information
1. National Institute for Food and Drug Control, Beijing, 102600.
2. National Medical Products Administration, Beijing, 100053.
- Publication Type:Journal Article
- Keywords:
medical device;
supervision and testing;
the quality and safety risk points
- MeSH:
Equipment Safety;
Equipment and Supplies;
Industry;
Reference Standards
- From:Chinese Journal of Medical Instrumentation
2019;43(3):209-213
- CountryChina
- Language:Chinese
-
Abstract:
This paper reviews the quality and safety risk points of medical devices found in the sampling inspection of national medical device supervision in recent years. These risk points are summarized into quality management system, product technical requirements, national standards and industry standards, etc. Several specific risk scenarios are further summarized. Based on the above efforts, a more comprehensive risk point system is constructed. Then it is illustrated with typical examples. In view of the existing problems, the corresponding suggestions are put forward to the production enterprises and supervision departments respectively.
