Path to establish medical device vigilance system
10.19745/j.1003-8868.2024117
- VernacularTitle:构建医疗器械警戒体系的路径探究
- Author:
Li WANG
1
;
Pei-Ming ZHANG
;
Bing XIA
;
Xin-Ru WANG
Author Information
1. 河南省药品评价中心,郑州 450008
- Keywords:
medical device vigilance system;
medical device adverse events;
risk management
- From:
Chinese Medical Equipment Journal
2024;45(6):83-86
- CountryChina
- Language:Chinese
-
Abstract:
The current situation of the medical device vigilance system was described in China,and the guiding role of risk management as the guiding ideology for constructing the system was introduced.The path of constructing the system involved in clarifying the responsible body,developing the main contents and correlating the risk information.It's pointed out that the system had to be improved in terms of regulation,management and technology.[Chinese Medical Equipment Journal,2024,45(6):83-86]
