Risk Management to Shanghai Medical Device Registrants.
10.3969/j.issn.1671-7104.2018.06.015
- Author:
Minliang ZHOU
1
;
Ming MENG
1
Author Information
1. Certification and Evaluation Center of SHFDA, Shanghai, 200020.
- Publication Type:Journal Article
- Keywords:
medical device;
registrant;
risk management
- MeSH:
China;
Equipment and Supplies;
Registries;
Risk Management
- From:
Chinese Journal of Medical Instrumentation
2018;42(6):444-445
- CountryChina
- Language:Chinese
-
Abstract:
In Nov.2017, Shanghai CFDA began to pilot medical device registrant project in China. This project is a bold attempt to medical device supervision. And it's quite helpful for promoting innovation and development of medical devices in Shanghai. However, the "R&D-Production-separate" characteristic enhances risks in medical device life-cycle. It also brings more challenges to registrant on medical device risk management. In order to protect interested parties fully and effectively, we will discuss why registrants need to manage risk and what they should pay attention to in this article.
