Risk Management to Shanghai Medical Device Registrants / 中国医疗器械杂志
Chinese Journal of Medical Instrumentation
;
(6): 444-445, 2018.
Article
in Chinese
| WPRIM
| ID: wpr-775533
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.
Full text:
Available
Index:
WPRIM (Western Pacific)
Main subject:
Risk Management
/
China
/
Registries
/
Equipment and Supplies
Type of study:
Etiology study
Country/Region as subject:
Asia
Language:
Chinese
Journal:
Chinese Journal of Medical Instrumentation
Year:
2018
Type:
Article
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