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
em Zh
| WPRIM
| ID: wpr-775533
Biblioteca responsável:
WPRO
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.
Palavras-chave
Texto completo:
1
Índice:
WPRIM
Assunto principal:
Gestão de Riscos
/
China
/
Sistema de Registros
/
Equipamentos e Provisões
Tipo de estudo:
Etiology_studies
País/Região como assunto:
Asia
Idioma:
Zh
Revista:
Chinese Journal of Medical Instrumentation
Ano de publicação:
2018
Tipo de documento:
Article