Discussion of Enlightenment from the Reorganization of CDRH Regulatory for Medical Device / 中国医疗器械杂志
Chinese Journal of Medical Instrumentation
;
(6): 154-157, 2020.
Artigo
em Chinês
| WPRIM
| ID: wpr-942718
ABSTRACT
This study introduces the establishment and the situation before and after the reorganization of Center for Devices and Radiological Health (CDRH). Meanwhile, it sorted out the important changes in this reorganization of CDRH. CDRH optimizes regulatory decisions by integrating pre-marketing and post-marketing professionals for the total product lifecycle of medical devices, based on product line guidelines. Taking the sutatus of Chinese medical device supervision into consideration, this study put forward some thoughts on scientific supervision.
Texto completo:
DisponíveL
Índice:
WPRIM (Pacífico Ocidental)
Assunto principal:
Estados Unidos
/
United States Food and Drug Administration
/
Aprovação de Equipamentos
/
Marketing
País/Região como assunto:
América do Norte
Idioma:
Chinês
Revista:
Chinese Journal of Medical Instrumentation
Ano de publicação:
2020
Tipo de documento:
Artigo
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