Study on the Medical Device Registration Submission Dossier Requirements in China / 中国医疗器械杂志
Chinese Journal of Medical Instrumentation
; (6): 428-432, 2022.
Article
em Zh
| WPRIM
| ID: wpr-939761
Biblioteca responsável:
WPRO
ABSTRACT
The evolution throughout the whole supervision history of Class II/III safety and effectiveness related NMPA submission dossier requirements was studied in this study, meanwhile elaborating the revolution progress of clinical evaluation domestically. The relationship between submission dossier requirements and Essential Principles of Safety and Performance of Medical Devices as well as IMDRF relevant documents was deeply analyzed and illustrated, in order to comprehensively understanding the background and future reform direction of NMPA submission dossier requirements under the background of the government's deepening reform of medical device evaluation and approval system strategy.
Palavras-chave
Texto completo:
1
Índice:
WPRIM
Assunto principal:
China
/
Aprovação de Equipamentos
Limite:
Humans
País/Região como assunto:
Asia
Idioma:
Zh
Revista:
Chinese Journal of Medical Instrumentation
Ano de publicação:
2022
Tipo de documento:
Article