Concerns of Technical Evaluation on Registration of Disposable Endoscopic Injection Needle / 中国医疗器械杂志
Chinese Journal of Medical Instrumentation
; (6): 317-319, 2023.
Article
em Zh
| WPRIM
| ID: wpr-982236
Biblioteca responsável:
WPRO
ABSTRACT
From the point of the technical evaluation of the registration of medical devices, the technical evaluation focus of the disposable endoscopic injection needle registration are briefly described in the chapters of the application overview documents, risk management data, product technical requirements, research data, toxic substance residues, biocompatibility evaluation, clinical evaluation data, et al. The common terms of technical requirements are specified, risk management and research materials list the project requirements for product characteristics. So as to accurately judge the product quality, improve the review efficiency, promote the development of the industry.
Palavras-chave
Texto completo:
1
Índice:
WPRIM
Assunto principal:
Gestão de Riscos
/
Endoscopia
/
Indústrias
/
Injeções
/
Agulhas
Idioma:
Zh
Revista:
Chinese Journal of Medical Instrumentation
Ano de publicação:
2023
Tipo de documento:
Article