A Brief Discussion on the in Vitro Diagnostic Reagent Inspection Practice of Self-examination Management Regulations for Medical Device Registration / 中国医疗器械杂志
Chinese Journal of Medical Instrumentation
;
(6): 324-327, 2023.
Artigo
em Chinês
| WPRIM
| ID: wpr-982238
ABSTRACT
On October 21, 2021, the National Medical Products Administration issued and implemented the Self-examination Management Regulations for Medical Device Registration. The regulations clarify the specific requirements of the registration applicants in the process of self-examination, and put forward detailed requirements from the aspects of self-examination ability, self-examination report, declaration materials and responsibility requirements, so as to ensure the orderly development of the self-examination of medical device registration. Based on the actual verification work of in vitro diagnostic reagent, this study briefly discussed the understanding of the relevant contents of the regulations, aiming to provide some reference for enterprises and related supervision departments that have the requirement of registered self-examination.
Texto completo:
DisponíveL
Índice:
WPRIM (Pacífico Ocidental)
Assunto principal:
Kit de Reagentes para Diagnóstico
/
Legislação de Dispositivos Médicos
Idioma:
Chinês
Revista:
Chinese Journal of Medical Instrumentation
Ano de publicação:
2023
Tipo de documento:
Artigo
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