Analysis of Factors Affecting Effectiveness of Medical Device Registration Self-inspection from Perspective of Technical Evaluation / 中国医疗器械杂志
Chinese Journal of Medical Instrumentation
; (6): 680-683, 2023.
Article
em Zh
| WPRIM
| ID: wpr-1010261
Biblioteca responsável:
WPRO
ABSTRACT
Type inspection is a necessary precondition of technical evaluation of medical device. The implementation of The Provisions for Administration of Self-Test for Medical Device Registration facilitates the registration pathway for applicants. How to improve the effectiveness of registration self-test has drawn attention from many stakeholders. In this study, we analyzed and discussed the factors affecting the validity of registration self-test from technical evaluation perspective, and proposed suggestions for improvement accordingly. The aim of this article is to boost the reliability and effectiveness of registration self-test and offer a reference for applicants to carry out registration self-test.
Palavras-chave
Texto completo:
1
Índice:
WPRIM
Assunto principal:
Legislação de Dispositivos Médicos
Idioma:
Zh
Revista:
Chinese Journal of Medical Instrumentation
Ano de publicação:
2023
Tipo de documento:
Article