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Analysis of Factors Affecting Effectiveness of Medical Device Registration Self-inspection from Perspective of Technical Evaluation / 中国医疗器械杂志
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.
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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
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