Preliminary Review of Relationship between Medical Device Evaluation and Quality Management System in Premarket Approval / 中国医疗器械杂志
Chinese Journal of Medical Instrumentation
;
(6): 532-536, 2020.
Artículo
en Chino
| WPRIM
| ID: wpr-880405
ABSTRACT
This paper analyzed the current reform of review and approval mechanism for medical devices and discussed the method for technical review process extending to product quality controllable direction and found the measures and suggestions to strengthen technical review for quality management system with the help with complementary relationship between the technical review and the quality management system assessment of the pre-market registration. Nowadays, because of the demand of eRPS, MAH and the amendment of regulation, the integration of technical review and quality management system is more important, necessary and scientific. Scientific and systematic evaluation should be carried out to strengthen the pre-market approval of medical devices and ensure the safety and effectiveness of medical products.
Texto completo:
Disponible
Índice:
WPRIM (Pacífico Occidental)
Asunto principal:
Proyectos de Investigación
/
Aprobación de Recursos
/
Seguridad de Equipos
Idioma:
Chino
Revista:
Chinese Journal of Medical Instrumentation
Año:
2020
Tipo del documento:
Artículo
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