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Risk Analysis and Countermeasures Investigating Based on Medical Device Registration Review Process / 中国医疗器械杂志
Chinese Journal of Medical Instrumentation ; (6): 334-337, 2020.
Artículo en Chino | WPRIM | ID: wpr-828192
ABSTRACT
In order to strengthen the supervision and management of medical devices, China implements pre-market registration and approval system for medical device. Technical evaluation is a key point of Chinese medical device registration management system. This study, by process-oriented, systematically sorts out the risks existing in each part of the review process. The countermeasures for risk prevention are proposed, hoping to strengthen the quality control of the whole process of review, improve the quality and efficiency of the review effectively, and ensure the various reform measures of the medical device review and approval system effectively.
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Texto completo: Disponible Índice: WPRIM (Pacífico Occidental) Asunto principal: Control de Calidad / China / Medición de Riesgo / Aprobación de Recursos Tipo de estudio: Estudio de etiología / Factores de riesgo País/Región como asunto: Asia Idioma: Chino Revista: Chinese Journal of Medical Instrumentation Año: 2020 Tipo del documento: Artículo

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Texto completo: Disponible Índice: WPRIM (Pacífico Occidental) Asunto principal: Control de Calidad / China / Medición de Riesgo / Aprobación de Recursos Tipo de estudio: Estudio de etiología / Factores de riesgo País/Región como asunto: Asia Idioma: Chino Revista: Chinese Journal of Medical Instrumentation Año: 2020 Tipo del documento: Artículo