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The Policy and Practice of Medical Device Emergency Approval at the Local Level under the Circumstance of COVID-19 Disease / 中国医疗器械杂志
Chinese Journal of Medical Instrumentation ; (6): 429-433, 2021.
Article Dans Chinois | WPRIM | ID: wpr-888639
ABSTRACT
This research analyzed Chinese emergency approval policies and practices of medical devices at the local level under the circumstance of COVID-19 disease. The legal basis and administrative system were clarified, the implementation and characteristics of emergency approval policies were investigated, the products information including total approved number, product type and license's validity period were counted. Advices as enhancing the standardization of emergency approval system, strengthening registration guidance and optimize information disclose and management were provided.
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Texte intégral: Disponible Indice: WPRIM (Pacifique occidental) Sujet Principal: Agrément de dispositif / Politique (principe) / SARS-CoV-2 / COVID-19 Type d'étude: Guide de pratique / Étude pronostique Limites du sujet: Humains langue: Chinois Texte intégral: Chinese Journal of Medical Instrumentation Année: 2021 Type: Article

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Texte intégral: Disponible Indice: WPRIM (Pacifique occidental) Sujet Principal: Agrément de dispositif / Politique (principe) / SARS-CoV-2 / COVID-19 Type d'étude: Guide de pratique / Étude pronostique Limites du sujet: Humains langue: Chinois Texte intégral: Chinese Journal of Medical Instrumentation Année: 2021 Type: Article