新型冠状病毒肺炎下的地方医疗器械应急审批政策与实践

      The Policy and Practice of Medical Device Emergency Approval at the Local Level under the Circumstance of COVID-19 Disease

      • 摘要: 在新型冠状病毒肺炎疫情防控背景下,分析地方医疗器械应急审批政策与上市产品情况。梳理应急审批制度的法律基础与管理体系,分析应急审批政策措施与特点,统计应急产品数量、类型及注册证有效期等信息,提出应提高应急审批制度规范化水平,加强注册指导和合理进行信息公开等建议。

         

        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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