近年来,国家药监局为应对突发公共卫生事件,多次启动医疗器械应急审批工作,各级药品监督管理部门应急审批通过了体外诊断试剂、防护服、医用口罩等多种疫情防控产品,有力地支持了疫情防控工作的开展。本文详细分析了《医疗器械应急审批程序》对医疗器械应急审批的相关规定,同时概括了《医疗器械监督管理条例》《关于深化审评审批制度改革鼓励药品医疗器械创新的意见》《医疗器械附条件批准上市指导原则》等其他法律法规对医疗器械应急审批的相关要求。新冠肺炎疫情暴发后,我国医疗器械应急审批的积极开展极大地提升了医用防护产品供应水平,保障了疫情防控和救治的紧急需要。最后,本文总结了美国、日本和欧盟医疗器械应急审批的相关要求,并对我国更好地应对突发公共卫生事件、进一步满足突发情况紧急需要提出了相关建议。
<<In recent years,in response to public health emergencies,the State Drug Administration has repeatedly initiated the emergency examination and approval of medical devices,and the emergency approval of pharmaceutical supervisory and administrative departments at various levels has passed various epidemic prevention and control products,such as in vitro diagnostic reagents,protective clothing,medical masks,etc.,which are conducive to supporting the development of epidemic prevention and control work. This paper analyzes in details the relevant provisions of the Emergency Approval Procedures for Medical Devices on Medical Devices,and summarizes the relevant requirements of other laws and regulations on the Emergency Approval of Medical Devices,such as the Regulations on the Supervision and Administration of Medical Devices on Deepening the Reform of the Approval and Approval System for Approval of Medical Devices to Encourage the Innovation of Medical Devices. After the outbreak of COVID-19 pneumonia,the emergency examination and approval of medical devices in China has greatly promoted the supply of medical protective products,and ensured the urgent need of prevention,control and treatment of the epidemic situation. Finally,this paper summarizes the requirements of medical equipment emergency examination and approval in the United States,Japan and the European Union,and puts forward some suggestions for China to better cope with public health emergencies and further meet emergency needs.
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