新冠肺炎疫情的发生,为我国医疗器械行业的发展带来了巨大的挑战,同时也带来了发展机遇。在对新冠肺炎疫情的防控过程中,医疗器械发挥了至关重要的作用。在此背景下,本文分析了我国医疗器械应急审批政策在疫情防控中的重要作用,主要阐述了应急审批政策对口罩、医用防护服、呼吸机、检测试剂等紧缺防控物资供应的应急保障作用,并对相关医疗器械和企业的生产与发展现状进行了分析与总结。疫情防控过程中,相关物资紧缺暴露出我国应急审批政策仍存在顶层法规不完善、省际应急审批政策的有效性和范围不相同等问题。疫情过后,我们应该及时总结抗击疫情的得失和完善相关制度。
<<The outbreak of COVID-19 has brought great challenges to the development of medical device industry of China,which also contains development opportunities. In the COVID-19 prevention and control process,medical devices have played a vital role. Against this background,this study analyzes the important role of medical device emergency approval policy of China in epidemic prevention and control,mainly discussing the emergency protection role of emergency approval policy on masks,medical protective clothing,ventilators,testing reagents and other scarce prevention and control materials,and the production and development status of medical devices and enterprises were analyzed and summarized. In the process of epidemic prevention and control,the shortage of relevant materials reveals that there are still some problems in emergency approval policy of China,such as imperfect top-level laws and regulations,different effectiveness and scope of emergency approval policies among provinces. After the epidemic,we should summarize the gains and losses of fighting the epidemic and improve the relevant system in time.
<<Keywords: | Medical DeviceCOVID-19Emergency Approval |