您好,欢迎来到皮书数据库!
热点推荐: 双循环
更多>> 课题组动态
更多>> 皮书作者
谢伏瞻
    中国社会科学院学部委员,学部主席团主席,研究员,博士生导师。历任中国社会科学院院长、党组书记,国务院发展中心副主... 详情>>
蔡 昉
    中国社会科学院国家高端智库首席专家,学部委员,学部主席团秘书长,研究员,博士生导师。先后毕业于中国人民大学、中国... 详情>>
李培林
    男,汉族,出生于1955年5月,山东济南人,博士,研究员,全国人民代表大会社会建设委员会副主任委员,中国社会科学... 详情>>

    2020年新冠肺炎疫情下我国医疗器械产品上市审批情况分析

    摘要

    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。

    <<
    >>

    Abstract

    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.

    <<
    >>
    作者简介
    毛志平:毛志平,江西三鑫医疗科技股份有限公司董事、总经理,经济师。
    彭玲:彭玲,江西三鑫医疗科技股份有限公司副总经理。
    刘炳荣:刘炳荣,江西三鑫医疗科技股份有限公司法规事务总监,工程师。
    <<
    >>
    相关报告