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谢伏瞻
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李培林
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    2020年我国医疗器械行业政策分析报告

    摘要

    医疗器械是医药行业的重要组成部分。据中国药招联盟搜集的医药相关政策文件数据,“十三五”期间,国家和地方官方发布的医药行业相关政策文件共7666件。其中国家层面(含行业协会)发布1690件,占比22。0%,地方层面发布5976件,占比78。0%。直接涉及医疗器械行业的相关政策有1311件,其中国家层面发布374件,占比28。5%,地方层面发布937件,占比71。5%;2016~2020年分别出台135件、207件、162件、314件、493件。2020年,医疗器械行业相关政策依然以覆盖全产业链的政策为最多;按文件性质分析,通知类、细则类、通告类政策排在前三位;按三医联动分析,医药类政策文件最多;从各省(区、市)发布的数量来看,排名靠前的广东、四川、贵州、河南、湖北、湖南,共计发文126件,占比30。5%;按关键词排序,2020年排名前五位的是集中采购、注册管理、疫情特殊监管、设备配置、飞行检查。

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    Abstract

    Medical devices are an important part of the pharmaceutical industry. According to incomplete statistics,during the 13th five-year plan period,the China Pharmaceutical Recruitment Federation collected data on pharmaceutical-related policy documents. According to incomplete statistics,the number of pharmaceutical-related policy documents issued by state and local authorities totaled 7666. Of these,1690 were issued by state-level officials(including trade associations),accounting for 22.0%,while 5976 were issued by local-level officials,accounting for 78.0%. There were 1311 medical device related policies,of which 374 were issued officially at the national level,accounting for 28.5%,and 937 were issued officially at the local level,accounting for 71.5%. During the “15th Year Plan Period” from 2016 to 2020,135207,162314 and 493 were issued respectively. We predict the following five characteristics of the medical device policy in 2021:(1)the national macro-program policy to guide the current direction of reform and development of medical device industry;(2)volume purchase in the medical device industry with full swing;(3)major changes in the health insurance mechanism,with various reform measures extending to the medical device industry;(4)improving and deepening strict supervision over the life cycle of medical devices,with innovative measures in place;and(5)integrated reform of the three medical systems,constructing Health Ecology of medical instrument industry with combination boxing.

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    作者简介
    刘强:刘强,中国药招联盟政策研究员。
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