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    2019年广东省医疗器械行业发展状况与展望

    摘要

    广东省医疗器械产业具有区域性、聚集性、集中性分布的特点,医疗器械生产企业、生产产品数量稳定快速增长,产品类别日趋完善,龙头企业集聚效应得以发挥。产业政策方面,广东省扎实推进医疗器械注册人制度试点工作,大力鼓励医疗器械创新产品研发,加快推进粤港澳大湾区创新机制,多部门协作推出医疗器械创新政策;监管方面,广东省药监局扎实推进审评审批制度改革,不断强化事中事后监管力度,建立了涵盖医疗器械研制、生产、经营、使用、不良事件监测和再评价的全生命周期监管体系,为保障公众用械安全和促进产业健康发展发挥了重要作用。但广东省医疗器械行业也存在一些问题,如企业运营成本居高不下,产业链配套存在短板;基础研究相对薄弱,缺少尖端核心技术,高端医疗器械研发创新不足;等等。

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    Abstract

    The medical device industry of Guangdong Province has the characteristics of regional,agglomeration and centralized distribution,the medical device production enterprises and the production products quantity is stable and rapid growth,the product category is becoming more perfect,the leading enterprise agglomeration effect can be brought into full play;At the same time,Guangdong Province has made solid efforts to promote the trial work of the medical device registrant system,vigorously encourage the innovation mechanism of medical device products,accelerate the development of the medical device innovation policy of the large bay area,and cooperation with various departments,promote the development of medical device production;in the supervision and supervision and supervision;in the reform of the reform of the system;in the system;in the supervision and supervision of the system;in the development of the reform of the system;in the supervision of medical devices;in the reform of medical device inspection system;in the reform of medical device inspection and examination examination and examination and approval. However,there are also some problems in the medical equipment industry in Guangdong Province,such as high operating cost,shortage of industrial chain support,weak basic research,lack of high-end core technology,lack of high-end medical equipment R&D innovation,and so on.

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    作者简介
    张锋:张锋,广东省药品监督管理局医疗器械监督管理处处长、讲师。
    张扬:张扬,广东省药品监督管理局医疗器械监督管理处主任科员。
    刘舜莉:刘舜莉,广东省医疗器械管理学会秘书长。
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