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    2019年江苏省医疗器械行业发展状况及展望

    摘要

    江苏省医疗器械产业规模稳步增长,产业集聚度越来越高,产品门类比较齐全,不断利用外资借势提质,骨干企业实力不断增强,区域特色布局逐渐形成,综合创新能力在全国具有一定的优势。新组建的江苏省药监局,不断加强部门协作和区域合作,拓展国际交流合作空间,促进政企良性互动,加大创新探索力度,完善监管制度机制和方式方法,不断增强监管的专业性、权威性,大力促进医疗器械产业高质量发展。但江苏省医疗器械产业仍存在较多亟待解决的问题,如产业结构瓶颈亟待突破、企业创新成本相对较高、专业人才仍然存在缺口、监管支撑力量需要加强等。未来需要进一步拓宽延伸产业发展空间、加强区域协同创新发展、促进高端医疗器械研制、深化审评审批制度改革、增强监管技术支撑。

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    Abstract

    The scale of Jiangsu province medical equipment industry grows steadily,the industry agglomeration degree is higher and higher,the product category is relatively complete,unceasingly uses the foreign capital to borrow the situation to improve the quality,the backbone enterprise strength unceasingly strengthens,the regional characteristic layout is being formed,the comprehensive innovation ability has certain superiority in the whole country. The newly established Jiangsu Provincial Drug Administration has continuously strengthened departmental cooperation and regional cooperation,expanded international exchange and cooperation space,promoted benign interaction between government and enterprises,enhanced exploration and innovation,improved regulatory system mechanism and methods,continuously enhanced the professional and authoritative supervision,and vigorously promoted the high-quality development of the medical equipment industry. However,there are still many problems to be solved in Jiangsu medical equipment industry,such as the bottleneck of industrial structure,the relatively high cost of enterprise innovation,the gap of professional talents,and the need to strengthen regulatory support. In the future,it is necessary to broaden the space for extended industrial development,strengthen regional collaborative innovation and development,promote the development of high-end medical devices,deepen the reform of the examination and approval system,and strengthen the support of drug supervision technology.

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    作者简介
    王越:王越,江苏省药品监督管理局局长,主任药师。
    沈晓洁:沈晓洁,江苏省药品监督管理局常州检查分局局长,主管药师。
    顾海明:顾海明,苏州科技城科技创新服务中心主任,高级工程师。
    杨奇:杨奇,江苏省药品监督管理局主任科员。
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