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国产医用内窥镜系列产品注册情况研究 被引量:10

Study on the Registration of Domestic Medical Endoscope Products
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摘要 微创医疗技术的快速发展带动了内窥镜市场的迅速增长,但针对国产医用内窥镜产业现状的研究不足,无法提供科学、全面的产业评估。本文通过分析国家食品药品监督总局国产器械数据库的国产内窥镜相关产品注册证信息,采用数据去重、整理、分类分析等方法定量分析了国产内窥镜及相关产品种类、产品注册、企业分布等情况。结果显示,国产医用内窥镜整体行业发展迅速,态势良好;内窥镜及配套医疗器械协同发展效应明显;生产企业数量多,但集中度高。本文能帮助内窥镜行业从业人员及医疗机构医疗设备管理人员详细了解国产内窥镜产品情况,促进国产医疗器械,特别是医用内窥镜的推广。 The rapid development of minimally invasive medical technology has led to the rapid growth of endoscopy market. However, the research on the status of domestic medical endoscopy industry is insufficient to provide a scientific and comprehensive industrial evaluation. This paper analyzed the registration certificate of endoscopy related products acquired from the domestic equipment database of the state administration of food and drug administration, quantitatively analyzed the types of products, registration certificated and companied by means of data de-duplication, sorting and classification. The results showed that the development of the whole industry was rapidly, the synergistic development effect was obvious, and the number of manufacturing companies was large, but highly concentrated. This paper can help practitioners and medical equipment managers to better understand the situation of domestic endoscope products, and promote the promotion of domestic medical instruments, especially medical endoscopes.
作者 孙静 冯靖祎 郑骏 吕颖莹 王吉鸣 张倩 SUN Jing;FENG Jingyi;ZHENG Jun;LV Yingying;WANG Jiming;ZHANG Qian(Department of Clinical Engineering and Supplies,The First Affiliated Hospital,College of Medicine,Zhejiang University,Hangzhou Zhejiang 310003,China)
出处 《中国医疗设备》 2020年第1期10-12,29,共4页 China Medical Devices
基金 国家“十三五”重点研发计划项目(2017YFC0114107 2017YFC0113505 2017YFC0114106)
关键词 内窥镜 产品注册证 医疗设备国产化 医疗设备产业发展 endoscope product registration certificate localization of medical equipment medical equipment industry development
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