国产乙类大型医用设备注册现状研究

Research on the Registration Status of Domestic Class B Large Medical Equipment

大型医用设备管理目录放宽和规划提量有助于推动高端医用设备市场扩容、加速国产大型医用设备替代进口产品的进程。由于医疗机构对国产大型医用设备注册现状和产品情况的研究不足,在配置大型医用设备时较少考虑国产设备。该文基于国家药品监督管理局官网的国产乙类大型医用设备注册证信息,采用数据去重和分类等方法定量分析国产乙类大型医用设备注册量趋势和生产企业分布等情况。结果表明,近几年国产乙类大型医用设备行业发展较快,不断突破进口产品垄断的局面和高精尖技术壁垒,态势良好。该文可帮助大型医用设备配置许可相关管理人员及医疗机构医疗设备管理人员深入了解国产乙类大型医用设备现状,为大型医用设备配置工作提供参考。

The relaxation of the management catalogue of large medical equipment and the increase in the number of plans will help promote the expansion of the high-end medical equipment market and accelerate the process of replacing imported products with domestic large medical equipment.In view of the lack of research on the registration status and product situation of domestic class B large medical equipment,and medical institutions rarely consider domestic equipment when configuring large medical equipment,this paper analyzes the registration certificate information of domestic class B large medical equipment on the official website of the State Drug Administration,and uses data deduplication and classification methods to quantitatively analyze the registration trend of domestic class B large medical equipment and the distribution of manufacturers.The results show that in recent years,the domestic class B large medical equipment industry has developed rapidly,and it has continuously broken through the monopoly of imported products and high-precision technical barriers,and the situation is good.This paper can help the relevant management personnel of high technology medical equipment configuration license and the medical equipment management personnel of medical institutions to have an in-depth understanding of the current situation of domestic class B large medical equipment,and provide reference for the configuration of large medical equipment.