我国创新医疗器械特别审查情况分析  

Analysis of the Special Review of Innovative Medical Devices in China

作　　者：赵娜娜 李雪娇 Zhao Nana;Li Xuejiao(Center for Medical Device Evaluation.NMPA,Beijing 100076,China)

机构地区：[1]国家药品监督管理局医疗器械技术审评中心,北京100076

出　　处：《中国药事》2025年第3期300-305,共6页Chinese Pharmaceutical Affairs

摘　　要：目的:分析国家药品监督管理局医疗器械技术审评中心官网于2014年-2024年8月发布的创新医疗器械公示数据,供医药界同仁参考。方法:通过对2014年以来创新医疗器械的申报通过率、地区分布、种类分布等情况进行梳理分析,剖析其变化趋势,从审查视角分析常见问题并提出有关建议。结果:发现共535个医疗器械获准进入创新审查程序,通过率为19.25%。纳入创新通道的医疗器械以有源类、无源类产品居多,产品多集中于技术含量高、临床需求迫切的高端领域,申请人多集中在北京、上海、广东、江苏、浙江5个地区。立卷审查环节常见问题主要集中在申请表、发明专利、研发资料方面,专家审查环节每个审查要求方面都存在着诸多问题。结论:建议企业注重注册人员的培养并加强对相关法规的学习;监管部门加强各单位的通力合作,并做好评审专家及申请人的相关培训工作。Objective:To analyze the public disclosure data of innovative medical devices released on the official website of the CMDE from 2014 to August 2024,and to provide reference for colleagues in the medical industry.Methods:Through combing and analyzing the application pass rate,regional distribution and type distribution since 2014,the change trend and common problems were analyzed from the perspective of review,as well as relevant suggestions were put forward.Results:It was found that a total of 535 medical devices were approved into the innovation review process,with a pass rate of 19.25%.Most of the medical devices included in the innovation channel are active and passive products,which are mostly concentrated in the highend fields with high technical content and urgent clinical needs,most of the applicants are concentrated in Beijing,Shanghai,Guangdong,Jiangsu,Zhejiang 5 regions.The common problems in the volume review process mainly focus on the application form,invention patent,and research and development data.There are many problems in each review requirement in the expert review process.Conclusion:It is suggested that enterprises should pay attention to the training of registered personnel and strengthen the study of relevant laws and regulations,and the regulatory authorities should strengthen the cooperation of all units,and do a good job in the relevant training of evaluation experts and applicants.

关 键 词：创新医疗器械 特别审查 立卷审查 专家审查 

分 类 号：R95[医药卫生—药学]