各国放射治疗设备申报监管法规比较研究  

Comparative Research on Regulatory Requirements of Radiotherapy Equipment Across Countries

作　　者：孙超 俞悦 房虹 杜静婷 唐玉 SUN Chao;YU Yue;FANG Hong;DU Jingting;TANG Yu(National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing,100021)

机构地区：[1]国家癌症中心/国家肿瘤临床医学研究中心/中国医学科学院北京协和医学院肿瘤医院,北京市100021

出　　处：《中国医疗器械杂志》2025年第1期42-47,共6页Chinese Journal of Medical Instrumentation

基　　金：国家重点研发计划(2022YFC2409504);中国医学科学院医学与健康科技创新工程项目(2021-1-I2M-012);北京市卫生健康科技成果和适宜技术推广项目(BHTPP2022050)。

摘　　要：目的为制定我国放射治疗设备临床评价及监管政策奠定基础。方法全面检索并对比美国、欧盟及我国管理机构对放射治疗设备的申报监管要求,分析其共性及差异。结果在欧美地区,对于成熟的放射治疗系统,性能参数的比较是确定产品能否上市的重要依据。欧盟和我国均将临床评价报告作为医疗器械审评申报的重要内容。结论明确现有技术水平、性能及临床指标参数,建立相关技术指导原则,是推动放射治疗设备监管规范化发展的重要方向。Objective To lay a foundation for formulating clinical evaluation and regulatory policies regarding radiotherapy equipment in China.Methods Comprehensive retrieval and comparison of the regulatory requirements for radiotherapy equipment from regulatory agencies in the United States,the European Union,and China are conducted,and their similarities and differences are analyzed.Results For mature radiotherapy systems in the European and American regions,the comparison of performance parameters serves as an important basis for determining whether a product can be marketed.Both the European Union and China regard the clinical evaluation report as a crucial part of the medical device review and submission process.Conclusion Identifying clear state of the art standards,performance parameters,and clinical indicator parameters,and establishing relevant technical guidelines are important directions for promoting the standardized development of radiotherapy equipment supervision.

关 键 词：放射治疗设备 上市申报 监管法规 比较 

分 类 号：R197.39[医药卫生—卫生事业管理] TH77[医药卫生—公共卫生与预防医学]