浅析个性化基台及基台冠桥产品临床评价关注点  

Brief Analysis of Clinical Evaluation Concerns of Personalized Abutments and Abutment Crown Bridge Products

作　　者：程玮璐 张译丹 吉丽 郭佳莹 张庆 刘英慧 CHENG Weilu;ZHANG Yidan;JI Li;GUO Jiaying;ZHANG Qing;LIU Yinghui(Center for Medical Device Evaluation,NMPA,Beijing,100081;GBA Center for Medical Device Evaluation and Inspection,NMPA,Shenzhen,518045;Sichuan Center for Food and Drug Evaluation,Inspection and Monitoring,Chengdu,610017;Yangtze River Delta Center of Medical Device Evaluation and Inspection of NMPA,Shanghai,201210)

机构地区：[1]国家药品监督管理局医疗器械技术审评中心,北京市100081 [2]国家药品监督管理局医疗器械技术审评检查大湾区分中心,深圳市518045 [3]四川省食品药品审查评价及安全监测中心,成都市610017 [4]国家药品监督管理局医疗器械技术审评检查长三角分中心,上海市201210

出　　处：《中国医疗器械杂志》2024年第2期217-220,共4页Chinese Journal of Medical Instrumentation

基　　金：国家重点研发计划(2018YFC1106701)。

摘　　要：目的个性化基台及基台冠桥产品申报量逐年增加,但目前对于该类产品的同品种临床评价没有明确要求,该研究主要介绍了个性化基台及基台冠桥产品的临床评价关注点,以期对该类产品的申报注册提供参考。方法通过总结个性化基台及冠桥产品的临床评价审评情况,明确其临床评价时的研究内容。结果该研究中介绍了注册申请人需要考虑的性能要求及同品种产品临床数据的具体要求。结论个性化基台及基台冠桥产品在中国境内上市时可参考本研究相关内容,主要通过体外测试研究论证等同性。Objective The applications of personalized abutments and abutment crown bridge products have increased year by year,but there is no clear requirement for clinical evaluation of the same variety of such products.This study mainly introduces the clinical evaluation concerns of personalized abutments and abutment crown bridge products,in order to provide reference for the declaration and registration of such products.Methods The clinical evaluation of personalized abutments and crown bridge products are summarized,and the research content of clinical evaluation is clarified.Results The clinical evaluation requirements that need to be considered by enterprises are introduced.Conclusion Personalized abutment and abutment crown bridge products can refer to this study when they are launched in China,mainly using in vitro performance comparison tests for equivalence verification.

关 键 词：个性化基台 基台冠桥 临床评价 

分 类 号：R78[医药卫生—口腔医学] F203[医药卫生—临床医学]