新材料骨植入医疗器械审评方法研究及相关思考  

Research on review methods of new material orthopedic implantable medical devices and related reflections

作　　者：孙嘉怿 张家振 Sun Jiayi;Zhang Jiazhen(Center for Medical Device Evaluation,NMPA,Beijing,100081,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,北京100081

出　　处：《生物骨科材料与临床研究》2023年第5期90-93,共4页Orthopaedic Biomechanics Materials and Clinical Study

摘　　要：随着新材料在骨植入医疗器械的应用,国家药品监督管理局启动医疗器械新材料监管科学研究,寻求管理方法的突破,以期促进新材料成果转化。通过总结可降解镁金属和增材制造用聚醚醚酮等新材料骨植入医疗器械注册申报资料存在的问题,分析目前技术审评方法的局限性,为提升审评人员在新材料研究方面的专业技术水平,帮助加强申请人对医疗器械安全有效性评价的理解,提出审评方法改进建议,以期调整审评思路,提高审评效率,促进监管服务质量的提升。With the application of new materials in orthopedic implantable medical devices,NMPA launched scientific research on the supervision of new materials for medical devices,seeking breakthroughs in management methods,to accelerate the transformation process of new material achievements.By summarizing the major problems in the registration related to orthopedic implantable medical devices made of new materials such as biodegradable magnesium metal and PEEK for additive manufacturing,analyzing the limitations of the existing review methods,and making relevant suggestions to improve the review methods,to enhance the professional and technical level of reviewers in the study of new materials,to help strengthen the applicant's understanding of the safety and effectiveness evaluation of medical devices,so as to adjust the review of ideas,improve the efficiency of the review,and promote the quality of regulatory services.

关 键 词：新材料 骨植入 安全有效性 技术审评方法 

分 类 号：R318[医药卫生—生物医学工程]