摘要
随着增材制造髋臼重建植入器械在治疗髋臼缺损和重建中的优势逐渐凸显,该类产品注册申报量日益增多。根据国家药品监督管理局对注册申报资料的相关要求,结合增材制造髋臼重建植入器械产品特点,对申请人提交的注册申报资料需重点关注的原材料控制、产品性能研究、产品生产制造、临床评价等方面的相关要求进行了分析总结。对下一步注册申请人规范产品研发和注册申报资料提供意见和建议,帮助其优化产品研发流程,提升产品质量,提高注册申报效率。
With the development of additive manufacturing,the advantages of this type implant devices in the treatment of acetabular defects and reconstruction are becoming more and more prominent.The number of registration and declaration of such products is increasing day by day.According to the relevant requirements of the National Medical Products Administration for registration and application documents,combined with the characteristics of acetabular reconstruction implant products made of additive manufacturing,this study analyzes and summarizes the relevant requirements on raw material control,product performance research,product manufacturing,clinical evaluation,et al.We should pay more attention to in the registration and application materials submitted by the applicant.Provide opinions and suggestions for the next registration applicant to standardize product R&D and registration application documents,in order to help them optimize product R&D process,improve product quality and registration application efficiency.
作者
张家振
翟豹
阿茹罕
闵玥
郭亚娟
史新立
ZHANG Jiazhen;ZHAI Bao;A Ruhan;MIN Yue;GUO Yajuan;SHI Xinli(Center for Medical Device Evaluation,National Medical Products Administration,Beijing,100081)
出处
《中国医疗器械杂志》
2022年第6期659-663,共5页
Chinese Journal of Medical Instrumentation
关键词
增材制造
髋臼重建植入器械
技术审评
质量保证
additive manufacturing
acetabular reconstruction implantable device
technical review
quality assurance
