摘要
概述3D打印口腔修复用的医疗器械研发进程和注册要求,鼓励相关从业者更多地应用3D打印技术进行器械研发和注册,为临床医生和口腔患者提供更多和更优的选择。
By reviewing the development process and registration requirements of 3D printed medical devices for prosthodontics,this paper encourages practitioners to make more use of 3D printing for device development and registration,so as to provide more and better choices for clinicians and oral patients.
作者
仉琪
李耀华
ZHANG Qi;LI Yao-hua(Center for Medical Device Evaluation of NMPA,Beijing 100081)
出处
《中国医疗器械信息》
2021年第17期1-2,139,共3页
China Medical Device Information
基金
国家重点研发计划资助(项目编号:2018YFB1106900)。
关键词
3D打印
口腔修复
器械注册
3D printing
prosthodontics
medical devices registration