摘要
我国已初步建立了由法规体系、标准体系、导则体系及产品体系共同构成的医用增材制造监管体系。通过对医用材制造监管研究项目的监管理念进行分析,剖析我国医用增材制造监管体系的建设思路,梳理监管成果。概述我国医用增材制造监管体系的建设过程及成果,分析监管体系对促进产业创新发展的意义,以期能够为医用增材制造产品转化和科学监管提供参考。监管体系建设的核心在于制度创新,实现监管制度和产业发展相伴行,依托关键技术联合攻关的新型举国机制,通过产-学-研-医-检-政协同合作,将不断丰富医用增材制造技术监管体系内涵,建立医用增材制造产品转化的高速便捷路径。
China has initially established medical additive manufacturing supervision system composed of legal system,standard system,guideline system and product system.Through the analysis of the supervision concept of the research project of medical additive manufacturing supervision,this paper analyzes the construction ideas of medical additive manufacturing supervision system and sorts out the supervision results.To summarize the construction process and achievements of the supervision system of medical additive manufacturing in China,and analyze the significance of the supervision system to promote industrial innovation and development,in order to provide reference for the transformation and scientific supervision of medical additive manufacturing products.The core of the supervision system construction lies in institutional innovation,and the supervision system and industrial development are accompanied.Relying on the new national mechanism of joint research on key technologies,through the cooperation of industry-university-research-medical-inspection-political consultation,the connotation of the supervision system of medical additive manufacturing technology will be continuously enriched,and a high-speed and convenient path for the transformation of medical additive manufacturing products will be established.
作者
高进涛
刘斌
韩丹
丁金聚
GAO Jin-tao;LIU Bin;HAN Dan;DING Jin-ju(GBA Center for Medical Device Evaluation and Inspection,NMPA,Guangdong Shenzhen 518045)
出处
《中国医疗器械信息》
2023年第21期1-5,35,共6页
China Medical Device Information
关键词
医用增材制造
监管体系
科学监管
转化
medical additive manufacturing
supervision system
scientific supervision
transformation
作者简介
第一作者:高进涛,硕士,工程师,研究方向:骨科医疗器械;通信作者:丁金聚,高级工程师,研究方向:骨科医疗器械。
