国内外定制式增材制造医疗器械监管法规概述及对行业发展的思考

Overview of domestic and foreign regulatory regulations about customized additive manufacturing medical devices and considerations of the industry development

目的概述国内外定制式增材制造医疗器械监管法规,分析医疗器械监管科学研究对增材制造医疗器械行业发展的意义,以期能够为生产企业及监管机构未来的工作提供参考。方法该文通过对国内外关于定制式增材制造医疗器械监管法规及注册体系进行分析,剖析定制式增材制造医疗器械监管法规及注册体系的创新发展对于我国医疗器械行业发展的拉动效应。结果美国、欧盟、澳大利亚、加拿大、中国均已建立定制式增材制造医疗器械监管法规及注册体系,给出了定制式医疗器械的定义,明确了定制式医疗器械临床使用和上市后监管的要求,但各国间还存在一定的差异,使得各国对于定制式医疗器械的监管模式也稍有差异,建立医疗器械科学监管模式将推动增材制造医疗器械行业发展。结论构建基于精准风险控制的评价监管体系,加强监管人员、审评人员与科研、医疗人员间的相互协同作用将有助于定制式增材制造医疗器械科学监管模式的构建。

Objective In order to provide some references for the future work of manufacturers and regulatory institutions,this article summarizes the regulations and registration system of customized additive manufacturing medical device at home and abroad,meanwhile,analyzes the significance of medical device regulation science on the development of medical device industry.Methods This paper analyzed the regulations and registration system of customized additive manufacturingmedical device at home and abroad,as well as the driving effect of the innovative development of the regulatory regulations and registration system of customized additive manufacturing medical devices on the development of China's medical device industry.Results The regulations and registration system of customized additive manufacturing medical device all have been build in the US,EU,Australia,Canada and China.The definition of customized medical device has been given,and the requirements about the customized medical devices for clinical use and post-marketing surveillance have been clear out,but there were some differences between these countries,leading to the different in regulatory model of the customized medical devices.Establishing scientific regulatory model will promote the development of additive manufacturing medical device industry.Conclusion The establishment of an evaluation and supervision system based on accurate risk control and strengthening the interaction between supervisors,reviewers,researchers and medical personnel will contribute to the construction of a scientific supervision model of customized additive manufacturing medical devices.