3D打印定制式医疗器械技术审评及监管现状分析思考

Analysis of Technical Evaluation for Current Regulation of 3D Printed Customized Medical Device

摘要: 该文分析总结了目前美国、欧盟针对3D打印定制式医疗器械法律法规的研究现状。根据美国、欧盟对3D打印定制式医疗器械产品的探讨，从设计、生产制造、检测等环节提出了思考和初步解决方法。

Abstract: This paper summarizes the current research status of 3D printed customized medical devices regulations in US and EU. Based on the discussion of 3D printed customized medical devices in the US and the European Union, some thoughts are put forward from design, manufacturing, testing and other aspects.