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Abstract: medical devices are instruments and other tools that act on the human body to aid clinical diagnosis and disease treatment, playing an indispensable role in modern medicine. Nowadays, the increasing demand for personalized medical devices poses a significant challenge to traditional manufacturing methods. The emerging manufacturing technology of three-dimensional (3D) printing as an alternative has shown exciting applications in the medical field and is an ideal method for manufacturing such personalized medical devices with complex structures. However, the application of this new technology has also brought new risks to medical devices, making 3D-printed devices face severe challenges due to insufficient regulation and the lack of standards to provide guidance to the industry. This review aims to summarize the current regulatory landscape and existing research on the standardization of 3D-printed medical devices in China, and provide ideas to address these challenges. We focus on the aspects concerned by the regulatory authorities in 3D-printed medical devices, highlighting the quality system of such devices, and discuss the guidelines that manufacturers should follow, as well as the current limitations and the feasible path of regulation and standardization work based on this perspective. The key points of the whole process quality control, performance evaluation methods and the concept of whole life cycle management of 3D-printed medical devices are emphasized. Furthermore, the significance of regulation and standardization is pointed out. Finally, aspects worthy of attention and future perspectives in this field are discussed.

药检院韩倩倩及浙大贺永等 | 3D打印医疗器械的个性化与标准化：中国的监管探索与实践

本综述论文聚焦中国对3D打印医疗器械的监管和标准化研究现状及挑战。医疗器械是指直接或者间接用于人体的仪器、设备、器具、体外诊断试剂及校准物、材料以及其他类似或者相关的物品，其本身就融合了医学、机械、电子、计算机等多学科交叉的概念。在医工交叉领域，3D打印技术在医疗器械研发和制造方面的应用，不断为医疗器械的创新发展赋能，形成了“3D打印医疗器械”产品，并在近5年逐步得以广泛应用。3D打印医疗器械主要使用金属、聚合物等材料，可实现器械的个性化定制和精密微观结构的制造。然而，3D打印带来“个性化”的同时也带来了独有的风险，传统对于标准化产品的监管方式可能难以适用，同时对3D打印医疗器械的工艺、质量和风险也缺乏分析和评价方法及标准，使3D打印医疗器械的监管面临诸多挑战。

针对3D打印医疗器械“个性化”与“标准化”的矛盾，本文重点梳理和分析了：（1）监管部门对3D打印医疗器械关注的方面；（2）3D打印医疗器械的质量控制体系；（3）3D打印医疗器械的标准化和监管的未来发展。从监管部门的角度和风险控制的角度对这一新兴领域的规范发展进行关键点设计，对行业、政策和标准的方向进行分析和布局，同时也为医疗器械企业更好地利用3D打印技术并满足监管要求提供指南。

（浙江大学机械工程学院硕士生金钟博宇为本文第一作者；中国食品药品检定研究院（医用增材制造技术医疗器械标准技术归口单位）的韩倩倩研究员和浙江大学贺永教授为共同通讯作者）