元宇宙医学通过 AR/VR 技术和医疗物联网（IoMT）实现数字化、智能化的医疗服务新模式，突破了传统医疗服务的时空限制，并在医疗教育、手术辅助、慢性疾病管理等方面展现出巨大潜力。 同时，元宇宙医学的发展也带来了技术依赖、法律监管不足、专业人才缺乏等挑战，尤其是在数据安全和个人隐私保护方面。 本文分析了数智医疗装备的监管要求与挑战，包括终端设备、终端软件和智能软件的监管，并探讨了全球主流市场数字医疗健康产品的监管举措，如美国FDA、欧盟MDR和中国NMPA的政策，提出企业面对未来监管挑战的策略建议，强调了合规经营的重要性，并展望了新兴技术对监管发展趋势的影响。

Metaverse in medicine forges a novel paradigm of digitized and intelligent healthcare services using AR/VR technology and the Internet of Medical Things (IoMT), transcending the spatial and temporal constraints of conventional medical practice and unveiling significant prospects in medical training, surgical support, and chronic disease management, among others. Concurrently, the ascent of metaverse in medicine poses challenges, including technology dependency, regulatory gaps, and a shortage of skilled professionals, particularly concerning data security and privacy protection. This article scrutinizes the regulatory demands and hurdles associated with digital medical devices, encompassing the oversight of hardware, software applications, and intelligent algorithms, and reviews regulatory strategies for digital health products in leading markets such as the FDA, MDR, and NMPA guidelines. In conclusion, the paper proffers strategic recommendations for businesses to navigate forthcoming regulatory obstacles, underscores the imperative of compliance management, and anticipates the influence of nascent technologies on the trajectory of regulatory evolution.