国家药监局：制定手术机器人、康复机器人等医用机器人的分类指导原则

Core Viewpoint - The National Medical Products Administration (NMPA) has announced measures to optimize the lifecycle regulation and support the innovative development of high-end medical devices, including the establishment of classification guidelines for medical robots such as surgical and rehabilitation robots [1] Group 1: Regulatory Measures - The NMPA aims to strengthen the classification and naming guidance for relevant products to support the registration and application of high-end medical devices [1] - Guidelines for the classification of medical robots, including surgical and rehabilitation robots, will be developed to form a consensus among experts on the naming of medical robots [1] Group 2: Research and Development - The NMPA will conduct research on the management attributes and categories of new functions, technologies, and modalities of products such as medical large models, AI medical devices, synthetic biological materials, medical imaging preprocessing, and process optimization software [1] - The management categories of products will be dynamically adjusted based on the maturity of technological development [1] Group 3: Component Management - The NMPA will refine the management requirements for core components of medical robots and high-end medical imaging equipment [1]