SIASUN(SZ:300024) news flash·2025-07-03 10:13Core Viewpoint - The National Medical Products Administration (NMPA) is accelerating the establishment of quality management system inspection points for high-end medical products, including surgical robots and recombinant collagen, to support the innovation and development of high-end medical devices [1] Group 1: Regulatory Measures - The NMPA has announced measures to optimize the lifecycle supervision of high-end medical devices, focusing on innovative products [1] - Regulatory discussions will be held for representative innovative medical devices, guiding local supervision in provinces with concentrated innovation [1] - The NMPA aims to analyze innovation points and risk points, and develop targeted regulatory measures [1] Group 2: Quality Management System - The NMPA is expediting the formulation of inspection points for quality management systems for various innovative products, including carbon ion/proton therapy systems and animal-derived artificial heart valves [1] - High-end products such as surgical robots, AI medical devices, and recombinant collagen will also have specific quality management system inspection points established [1] Group 3: Capacity Building - The NMPA plans to strengthen the selection and training of national-level inspectors for high-end medical devices [1] - There will be efforts to validate the quality management systems of provincial inspection agencies and enhance their capabilities [1] - The goal is to improve the quality and efficiency of inspections conducted by provincial agencies [1]