支持高端医疗器械发展十大举措将发布，2030年市场规模预计达2.8万亿

Core Viewpoint - The National Medical Products Administration (NMPA) has approved measures to optimize the lifecycle regulation supporting the innovation of high-end medical devices, which is expected to significantly benefit related companies by establishing a faster and updated review and approval mechanism in this field [1][5][11]. Group 1: Key Measures of the Initiative - The initiative includes ten specific measures such as optimizing special approval procedures, improving classification and naming principles, and enhancing post-market supervision requirements [2][6]. - It emphasizes the importance of a risk-based response mechanism for high-risk products, such as brain-computer interfaces and AI surgical robots, which will require proactive monitoring and annual safety update reports [5][7]. Group 2: Market Potential and Growth - The global high-end medical device market is projected to exceed $1.8 trillion by 2030, with China's market expected to reach 2.8 trillion yuan [5][6]. - The increasing public focus on health is driving rapid expansion in the demand for high-end medical devices [5]. Group 3: Regulatory Focus and Quality Monitoring - The initiative highlights the need for stringent post-market regulatory requirements and quality testing for high-end medical devices, ensuring their efficacy, safety, and economic viability [7][11]. - A special quality evidence framework is proposed for devices like surgical robots, which includes monitoring functional changes and operational efficiency [7][11]. Group 4: Recommendations for Companies - Companies are advised to establish a comprehensive "evidence chain" for the lifecycle cost-effectiveness of their products, focusing on clinical and economic value indicators [8][9]. - It is recommended that companies innovate payment models to enhance market penetration and clearly communicate the advantages of high-end medical devices over traditional ones [9][10]. Group 5: Importance of Compliance and Research - Companies should prioritize foundational research in technology to create a competitive edge in high-end medical device innovation while ensuring compliance with regulatory standards [12]. - The initiative also stresses the need for improved data collection standards and performance evaluation for AI medical devices, which are crucial for sustainable industry development [12].