Core Insights - The approval of innovative medical devices in China has reached a historical high, with 323 devices approved to date, reflecting a significant acceleration in regulatory innovation and support for high-end medical device development [1][2][5] Regulatory Developments - The National Medical Products Administration (NMPA) has implemented special reviews for innovative medical devices that are domestically created, internationally leading, and clinically valuable, aiming to optimize the review process [1][2] - The NMPA plans to enhance the legal and standard framework, increase support for research and development, and improve the efficiency of reviews and approvals [1][2] Industry Trends - The number of approved innovative medical devices has been increasing annually, with a 87.5% year-on-year growth in the first half of 2025 [2] - The domestic medical imaging industry has seen improvements in the supply chain and production capabilities, with many mid-to-low-end products achieving domestic substitution [2][3] Challenges in Domestic Production - Despite advancements, there are still significant challenges in foundational research, software development, and reliance on imported key components [3][4] - The overall market share of domestic high-end medical imaging equipment remains low, indicating ongoing dependency on foreign technology [3][4] Strategic Initiatives - The NMPA has established innovation cooperation platforms for artificial intelligence and biomaterials to facilitate the transformation of research into practical applications [5] - The Ministry of Industry and Information Technology and the NMPA have announced initiatives to focus on key materials and technologies to enhance domestic production capabilities [5] Expert Consultation Mechanism - The NMPA has introduced an expert consultation mechanism to guide innovative medical device companies through the development and approval process, ensuring comprehensive understanding of cutting-edge technologies [7][8] - The expert consultation process includes a diverse pool of approximately 2,500 experts across various medical and technical fields to support the review and evaluation of innovative products [8][9] Focus Areas for Future Development - Future research in artificial intelligence medical devices is expected to concentrate on wireless diagnostics, digital therapies, brain-machine interfaces, and flexible wearable devices [6]