创新破局 国产高端医疗器械崛起正当时

Core Insights - The article highlights the rise of domestic high-end medical devices in China, with a significant increase in innovation and production, supported by favorable policies and regulatory reforms [1][2][3] Industry Transformation - The high-end medical device industry in China is transitioning from reliance on imports to domestic production, with a focus on innovation and quality improvement [2][4] - The number of approved innovative medical devices reached 76 in 2025, maintaining a high level for three consecutive years, covering various advanced fields [1][2] Regulatory Support - The National Medical Products Administration (NMPA) has implemented reforms to streamline the approval process for innovative medical devices, enhancing efficiency and encouraging innovation [3][6] - Key measures include special reviews, priority approvals, and a focus on early-stage guidance for companies, which have significantly shortened the time from development to market [3][6] Breakthrough Innovations - Several notable products were approved in 2025, including a transcatheter aortic valve system and advanced imaging technologies, showcasing the capabilities of domestic companies to break import monopolies and achieve competitive technical standards [5][6] Market Integration - The improvement of the medical insurance system and procurement mechanisms has made high-end medical devices more accessible to grassroots hospitals, reducing costs and enhancing availability [6][7] - Since the 14th Five-Year Plan, 292 innovative medical devices have been approved, representing a 3.3-fold increase compared to the previous five-year period [6][7] Global Expansion - Chinese medical device exports accounted for approximately 8% of the global market in 2024, positioning China as the fourth-largest exporter [7] - Chinese companies are increasingly participating in international regulatory discussions and establishing overseas R&D centers, facilitating global market integration [7]