中国创新医疗器械榜：75款【2025年度盘点】

Core Insights - The article discusses the approval of 75 innovative medical devices in China by December 31, 2025, highlighting a shift towards products that follow verifiable clinical pathways and replicable product systems [2]. Overview - Domestic products: 63 items - Imported products: 12 items - Domestic medical devices account for over 80% of the total, with imported products mainly in high-complexity and high-clinical-barrier segments, reflecting "filling-type innovation" [3]. Technical Field Distribution - The cardiovascular field remains the "main battlefield," driven by high disease prevalence and continuous evolution in intervention methods and operational techniques [5]. - Other fields like ophthalmology, neurology, and oncology, while fewer in number, exhibit high technical barriers and clear clinical pathways, characterized by a "few but refined" approach [7]. Approval Rhythm - The approval of innovative devices shows a clear "rhythm" throughout the year, indicating a shift from "periodic concentration release" to "normalized operation" in the innovation channel [9]. - Peaks in approvals were noted in April and December, with other months maintaining a stable release rhythm [11]. Regional Distribution - Innovative medical devices are highly concentrated in regions with dense industrial and research resources, indicating that regional innovation ecosystems (universities, hospitals, capital, manufacturing capabilities) are crucial for the development of innovative devices [12]. Trend Judgments - Three clear trends for innovative medical devices in 2025: - The innovation threshold is shifting from "technically feasible" to "clinically applicable" [14]. - Single-point innovations are insufficient for long-term value; systemic solutions are becoming mainstream [15]. - The evaluation logic for innovation is increasingly focusing on real-world value, with clinical applicability, stability, and learning curves becoming as important as technological advancement [16].