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创新破局 国产高端医疗器械崛起正当时
Xin Hua Wang· 2026-01-06 11:37
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]
最新!又3款创新器械获批上市!
思宇MedTech· 2025-06-27 09:07
Core Insights - The article highlights the upcoming global medical technology conferences and recent approvals of innovative medical devices in China, emphasizing the growth and innovation in the medical technology sector [1][13]. Group 1: Medical Device Approvals - On June 27, 2025, three innovative medical devices received approval from the National Medical Products Administration of China, including a spinal surgery navigation device, a cardiac pulsed electric field ablation device, and a biodegradable magnesium alloy screw [1][2]. - As of now, a total of 360 innovative medical devices have been approved for market in China [1]. Group 2: Spinal Surgery Navigation Device - The spinal surgery navigation device from China-Europe Zhihui (Shanghai) Robot Co., Ltd. is the first in China to utilize micro robotic arm technology, allowing for precise spatial positioning during adult spinal surgeries [3]. - This device significantly reduces the space occupied in the operating room compared to traditional multi-axis robotic arms, enhancing safety and efficiency [3]. Group 3: Cardiac Pulsed Electric Field Ablation Device - The cardiac pulsed electric field ablation device from Shenzhen Maiwei Medical Technology Co., Ltd. is designed for treating drug-resistant, recurrent, symptomatic, and paroxysmal atrial fibrillation [8]. - It is the first device to use nanosecond pulse width high-voltage electric fields for pulmonary vein isolation, providing real-time monitoring and feedback during the ablation process [8]. Group 4: Biodegradable Magnesium Alloy Screw - The biodegradable magnesium alloy screw from Syntellix AG is made from a magnesium-based alloy and is designed to gradually degrade and be replaced by endogenous new tissue within the body [11][12]. - Compared to traditional titanium or steel implants, this product claims to reduce surgical time, costs, pain, and infection risks by half [12].