央视网消息：国家药监局日前发布10条举措，大力支持我国高端医疗器械创新发展。最新出台的政策主要聚焦哪些高端医疗器械？有哪些是国 内首创或是国际领先的措施？我国高端医疗器械企业、患者和产业将迎来哪些利好？ 国家药监局医疗器械注册司司长吕玲介绍，这次支持举措重点选取了医用机器人、高端医学影像设备、新型生物材料医疗器械、人工智能医疗 器械。因为它们是高端医疗器械的典型代表性产品，也是塑造医疗器械新质生产力的关键领域，也充分代表着当前医疗器械行业发展的方向。 国家药监局表示，当前，出台这些重磅措施支持高端医疗器械发展，希望促进更多新技术、新材料、新工艺和新方法应用于医疗健康领域。 吕玲表示，比如基于脑机接口技术的医疗器械、腹腔内窥镜手术系统、多病种大模型的人工智能医疗器械等，这些都是他们目前聚焦的重点产 品。通过以点带面，通过大力支持这些代表性产品，努力抢占国际制高点，使得更多"中国造、全球新"的医疗器械早日上市。 相关数据统计，2023年，我国高端医疗器械市场规模已突破8000亿元，近10年的复合增长率基本保持在10%以上，近5年复合增长率达18%。 随着政策落地，我国在智能诊疗、精准医疗等领域有望实现跨越式发展。 ...

国家药监局日前发布十条举措，大力支持我国高端医疗器械创新发展。那么，最新出台的新政策，主要 聚焦哪些高端医疗器械？有哪些是国内首创或是国际领先的措施？我国高端医疗器械企业、患者和产业 将迎来哪些利好？本台记者独家采访国家药监局相关业务的负责人进行解读。 我国出台新政助推高端医疗器械万亿市场 国家药监局医疗器械注册司司长吕玲：这次的支持举措我们重点选取了医用机器人、高端医学影像设 备、新型生物材料医疗器械、人工智能医疗器械，因为它们就是高端医疗器械的典型代表性产品，也是 塑造医疗器械新质生产力的关键领域，也充分代表着当前医疗器械行业发展的方向。 国家药监局表示，当前出台这些重磅措施支持高端医疗器械发展，希望促进更多新技术、新材料、新工 艺和新方法应用于医疗健康领域。 国家药监局医疗器械注册司司长吕玲：比如基于脑机接口技术的医疗器械，还有腹腔内窥镜手术系统， 还有多病种大模型的人工智能医疗器械等等，这些都是我们目前聚焦的重点产品，我们就是要通过以点 带面，通过大力支持这些代表性的产品来努力抢占国际制高点，使得更多"中国造、全球新"的医疗器械 早日上市。 国家药监局医疗器械注册司司长吕玲：比如产品上市前我们将审评的 ...

上天天基金APP搜索【777】注册即可 领500元券包，优选创新药基金10元起投！限量发 放！先到先得！ 重磅利好。 据新华社消息，中共中央政治局委员、国务院副总理刘国中10日到北京大学医学部调研医药创新发展工 作。他强调，要深入学习贯彻习近平总书记关于科技创新和卫生健康工作的重要指示精神，按照党中央、 国务院部署，面向人民生命健康，强化协同攻关和政策落实， 加强医药领域基础研究和科技创新能力建 设，积极支持创新药和医疗器械加快发展 ，为推进健康中国建设提供有力支撑。 刘国中来到北京大学医学部药学院，详细了解有关药物研发、重点实验室建设运行等情况，并主持召开座 谈会，听取相关企业、高校、科研院所、医疗机构的意见建议。他强调，医药是人类与疾病斗争的有力武 器。近年来，我国医药创新发展呈现良好态势，医药研发能力、市场竞争力和创新活力显著提升。 要坚定 信心，充分发挥我国在产业体系、发展环境等方面优势，聚焦重点难点问题，有力推动医药创新和产业高 质量发展。要加强产学研深度融合，鼓励企业、高校、科研机构与医疗机构联合攻关，提高医药科技创新 水平，在药物、疫苗和医疗器械研发方面取得更多突破性成果。 要加强人才培养和综合 ...

Core Viewpoint - The Chinese government emphasizes the importance of strengthening pharmaceutical innovation and development to support public health and enhance the country's healthcare system [1][2]. Group 1: Pharmaceutical Innovation - The Vice Premier Liu Guozhong highlighted the need for collaboration in tackling key challenges in the pharmaceutical sector, aiming to boost innovation and high-quality development [2]. - Recent years have seen significant improvements in China's pharmaceutical research capabilities, market competitiveness, and innovation vitality [2]. - The government encourages deep integration of industry, academia, and research institutions to enhance pharmaceutical technology innovation, particularly in drug, vaccine, and medical device development [2]. Group 2: Regulatory Support - The National Medical Products Administration (NMPA) is working on optimizing the clinical trial review and approval process for innovative drugs, aiming to complete reviews within 30 working days for eligible applications [3]. - The NMPA has also approved measures to support the innovation of high-end medical devices, emphasizing the importance of a comprehensive regulatory reform in the medical device sector [4]. - Specific measures include optimizing special approval processes, improving classification and naming principles, and enhancing post-market surveillance and quality monitoring [4]. Group 3: Future Initiatives - The NMPA plans to release detailed guidelines soon, focusing on coordination and clarifying requirements to ensure the successful implementation of new initiatives [5].

6月20日，国家药监局党组书记、局长李利主持召开会议，研究部署支持高端医疗器械创新发展举措，审 议通过《关于优化全生命周期监管支持高端医疗器械创新发展的举措》（以下简称《举措》）。 会议指出，党中央、国务院高度重视高端医疗器械创新发展，党的二十届三中全会明确提出要健全支持创 新医疗器械发展机制，2024年，国务院办公厅印发《关于全面深化药品医疗器械监管改革促进医药产业高 质量发展的意见》（国办发〔2024〕53号）， 提出要深化药品医疗器械监管全过程改革，明确了医疗器 械领域支持要点 。医用机器人、高端医学影像设备、人工智能医疗器械和新型生物材料医疗器械等技术集 成度高，是高端医疗器械的典型产品，也是塑造医疗器械新质生产力的关键。《举措》包括优化特殊审批 程序、完善分类和命名原则、持续健全标准体系、进一步明晰注册审查要求、健全沟通指导机制和专家咨 询机制、细化上市后监管要求、强化上市后质量安全监测、密切跟进产业发展、推进监管科学研究和推动 全球监管协调等十方面具体措施。 《举措》的出台对支持高端医疗器械重大创新，促进更多新技术、新材 料、新工艺和新方法应用于医疗健康领域，满足人民群众健康需求具有重要意义，是药 ...

朱融融：这款生物材料，能够通过促进神经再生，诱导轴突方向性生长重塑神经环路等作用效果，加速 脊髓损伤修复进程，其实是打造了一个神经中继站。讲得通俗一点，如果脊髓断掉，神经网络就不存在 了，大脑发出的电信号也就传不过去。因此，我们研发出了一种新的生物材料，让中间断开的神经连接 起来，并促进神经元重新继续生长，形成一个新的神经网络，脑部的信号就能通过这个中间桥，传递给 下游的肌肉和感觉效应器转化为运动信号，下游的肌肉和感觉效应器的电信号也能够回传给脑部。由 此，这个人造的"支架"就具备了原生神经器官的功能。 心智观察所：最初是什么样的契机，让您决定投身于这样一个很有意义的领域呢？ 朱融融：一个很偶然的机会，我参加了2016年程黎明老师的重点研发计划。该计划主要任务就是攻克脊 髓损伤修复难题。我其实最早是做生物材料的，在2016年之前我基本都只是做生物材料的各种设计，更 多的是用于抗肿瘤方面，涉及再生的并不多。 【对话/观察者网心智观察所】 脊髓损伤，这一曾令医学界束手无策的难题，正因一位科学家的突破性研究迎来曙光。同济大学教授朱 融融博士，带领团队研发出全球首个可注射神经系统生物材料修复支架。这一技术为全球数百万 ...

Core Viewpoint - The recent announcement of measures to support the high-quality development of innovative drugs has also positively impacted the high-end medical device sector, with the National Medical Products Administration (NMPA) introducing specific policies to enhance innovation in this field [1][3]. Group 1: Policy Measures - The NMPA's announcement includes ten specific measures aimed at optimizing special approval processes and improving classification and naming principles for high-end medical devices [1]. - The measures emphasize a full lifecycle regulatory approach to support significant innovations in high-end medical devices, facilitating the transformation of new technologies, materials, and methods into marketable products [1][3]. - The measures are expected to enhance the efficiency of material submissions, approvals, and research and development for companies in the medical device industry [1][4]. Group 2: Market Impact - Following the announcement, several medical device companies saw significant stock price increases, with companies like Hotgen Biotech rising by 20% and others like Zhongyuan Union and Jianfan Bio increasing by nearly 10% [2]. - The measures are anticipated to accelerate the market entry of high-end medical devices, particularly those related to artificial intelligence and new biological materials [3]. Group 3: Regulatory Improvements - The measures propose to streamline the approval process for high-end medical devices, reducing the average approval cycle from 12 months to potentially 9 or 10 months [3][4]. - The NMPA aims to enhance the standardization of medical devices, including the development of standards for medical robots and artificial intelligence devices [4][6]. - The focus will also be on improving post-market surveillance and quality safety monitoring for innovative products [6]. Group 4: Internationalization and Challenges - The measures support high-end medical device companies in participating in international standard-setting and expanding their global market presence [7]. - Despite advancements, challenges remain for Chinese companies in terms of technology implementation and market competition with established Western firms, which may require significant time and investment [8].

Core Viewpoint - The National Medical Products Administration (NMPA) of China is implementing special reviews for high-end medical devices that are domestically innovative, internationally leading, and have significant clinical application value to support their development and international expansion [1][2][3] Regulatory Measures - The NMPA has announced ten key measures focusing on the entire lifecycle regulation of high-end medical devices, including optimizing review and approval processes, strengthening post-market supervision, and enhancing standard system construction [1][2] - The approval time for clinical trials of medical devices has been reduced from 60 working days to 30 working days, with a focus on advancing the review process to the product development stage [2][3] Innovation and Approval Process - Since 2014, the number of approved innovative medical devices has significantly increased from 33 to 323 by April 2023, indicating a rapid acceleration in technology breakthroughs and product launches in high-end medical devices [3] - The NMPA will continue to implement special reviews for high-end innovative medical devices, ensuring priority processing under the principles of early intervention, dedicated responsibility, and scientific review [3][4] Standardization and Guidance - The NMPA aims to enhance standardization research to help domestic high-end medical devices compete internationally, emphasizing the need for improved registration and classification guidance [4][5] - Key areas of focus for standardization include artificial intelligence, brain-computer interfaces, and new biological materials, with plans to establish technical organizations for standardization in these fields [5][6] Post-Market Supervision - The NMPA will strengthen post-market supervision requirements for innovative medical devices, encouraging manufacturers to conduct post-market evaluations and real-world studies to enhance product safety and reliability [5][6] - The regulatory framework will also be improved to support companies in expanding their international market presence, including policies related to export sales certification [6]

Group 1 - The medical device sector is experiencing strong performance, with the medical device ETF (159797) rising by 1.08% and attracting net inflows for the second consecutive day [1][3] - The majority of the constituent stocks of the medical device ETF saw gains, with notable increases such as Hotgen Biotech rising over 11%, and Xiangyu Medical and Xinmai Medical both increasing over 8% [3] - The National Healthcare Security Administration and the National Health Commission issued measures to support the high-quality development of innovative drugs, which includes enhancing the use of medical insurance data for drug research and improving the dynamic adjustment mechanism for the basic medical insurance drug list [3] Group 2 - The release of the RuiPath pathology model by Ruijin Hospital marks a significant advancement in domestic medical AI, transitioning from technical breakthroughs to ecosystem sharing [4] - The measures approved by the National Medical Products Administration aim to optimize the lifecycle regulation to support the innovation of high-end medical devices, including improving special approval processes and enhancing communication mechanisms [5] - The external skeleton robot industry is viewed positively due to recent technological breakthroughs and product innovations, with applications in both medical and industrial sectors expected to grow rapidly [6][7] Group 3 - The medical device ETF (159797) encompasses a wide range of medical equipment and diagnostics, with the top ten weighted stocks accounting for nearly 47% of the fund [7][8] - The top holdings in the medical device ETF include Mindray Medical (14.65%), United Imaging Healthcare (9.44%), and Aimeike (3.95%) among others [8]

Group 1 - The core viewpoint is that by 2025, domestic PFA brands are expected to enter a rapid commercialization phase, gradually replacing traditional radiofrequency and cryoablation technologies due to their non-thermal ablation characteristics, shorter operation times, lower complication risks, and better long-term efficacy [1] - Six domestic brands have already been approved, indicating a growing market presence [1] - The National Medical Products Administration has approved measures to optimize the lifecycle regulation to support the innovation and development of high-end medical devices, which includes ten initiatives aimed at promoting the development of medical robots, high-end medical imaging equipment, AI medical devices, and new biological materials [1] Group 2 - The medical device sector is currently valued at historical lows, with policy benefits expected to materialize starting from Q2 2025, particularly in the AI + imaging/surgery direction [1] - The innovative drug sector is experiencing short-term fluctuations but is viewed positively in the long term, driven by accelerated overseas expansion and changes in payment systems [1] - The traditional Chinese medicine sector is seeing reduced impacts from centralized procurement, with improved gross margins for OTC products; the blood products industry is experiencing increased concentration and favorable demand for immunoglobulin [1] Group 3 - The retail pharmacy industry is undergoing accelerated clearing, with AI empowerment enhancing operational efficiency and outpatient coordination creating incremental opportunities [1] - The CXO sector is gradually stabilizing in performance, with a recovery in overseas investment and financing driving industry growth [1] Group 4 - The ChiNext Medical ETF tracks the ChiNext Medical Index, which is compiled by China Securities Index Co., Ltd., selecting listed companies in the medical and health industry from the ChiNext market to reflect the overall performance of the medical and biological sector [2] - This index focuses on high-growth and innovative sub-sectors such as biomedicine, medical devices, and medical services, effectively showcasing the investment value and development potential of the ChiNext medical industry [2]