Core Viewpoint - The National Medical Products Administration (NMPA) is accelerating the establishment of quality management system inspection points for high-end medical products, including surgical robots and recombinant collagen, to support the innovation and development of high-end medical devices [1] Group 1: Regulatory Measures - The NMPA has announced measures to optimize the lifecycle supervision of high-end medical devices, focusing on innovative products [1] - Regulatory discussions will be held for representative innovative medical devices, guiding local supervision in provinces with concentrated innovation [1] - The NMPA aims to analyze innovation points and risk points, and develop targeted regulatory measures [1] Group 2: Quality Management System - The NMPA is expediting the formulation of inspection points for quality management systems for various innovative products, including carbon ion/proton therapy systems and animal-derived artificial heart valves [1] - High-end products such as surgical robots, AI medical devices, and recombinant collagen will also have specific quality management system inspection points established [1] Group 3: Capacity Building - The NMPA plans to strengthen the selection and training of national-level inspectors for high-end medical devices [1] - There will be efforts to validate the quality management systems of provincial inspection agencies and enhance their capabilities [1] - The goal is to improve the quality and efficiency of inspections conducted by provincial agencies [1]

转自：新华财经 产业创新是科技创新成果转移转化的最终落脚点。以科技创新"牛鼻子"推动高质量发展向上突围，要把创新成果落到企业发 展、产业升级上，完成科学研究、实验开发、推广应用"三级跳"，才能真正把科技创新转化为新质生产力。怎么落？关键是融 合高校、科研院所和企业等多方力量，面向市场需求凝练科技问题，瞄准产业痛点确定攻关方向，通过"以需定研"让创新更具 靶向性，形成"企业和产业出题、多方联合答题、市场判题"的闭环。2025年苏州市政府工作报告明确十项主要任务，聚焦"突 出创新引领，加快培育新质生产力"，明确提出坚持"产业出题、科技答题"。 英纳电子所在的苏州纳米城内，以新需求撬动新技术，进而催生新产品、拓展新市场的故事每天都在上演。 深耕洁净环保技术创新和装备制造的苏净集团，多年前开始布局智能微粒检测仪，随着产品不断升级，作为颗粒识别参照物的 高品质微球面临紧缺。一次园区对接会上，苏州纳微科技股份有限公司成功接洽，针对苏净集团需求精准供货。据苏净集团总 工程师孙吉勇介绍，纳微科技的微球直径、密度、光学特性等变化系数小，大大提升了参照物的稳定性和一致性。同在园区的 沛嘉医疗科技（苏州）有限公司主营人工心脏瓣膜等 ...

思宇年度活动回顾： 首届全球眼科大会 | 首届全球骨科大会 | 首届全球心血管大会 即将召开： 2025年6月12日，首届全球医美科技大会 2025年7月17日，第二届全球医疗科技大会 2025年9月4-5日，第三届全球手术机器人大会 2025年4月25日，市场监管总局（国家标准委）发布国家标准 《心血管植入器械 人工心脏瓣膜 第3部分：经导管植入式人工心脏瓣膜》（GB/T 12279.3—2025） ， 该标准将于2026年5月1日正式实施。 这是我国 首个针对经导管植入式人工心脏瓣膜（TAVR）产品的国家级标准， 填补了高风险结构性心脏介入器械在国家标准层面的空白。标准由全国医用植入器械 标准化技术委员会归口，修改采用ISO 5840-3，体现了"国际接轨+本土适配"的技术路线。 与此同时，经导管介入整体市场呈现出快速增长态势。据 弗若斯特沙利文 数据显示，2023年中国心血管介入器械市场规模已达501亿元，预计2025年将达到570亿 元。受益于老龄化进程加快、心血管疾病发病率持续上升，以及微创手术技术的广泛普及，市场需求仍在不断释放。 政策层面 ，国家正在持续推进高值耗材集采改革，鼓励创新器械的临床转 ...

Core Viewpoint - The article highlights the growing significance of heart valve diseases in the context of an aging population, with Beijing Bairen Medical Technology Co., Ltd. emerging as a key player in the domestic market for artificial heart valves, breaking the monopoly of foreign companies and achieving self-sufficiency in core technologies [2][3]. Company Overview - Bairen Medical is the only A-share listed company in the structural heart disease sector in China, focusing on original research and innovation for over 20 years [2]. - The company has developed a bioprosthetic valve using bovine pericardium, which surpasses imported products in anti-calcification performance and durability, addressing the long-standing reliance on imported valves for Chinese patients [2][3]. Innovation and R&D - The development of bioprosthetic valves requires advanced animal tissue engineering and chemical modification techniques, with Bairen Medical investing significantly in R&D, with a budget of 151 million yuan in 2024, a 53.26% increase year-on-year, representing 30.17% of its revenue [4]. - The company has received approval for 21 Class III medical device products, with 10 filling domestic gaps, and has launched 11 interventional products covering the entire lifecycle of heart valve treatment [4]. Market Performance - In 2024, Bairen Medical achieved a revenue of 502 million yuan, a 35.41% increase, and a net profit of 146 million yuan, a 27.02% increase, with all three business segments showing growth [5]. - The heart valve replacement and repair segment saw a revenue increase of 64.28%, with artificial biological heart valves growing by 75.06% [5]. International Expansion - Bairen Medical is entering international markets, with over ten products registered in Indonesia and plans to expand to Germany, Singapore, and Japan [6]. - The company acquired a U.S. firm, Tianqiong Innovation, to enhance its capabilities in ePTFE materials, addressing the long-standing issue of dependence on imports [6]. Regulatory and Systemic Innovations - The company aims to accelerate the market entry of high-end medical devices through regulatory innovations, advocating for transparent review standards and improved communication mechanisms in the registration process [6].

合作伙伴征集：2025全球手术机器人大会 报名：首届全球眼科大会 | 暂定议程 报名：首届全球心血管大会 | 奖项报名倒计时 报名：首届全球骨科大会 | 奖项报名倒计时 在医疗科技深度融合临床实践的当下，医学装备行业正经历技术与应用的双重跃迁。从精准诊断到微创治疗，从智能康复到个性化医疗，医学装备的每一次 技术突破都直接影响着医疗质量与患者预后。然而，行业的高速发展不仅带来了创新机遇，也伴随着标准化、适应性落地和成本控制等多重挑战。 在这一背景下， 2025中国医学装备大会暨医学装备展览会 成为观察行业动向的重要窗口。2025年3月13日至16日，重庆国际博览中心将汇聚 800多家企 业 ，展示超过 1000件创新产品 。这不仅是一场技术竞演，更是对医疗装备未来走向的深度探讨——哪些技术能够真正提升临床价值？国产创新如何突破市 场壁垒？政策与产业如何协同推动高质量发展？答案，或将在这次行业盛会上逐步揭晓。 # 会议信息 此次参会的龙头企业包括 强生、雅培、美敦力、直观复星、上海微创机器人、迈瑞医疗、东软医疗、GE医疗、西门子医疗、飞利浦、罗氏、碧迪医疗 等。 34大 专业展区，覆盖了从基础到前沿的每一个细分领 ...