Core Viewpoint - The article discusses the challenges faced by major medical device companies, specifically Philips, GE Healthcare, and Siemens Healthineers (collectively referred to as GPS), in the Chinese market and globally due to trade wars and increasing competition. The companies are focusing on localization and adapting their strategies to navigate these challenges effectively [1][3][5]. Group 1: Market Challenges - In 2024, Philips experienced a double-digit revenue decline in the Chinese market, a trend mirrored by GE Healthcare and Siemens Healthineers [1][5]. - The trade war has significantly impacted GPS, with GE Healthcare estimating a loss of approximately $380 million due to tariffs by 2025, while Philips anticipates losses between €250 million to €300 million [4][5]. - The overall market environment is characterized by intensified competition, price pressures, and the need for strategic adaptation in response to new tariffs [5][14]. Group 2: Localization Efforts - Philips has achieved over 95% of its products being manufactured locally in China, positioning the country as a key supply chain and manufacturing hub [7][8]. - GE Healthcare emphasizes the importance of localizing every component, not just the equipment, to enhance supply chain resilience and quality [9][10]. - Both companies recognize the necessity of building local ecosystems and training talent to support their localization strategies [10][11]. Group 3: Competitive Landscape - Local Chinese companies like United Imaging, Neusoft, and Mindray are emerging as strong competitors, moving beyond imitation to innovation and price competition [14]. - The growing demand for healthcare solutions in China, driven by an aging population and increasing chronic diseases, presents ongoing market opportunities for GPS [14][15]. - The companies are adapting their strategies to focus on specific market segments rather than attempting to cover all areas, indicating a more targeted approach to competition [15].

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].

Group 1 - The European Commission has imposed a ban on Chinese medical device companies from participating in public tenders exceeding €5 million (approximately ¥40 million), which is expected to reshape the global medical device industry landscape [2][3] - The ban is part of a broader trade conflict centered around "fair competition," with the EU's investigation into China's procurement practices highlighting the requirement for a certain level of domestic production [3][4] - China's Ministry of Finance responded with a countermeasure, excluding EU companies from government procurement projects valued over ¥4.5 million, specifically targeting 50 types of medical devices imported from the EU [5][6] Group 2 - Despite the challenges posed by the EU's procurement barriers, the Chinese medical device industry still sees potential in overseas markets, particularly in regions with unmet medical needs such as Asia, Africa, and Latin America [6][7] - Companies are encouraged to adapt their strategies by collaborating with local firms and establishing overseas production bases to navigate trade barriers and maintain market presence [6][7] - The global medical device supply chain is undergoing rapid restructuring, indicating a shift in competitive dynamics as new markets emerge [7]

资本盛宴背后，实控人刘海峰团队也面临考验：若此次港交所闯关失败，可能触发与投资机构签订的回 购协议。在市场份额触顶、盈利未现、替代威胁加剧的背景下，留给大医集团的时间不多了。 王者面临产品小众烦恼 时隔4年，国内伽玛放射外科设备龙头企业西安大医集团股份有限公司（以下简称大医集团），再次向 资本市场发起冲刺，此次目标转向港交所。 根据最新招股书，大医集团在中国伽玛刀（精准聚焦伽玛射线的放射治疗设备）市场占据绝对主导地 位，2024年市场份额高达70%。需注意的是，领先的市场份额却未给公司业绩带来起色。大医集团2023 年和2024年营收不及4年前，净亏损还较4年前扩大了数倍。 细分领域王者却赚不到钱？这一巨大反差也令市场疑虑公司核心产品的未来成长性。业内分析指出，作 为癌症治疗手段之一的放疗设备，伽玛刀虽然精准度高，但受技术原理限制，治疗部位主要集中于头 部。相比之下，直线加速器等放射治疗设备可以实现全身多部位治疗，正在医疗机构采购中占据更大比 重。 《每日经济新闻》记者注意到，此前资本对大医集团颇为看好。高瓴资本、方略资本、招商局创投领衔 十余家明星机构，长春市财政局、西安市财政局等国资平台均参与投资。大医集 ...

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 ...

Core Insights - Philips is facing significant challenges in the Chinese market, with a double-digit revenue decline reported in 2024, coinciding with the appointment of a new president for the Greater China region [1][4] - The global medical device market, particularly for major players like GE Healthcare, Siemens Healthineers, and Philips (collectively referred to as GPS), is under pressure due to trade wars and tariffs, impacting their financial performance [3][6] - The need for localization and supply chain resilience is emphasized, with Philips aiming for over 95% of its products to be manufactured locally in China, despite some core components still being imported [8][9] Market Performance - In 2024, GE Healthcare's revenue in China declined by 15%, while Siemens Healthineers reported a 14% drop in the same period, indicating a broader trend of revenue challenges among GPS companies in the region [5][12] - Philips anticipates continued revenue decline in the Chinese market into 2025, projecting a mid-single-digit percentage drop [4][12] Strategic Responses - Philips is focusing on increasing localization and integrating into the Chinese ecosystem, with plans to enhance local production capabilities and reduce reliance on imports [8][10] - The company has appointed a new Chief Competitiveness Officer to drive innovation and improve product competitiveness in response to local market dynamics [12][14] Competitive Landscape - Local Chinese medical device companies are emerging as strong competitors, with firms like United Imaging, Neusoft Medical, and Mindray gaining traction and challenging established players [12][14] - The competitive environment is expected to intensify, with price pressures and increased competition being common challenges faced by all GPS companies [6][12] Future Outlook - The Chinese market is viewed as a significant growth opportunity due to its large population and increasing healthcare demands, particularly in chronic disease management [12][13] - Despite current challenges, the long-term outlook for the medical device industry in China remains positive, with companies encouraged to adapt and innovate to meet evolving market needs [13][14]

财政部：对于4500万元人民币以上的医疗器械政府采购项目 在华欧资企业可以参与 金十数据7月10日讯，财政部发布《关于在政府采购活动中对自欧盟进口的医疗器械采取相关措施的通 知》政策问答，其中提到，对于4500万元人民币以上的医疗器械政府采购项目，未分包开展采购的，非 欧盟企业提供的自欧盟进口的医疗器械占比不得超过该项目合同总金额的50%；分包开展采购的，非欧 盟企业提供的自欧盟进口的医疗器械占比不得超过分包后单个采购包合同金额的50%。对于4500万元人 民币以上的医疗器械政府采购项目，在华欧资企业可以参与。但如果其提供的产品中包含自欧盟进口的 医疗器械，则自欧盟进口的医疗器械金额占比不得超过项目合同总金额的50%。 全部或者部分由欧盟 投资者投资，依照中国法律在中国境内经登记注册设立的企业为在华欧资企业，其在中国境内生产的医 疗器械不属于措施限制的范围。 ...

相关链接 财政部：对于4500万元人民币以上的医疗器械政府采购项目 应当排除欧盟企业参与 金十数据7月10日讯，财政部发布《关于在政府采购活动中对自欧盟进口的医疗器械采取相关措施的通 知》政策问答，其中提到对于4500万元人民币以上的医疗器械政府采购项目，应当排除欧盟企业参与， 无论其提供的产品原产自哪里；非欧盟企业参与的，如果其提供的产品中包含自欧盟进口的医疗器械， 则自欧盟进口的医疗器械金额占比不得超过项目合同总金额的50%。是否属于自欧盟进口的医疗器械， 根据产品进口报关单上的原产国确定。 ...

财政部：国有企业采购不属于政府采购范围，《关于在政府采购活动中对自欧盟进口的医疗器械采取相 关措施的通知》不适用于国有企业采购。 ...

中国财政部：对自欧盟进口医疗器械的限制措施不适用于国有企业。 ...