在现代医疗体系中，医疗器械扮演着至关重要的角色。近日，成都纽创医疗器械有限公司（以下简称"纽创医疗"）宣布，公司正式获得由国际权 威认证机构Intertek颁发的ISO 13485:2016医疗器械质量管理体系认证证书。该认证确认纽创医疗在神经介入产品、外周介入产品、冠脉介入产品 领域的管理体系符合国际标准。 ▲纽创医疗 纽创医疗成立于2021年，是一家专注于血管介/植入领域的国家高新技术企业及专精特新企业，其自主研发的纽创飞戈™外周乳突球囊扩张导管是全球首款 同类产品。纽创医疗副总经理闫峰介绍，在此次获得认证的基础上，公司将持续深化海外市场布局，推动海外市场业务开展。 成功通过国际认证 全球化征程正式起航 "ISO 13485是国际主流医疗市场的强制准入基础，有了这张国际通行证，标志着纽创医疗全球化征程的正式启航"，闫峰告诉红星新闻记者，这是一个国际 通用的体系认证，不是针对某一个具体产品，而是对整个公司的体系认证。对照相关审核标准，公司此前进行了相应准备，最终成功通过。有了这一认证， 公司就可以为全球医疗机构提供更安全、更可靠的创新医疗器械解决方案。 虽然成立的时间并不长，但纽创医疗已经在所属领域取得一系 ...

"AI医疗器械、医疗机器人、呼吸类医疗器械、植入式医疗器械、智慧病理产品等技术集成度高，属于 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。"毕马威中国医疗健康和生命科学行 业税务主管合伙人肖鑫表示，随着AI技术、机器人技术与医疗领域的深度融合，数字化病理、手术机 器人、呼吸健康、创新医疗（002173）器械、智慧病理等整体解决方案应运而生。目前，AI和机器人 技术在医疗领域的应用范围，已从辅助诊断扩展至治疗规划、远程医疗、病理诊断、睡眠呼吸健康等多 个领域，持续推动医疗行业的数字化与智能化转型。 北京市东城区人民政府副区长邓慧敏表示，东城区医药健康产业资源集聚，涵盖了药品研发、生产、流 通、销售及医疗服务等多个环节领域。未来，东城区将更加积极主动融入北京国际科技创新中心建设， 重点建设环球贸易中心、航星园、东方广场、信达中心、永外数字产业园、东北二环、歌华青龙、金宝 街等八个特色鲜明的产业组团，打造安定门外、东直门外、永定门外三处金角银边地区，孵化产业类聚 的"银巷""硅巷""文巷""杏巷"，充分发挥中关村东城园作为科技创新和人才发展双高地作用，实现创新 生态有动力、创新人才有活力、创新企业有实 ...

Group 1 - The establishment of the Hangzhou Overseas Students Association Financial Investment Working Committee aims to leverage the unique advantages and global perspectives of overseas returnees in technology, industry, and finance, facilitating the key processes of project implementation, growth, and financing [1][3] - The committee is expected to respond to the 2025 new financial policy direction by identifying potential technology innovation projects and playing a crucial role in early, small, long-term, and hard technology investments [3] - The committee plans to enhance collaboration with various sectors, including fund towns and government departments, to create a cooperative development environment and establish a long-term incubation mechanism for overseas returnee technology projects [3] Group 2 - The inaugural event included a salon where experts and scholars from technology enterprises, investment institutions, and the financial industry discussed themes such as the Chinese innovative pharmaceutical industry from an investor's perspective and the commercialization of AI investments [3]

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]

7月3日，阿里巴巴集团发布公告称，计划发行本金总额约120亿港元、2032年到期的零息可交换债券。 据了解，此次债券发行募集资金净额，将用于投入云计算基础设施建设和支持国际电商业务发展。 债券发行后，债券将构成阿里巴巴集团之无担保及非次级债务。债券不会产生定期利息。债券将于2032年7月9日到期，除非根据债券条款于该日期前被提前赎回、 回购或交换。 从资本市场表现来看，2025年初至今，阿里健康股价已上涨40%，令阿里巴巴可以凭借其表现获得低成本融资，投入业务发展。 由于可交换债券不涉及新股发行，阿里健康的总股本不会因此稀释。 预计仍保持阿里健康控股权 根据公告，债券将参考阿里健康在香港联交所上市的普通股。阿里巴巴可选择通过交付阿里健康股份、现金或现金与阿里健康股份的组合方式履行交换义务。 即便全部使用阿里健康股票结算，预计阿里巴巴仍将保持对阿里健康的控股权。 公告显示，阿里健康是阿里巴巴集团的并表子公司，阿里巴巴集团持有其约64%的股份。 阿里巴巴集团预计，在债券发行后及未来交换为阿里健康股份后，阿里健康仍将是阿里巴巴集团的旗舰医疗健康平台和并表子公司，并将继续与阿里健康及阿里巴 巴生态系统成员密切合作，推 ...

Core Viewpoint - The draft of the Medical Security Law has been officially presented, aiming to establish a comprehensive legal framework for medical security in China, addressing the fragmented nature of existing regulations and enhancing the management of medical security funds and services [1][2][3]. Group 1: Legislative Background - The need for a cohesive legal framework in the medical security sector has been recognized, with a legislative goal established in 2019 to create one law and several regulations to address the current fragmented legal landscape [2]. - The Medical Security Law has been included in the legislative work plans of the National People's Congress (NPC) for 2021, 2022, and 2023, indicating a sustained commitment to this initiative [2]. - Local legislative efforts have also been made, with provinces like Zhejiang, Jiangsu, and Shanghai enacting their own medical security regulations in recent years [2]. Group 2: Draft Structure and Content - The draft consists of seven chapters covering the medical security system, fund management, service optimization, supervision, and legal responsibilities, reflecting a consensus between central and local legislative bodies [3][4]. - The current draft has reduced content compared to the 2021 consultation draft, omitting significant reforms in medical security, such as centralized procurement of medical supplies [5]. Group 3: Recommendations for Improvement - Experts suggest that the draft should incorporate established legislative goals and include provisions for important reforms like medical payment methods and long-term care insurance [6][7]. - The draft should also enhance the sections on medical services and management services, separating them into distinct chapters for clarity [6]. - There is a call to include provisions for data sharing and protection of personal information in the context of medical security, emphasizing the importance of data in the healthcare sector [7]. Group 4: Enforcement and Oversight - Recommendations have been made to strengthen the enforcement of medical security laws and the establishment of regulatory bodies to oversee the use of medical security funds [8].

证券代码：301033 证券简称：迈普医学 广州迈普再生医学科技股份有限公司 投资者关系活动记录表 编号：2025005 | 投资者关系活 | ☑特定对象调研 □分析师会议□媒体采访 | | | --- | --- | --- | | 动类别 | □业绩说明会□新闻发布会□路演活动 | | | | ☑现场参观□一对一沟通□其他： | | | 参与单位名称 | | | | | 华创证券 李婵娟；国盛证券 杨芳；中邮证券 陈峻；中信 建投 喻胜锋；广发证券 杨正；国泰基金 邱晓旭；前海鑫 | | | 时间 | | 2025年07月03日 10:30-12:00 | | 地点 | 公司展厅及会议室 | | | 上市公司接待 | 董事、副总经理、财务总监 骆雅红 | | | 人员 | 董事、副总经理、董事会秘书 龙小燕 | | | | 证券事务代表 李晓香 | | | 投资者关系活 | 一、公司基本情况 | | | 动主要内容介 | 公司是一家专注于高性能植入医疗器械的科技创新型 | | | 绍 | 企业，是国内神经外科领域唯一同时拥有人工硬脑（脊） | | | | 东正圆投资 钟晓琳；太平养老 张翼；隆象资本 贺艳 ...

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]

Core Viewpoint - The National Medical Products Administration (NMPA) is implementing measures to optimize the lifecycle regulation and support the innovative development of high-end medical devices [1] Group 1: Regulatory Measures - The NMPA emphasizes the management of the usage period for high-end active medical devices [1] - Medical institutions are urged to conduct regular inspections and maintenance of surgical robots, rehabilitation robots, and high-end medical imaging equipment to ensure clinical quality [1] - The NMPA supports medical device registrants in conducting post-market evidence-based research [1] Group 2: Incident Reporting and Monitoring - The NMPA is detailing the types of adverse events related to high-end medical imaging devices and artificial intelligence medical devices, aiming to improve the quality of adverse event reporting [1] - The NMPA continues to promote the Global Harmonization Working Party (GHWP) to actively monitor new projects, focusing on high-risk cardiovascular implantable medical devices [1] - The NMPA is exploring a basic framework for post-market active monitoring of medical devices and methods for database construction [1] Group 3: Safety and Reliability Enhancement - Registrants are guided to proactively conduct post-market evaluations to enhance the safety and reliability of their products [1] - Local authorities are advised to strengthen the construction of inspection and monitoring teams for high-end medical devices, improving their inspection and monitoring capabilities [1]

Core Viewpoint - The National Medical Products Administration (NMPA) has announced measures to optimize the lifecycle regulation and support the innovative development of high-end medical devices, including the establishment of classification guidelines for medical robots such as surgical and rehabilitation robots [1] Group 1: Regulatory Measures - The NMPA aims to strengthen the classification and naming guidance for relevant products to support the registration and application of high-end medical devices [1] - Guidelines for the classification of medical robots, including surgical and rehabilitation robots, will be developed to form a consensus among experts on the naming of medical robots [1] Group 2: Research and Development - The NMPA will conduct research on the management attributes and categories of new functions, technologies, and modalities of products such as medical large models, AI medical devices, synthetic biological materials, medical imaging preprocessing, and process optimization software [1] - The management categories of products will be dynamically adjusted based on the maturity of technological development [1] Group 3: Component Management - The NMPA will refine the management requirements for core components of medical robots and high-end medical imaging equipment [1]