Core Insights - The forum on "Medical Device Technology Review and High-Quality Development" highlighted the rapid growth and innovation in Beijing's medical device industry, with a projected revenue exceeding 1 trillion yuan in 2024 [1][3] - Beijing has established itself as a national innovation hub for the pharmaceutical industry, with over 81 approved Class III innovative medical devices, accounting for more than 20% of the national total [1][3] - The city is leading in the number of artificial intelligence medical products and surgical robots, further solidifying its position in the medical device sector [1][3] Industry Development - The medical device industry is increasingly recognized for its importance in the health sector, with Beijing forming significant advantages through policy support and industry collaboration [3] - As of 2024, the medical device industrial output value is expected to reach 48 billion yuan, with retail and wholesale values at 390 billion yuan [3] - The Beijing Drug Administration has implemented measures to streamline the review and approval process, reducing the average review time for Class II medical devices to 43 working days [3] Innovation and Regulation - The Beijing Economic and Technological Development Area (Yizhuang) is a key area for the development of the medical and health industry, housing over 5,000 enterprises and accounting for nearly half of the city's output [4] - Yizhuang has entered 56 products into the national special review process for innovative medical devices, with 25 approved for market launch [4] - The area aims to create a world-class medical device industry cluster through a dual-driven approach of foreign investment and local ecosystem development [5] Expert Support and Collaboration - The National Medical Products Administration's Medical Device Technical Review Center has over 2,500 experts, including 41 academicians, providing technical support for the review process [6] - A collaborative platform for innovative biomaterials was established to address critical issues in the field, emphasizing the strategic importance of mastering core technologies [7] Clinical Applications - The forum discussed the regulatory focus on specific medical devices, such as orthokeratology lenses, with domestic products accounting for two-thirds of the market [8] - Artificial intelligence medical devices are generating numerous clinical application scenarios, enhancing medical supply capabilities and optimizing treatment processes [9]

据王厚廷介绍，截至目前，北京市取得的三类创新医疗器械81个，占全国的五分之一以上，人工智能产 品58个、手术机器人34个，数量均居全国首位，生产企业1138家，其中，三类388家、二类518家。2024 年，北京健康产业营收突破了1万亿元，医疗器械工业产值480亿元，市场经营和贸易的医疗器械1863亿 元，批零3900亿元。 为打通医疗器械创新转化的"高速路"，北京市药监局以"监管护航、服务提速"为导向，打出"组合拳"。 在审评审批上，修订发布《北京市医疗器械快速审评审批办法》，推行全程网办，第二类医疗器械首次 注册技术审评平均用时缩短至43个工作日，跑出了"北京速度"。在技术支撑上，综合性医疗器械检验基 地二期项目已经全面投入使用，获批北京市"创新医疗器械检验与安全性评价"北京市重点试验室，获授 权检验能力1661项。在成果转化上，深化"三医"联动，实施"项目制"清单管理，目前已纳入清单产品超 120个。 亦庄作为北京医药健康产业发展核心承载区之一，产值规模占全市近一半，集聚5000余家各类医药健康 企业，经过多年培育基本形成了特色鲜明、优势突出的发展格局。北京经济技术开发区管委会副主任刘 力介绍，截至20 ...