（来源：中国医药报） 转自：中国医药报 □ 王嘉薇 方深科 赵阳 自国家药监局部署实施"春雨行动"以来，浙江省药监局通过深化前置服务、强化研审联动、拓展部门协 作，努力打通医疗器械从"实验室"到"生产线"的转化路径，助推"浙造器械"在政策"春雨"滋润下焕发蓬 勃生机，结出丰硕成果。 强化顶层设计 构建协同推进"一盘棋" 浙江省药监局坚持制度先行、联动发力，为"春雨行动"落地提供坚实的组织保障和机制支撑。"春雨行 动"启动后，浙江省药监局党组高度重视，第一时间召开专题部署会，组建"春雨行动"工作专班，制定 细化实施方案，建立定期会商、信息通报、督导落实等工作机制，确保责任到人、任务到岗、措施到 位，形成高效运转的内部推进体系。与此同时，积极争取并成功为浙江省医疗器械审评中心新增事业编 制19名，显著增强了省级审评核心力量。 临床成果转化涉及多环节、多部门，浙江省药监局主动加强部门协同，凝聚创新合力。浙江省药监局与 省卫生健康委迅速达成共识，联合推进"春雨行动"。浙江省医疗器械审评中心与省医学教育科技发展中 心（省卫生健康委直属单位）联合发文，面向全省各级医疗机构广泛征集临床研究成果转化项目，扩大 政策知晓度和覆 ...

播洒政策"及时雨" "以前，医疗机构、科研院所的很多科研项目止步于获得发明专利、刊发学术文章，转化为医疗器械的 意识不足。近年来，随着各相关机构推进纵向课题研究，鼓励研究成果转化，'不会转'的问题变得更加 突出。"四川省药监局医疗器械注册管理处工作人员蔡云龙介绍，临床医生和技术专家在医疗器械开发 上面临知识体系差异、研发协作、法规理解等多方面困难。 这并非一时一地的挑战。临床需求是医疗器械创新的源头活水，如何让一线的创新灵感转化出医疗器 械？借助"春雨行动"，各试点省份着力破题解难。 "春雨行动"启动以来，试点省份药品监管部门主动向前一步，深入医疗机构，传递政策导向，深入探讨 医工转化面临的现实瓶颈，研究解决策略，并向临床医生抛出"橄榄枝"。 2025年6月，在北京举办的医疗器械临床研究成果转化推进会覆盖了132家三级医院、10家科研院所及50 家领军企业。会议不仅介绍相关政策，还由医疗机构代表与企业代表分享医工协同创新的实践路径，展 示从临床痛点挖掘、跨学科团队组建到技术难题攻克的全流程转化经验。 （来源：中国医药报） 转自：中国医药报 医疗器械临床研究成果转化"春雨行动"持续推进，多地药品监管部门在新一年 ...

要让医疗器械创新发展真正驶入快车道，各级药品监管部门须以"春雨行动"为契机，正确把握安全监 管、产业发展与为民服务的关系，做到"保安全"与"促发展"有机统一。 （来源：中国医药报） 转自：中国医药报 □ 本报特约评论员 创新是引领发展的第一动力，是医疗器械产业高质量发展的生命力。2025年4月，国家药监局启动"春雨 行动"，聚焦打通临床创意到产品上市的全链条堵点，推动医疗器械源头创新高效转化。短短数月内， 11个试点地区积极探索，涌现出一批新做法和新成效，推动我国医疗器械创新生态体系建设迈入新阶 段，也彰显了药品监管部门统筹发展与安全、服务新质生产力的战略远见。 好雨知时节，当春乃发生。正如春雨催生春意，催发生机和活力。"春雨行动"并非简单征集临床研究成 果项目，而是构建覆盖"需求挖掘—平台对接—审评提速—政策协同"的全链条服务体系，着力破解长期 存在的"临床需求找不到企业承接、企业研发找不到临床痛点"难题。其核心是以临床价值为导向，"从 患者中来、到患者中去"，真正践行"监管为民"理念，为医疗器械创新发展提供不竭动力。 各地因地制宜的探索，印证了"春雨行动"的可操作性：广东省药监局以"四个一"落实"春雨行动 ...

Core Viewpoint - The meeting on December 3, organized by the National Medical Products Administration, aims to advance the transformation of clinical research results in medical devices through the "Spring Rain Action" initiative, with a focus on nationwide implementation and accelerating product market entry [1] Group 1: Key Actions and Requirements - Participating pilot provinces are required to accurately grasp the key aspects of the "Spring Rain Action" [1] - There is an emphasis on strengthening policy promotion and training, as well as conducting project collection and evaluation [1] - The initiative encourages active development of categorized guidance services and project matching [1] Group 2: Collaborative Efforts and Innovation - The meeting highlights the need to improve cross-departmental collaboration mechanisms and enhance registration service capabilities [1] - It promotes innovation in medical devices driven by clinical value [1] - The goal is to transition the "Spring Rain Action" from pilot provinces to a nationwide regular operation [1]

Core Viewpoint - The meeting on December 3 emphasized the importance of advancing the clinical research results of medical devices through the "Spring Rain Action," aiming for nationwide implementation and faster product market entry [1] Group 1: Key Actions and Requirements - Participating pilot provinces are required to accurately grasp the key aspects of the "Spring Rain Action" [1] - There is a need to strengthen policy promotion and training, ensuring effective project collection and evaluation [1] - The meeting called for active development of categorized guidance services and improved project matching and coordination among departments [1] Group 2: Innovation and Market Entry - The initiative aims to enhance the capacity for registration services and promote innovation in medical devices driven by clinical value [1] - The goal is to transition the "Spring Rain Action" from pilot provinces to a regular nationwide operation, accelerating the product launch process [1]

Core Viewpoint - The "Spring Rain Action" initiative aims to promote the transformation of clinical research results in medical devices, enhancing innovation and industrialization processes in Guangdong's medical device sector [3][4]. Group 1: Policy and Implementation - The "Spring Rain Action" is a significant measure led by the National Medical Products Administration (NMPA) to facilitate the transformation of innovative medical device research results [3]. - Guangdong has established a comprehensive implementation plan for the "Spring Rain Action," which includes setting clear objectives, standards, and mechanisms for clinical research result collection and evaluation [4][5]. - The province's drug regulatory authority has emphasized the importance of early intervention and tailored support for medical device projects to streamline the approval process [5]. Group 2: Industry Status and Achievements - As of June 2025, Guangdong has 8,983 medical device production enterprises and over 1.76 million registered products, leading the nation in both categories [2]. - The province has received approval for 25 innovative drugs and 48 innovative medical devices, showcasing significant breakthroughs in the industry [2]. - Guangdong is home to 250 tertiary hospitals and 50 high-level hospitals, providing a robust platform for clinical trials and research [2]. Group 3: Collaborative Efforts and Future Directions - The training session for the "Spring Rain Action" involved over 60 representatives from various medical and research institutions, fostering collaboration across the medical, academic, and regulatory sectors [6]. - The initiative aims to create a coordinated mechanism involving multiple stakeholders to enhance the transformation of clinical research results into practical applications [6]. - The provincial drug regulatory authority plans to leverage this training as a catalyst for further collaboration and innovation in the medical device field [6].

Core Insights - Guangdong Province has the highest number of pharmaceutical and medical device manufacturers in China, with a total of 8,983 companies and over 1.76 million registered products as of mid-2023 [1] - The "Spring Rain Action" initiative aims to enhance the transformation of clinical research results in medical devices, promoting innovation and industrialization in the sector [2] Group 1: Industry Overview - Guangdong leads the nation in the number of pharmaceutical, medical device, and cosmetic production companies, as well as in the stock of registered products and the number of approved innovative products [1] - The province has received approvals for 25 Class I innovative drugs and 48 innovative medical devices from the National Medical Products Administration in recent years [1] - Guangdong is home to 250 tertiary hospitals and 50 high-level hospitals, providing a strong clinical trial research platform [1] Group 2: Spring Rain Action Initiative - The "Spring Rain Action" is a key initiative led by the National Medical Products Administration to promote the transformation of innovative medical device research results [2] - The initiative focuses on collecting clinical doctors' innovative ideas and effectively connecting them with medical device research and development needs [2] - Guangdong has developed an implementation plan for the "Spring Rain Action," emphasizing the importance of this initiative for the high-quality development of the biopharmaceutical industry in the province [2]