引言
近日，受国际权威法律评级机构钱伯斯（Chambers & Partners）邀请，中伦律师事务所合伙人邱靖，以及律师陈方强、夏约、张家平为其独家撰写了《钱伯斯医疗健康：医疗器械全球实务指南》（2025年）“中国篇：趋势与发展”部分。
Recently, at the invitation of the preeminent international legal rating agency Chambers & Partners, Zhong Lun partner Jim Qiu, along with associates Cary Xia, Harvey Chen, and David Zhang, exclusively authored the Healthcare: Medical Devices 2025: Trends and Developments.
该文系统性地梳理了2024至2025年间中国医疗器械行业的深刻变革。文章对《医疗器械管理法（征求意见稿）》带来的“全生命周期”监管理念、市场准入与审查体系的优化、本土化与集中带量采购重塑下的市场格局、以及人工智能与数字健康等前沿领域的监管挑战与机遇进行了全面解读。文章旨在帮助跨国及本土企业在快速演进的监管与市场环境中把握航向盈为国际，实现稳健合规发展。
The article provides a systematic overview of the profound transformations within China’s medical device industry throughout 2024 and 2025. It offers a comprehensive analysis of the “full lifecycle” management system introduced by the Medical Device Administrative Law (Draft for Comment), the optimization of market access and review regime, the market reshaping under localization and Volume-Based Procurement (VBP), and the regulatory challenges and opportunities in frontier domains like artificial intelligence (AI) and digital health. The guide aims to help multinational and domestic companies navigate the rapidly evolving regulatory and market landscape to achieve robust and compliant growth.
钱伯斯作为业内备受认可的国际权威法律评级机构之一，每年都邀请各个国家（地区）在相关法律实践领域领先的律师分享他们的实践经验和当地一线的法律监管状况，其年度更新的全球各国法律指南深受业内和客户关注。中伦律师事务所在生命科学与医疗健康领域拥有卓越的专业能力，提供涵盖产品全生命周期的综合性法律服务。中伦融合了精深的行业监管洞察与卓越的交易实践能力，协助客户应对复杂的监管环境，确保创新解决方案顺利进入市场并保持合规。中伦常年并多次在钱伯斯的医疗健康领域获得排名，充分证明了中伦的业绩与行业领导力。
Chambers & Partners, a highly esteemed international legal rating agencies, annually invites leading lawyers from various jurisdictions to share their practical experience and insights into local first-hand legal and regulatory conditions. The resulting annually updated global practice guides are highly regarded by legal professionals and clients. Zhong Lun has an exceptional team in the life sciences and healthcare sector, offering comprehensive legal services across entire product lifecycles. By combining deep industry-specific regulatory insight with profound transactional capabilities, we assist clients in navigating complex regulatory environments盈为国际, enabling them to bring innovative solutions to the market while maintaining compliance. Zhong Lun has been consistently ranked by Chambers in the healthcare sector, a testament to our performance and industry leadership.
作者简介
邱靖 律师
中伦律师事务所 ]article_adlist-->合伙人
邱靖律师服务于众多跨国及本土医疗健康机构，包括生物技术公司、制药公司、医疗器械公司、在线及第三方医疗服务提供商、医疗机构和行业协会。他的执业领域涵盖医疗健康与生命科学企业的全运营周期，包括行业准入、许可交易、研发合规、监管事务、产品上市推广、医务人员互动、药物警戒、不良事件报告、数字健康及医疗事故等。
Jim Qiu serves numerous multinational and domestic healthcare organizations, including biotechnology, pharmaceutical companies, medical device companies, online and third-party medical service providers, healthcare institutions, and industry associations. His practice encompasses the complete operational lifecycle of healthcare and life science enterprises—including industry access, licensing transactions, R&D compliance, regulatory matters, product marketing, healthcare professional interactions, pharmacovigilance, adverse event reporting, digital health, medical malpractice, etc.
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