全球知名法律评级机构钱伯斯于近期出版了《钱伯斯医疗健康：医疗器械全球实务指南》（2024年）（“
《指南》
”）。汉坤受邀独家撰写了《指南》“中国篇：趋势与发展”部分，参与撰写的作者包括
顾泱、尤鹏飞、王乐怡和孙舒闻
。继2023年汉坤受邀独家撰写《钱伯斯医疗健康：医疗器械全球实务指南》以来，这是第二次汉坤受邀撰写这一指南的“中国篇：趋势与发展”部分。（请见
汉坤受邀独家撰写《钱伯斯医疗健康：医疗器械全球实务指南》（2023年）中国篇：趋势与发展
）
该《指南》覆盖了全球多个司法辖区，提供关于产品安全监管体系、企业社会责任、环境与可持续发展、广告与产品声明、市场营销与销售、监管机构互动与执法、责任以及人工智能影响的最新法律信息。《指南》“中国篇：趋势与发展”涵盖了医疗器械研发、注册、生产、销售以及上市后警戒等医疗器械全生命周期相关的法规发展趋势，涉及《医疗器械管理法》的立法进展、医疗器械临床试验机构监督检查、人类遗传资源管理、临床实验室自建项目（LDT）、伦理审查、进口医疗器械本地化、临床急需医疗器械进口等多个热点主题，亦包括中国商务部等三部门于2024年9月8日共同发布的《关于在医疗领域开展扩大开放试点工作的通知》，提示其在外商投资人体干细胞、基因诊断与治疗领域方面的影响，为应对医疗器械领域不断变化的法规以及监管实践提供法律实务观察与经验。
汉坤拥有专门从事生命科学和医疗健康业务的律师团队，在该领域具有良好的口碑和声望，曾多次受邀撰写钱伯斯生命科学、医疗健康领域实务指南的中国章节，已连续数年被钱伯斯、The Legal 500、Asialaw Profiles、《商法》等知名法律媒体评为该领域的领先中国律所。汉坤致力于向生命科学与医疗健康行业客户提供包括私募股权和风险投资、兼并和收购、境内外资本市场、授权许可和药品资产交易、知识产权、合规和监管、数据保护及争议解决等在内的全方位法律服务。
Han Kun exclusively authors the China chapter (Trends and Developments) of Chambers Healthcare: Medical Devices Global Practice Guide (2024)
The world's leading legal directory Chambers and Partners recently published its Healthcare: Medical Devices Global Practice Guide (2024) (the "
Guide
"). Han Kun exclusively contributed the China chapter (Trends and Developments) of the Guide. The contributors include
Yang (Aaron) Gu, Pengfei You, Leyi Wang, and Shuwen Sun
. Following Han Kun’s contribution to the Chambers Healthcare: Medical Devices Global Practice Guide (2023), this is the second time that Han Kun has been invited to write the China chapter (Trends and Developments) of Chambers Healthcare: Medical Devices Global Practice Guide. (Please refer to the
Han Kun exclusively authors the China Trends & Developments section of the Chambers Global Practice Guide Healthcare: Medical Devices 2023
)
The Guide features more than a dozen jurisdictions and provides the latest legal information on product safety regulatory regimes, corporate social responsibility (CSR), the environment and sustainability, advertising and product claims, marketing and sales, regulator engagement and enforcement, liability and the impact of AI. The China chapter (Trends and Developments) of the Guide covers the regulatory trends related to the entire lifecycle of medical devices, including research and development, registration, manufacturing, distribution, and post-marketing vigilance. It addresses important topics such as legislation of the Medical Device Administrative Law, supervision and inspection of medical device clinical trial sites, human genetic resources, laboratory-developed tests (LDT), ethical reviews, localisation of imported medical devices, and the temporary importation of medical devices urgently needed for clinical use. It also includes the Notice on Carrying Out Pilot Programs to Expand Opening-Up in the Healthcare Sector which was jointly issued on September 8, 2024 by the Ministry of Commerce of China, together with China’s National Health Commission and National Medical Products Administration, highlighting the impact on foreign investment in China in areas such as human stem cells, gene diagnosis and therapy. The China chapter (Trends and Developments) of the Guide provides legal insights and practical experience to respond to the continually changing regulations and regulatory practices in the medical device sector in China.
