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.
Han Kun has a dedicated life sciences and healthcare team which has been invited multiple times to write the China chapter for the Chambers practice guides in the life sciences and healthcare (medical devices). Han Kun has been consistently ranked as a leading law firm in the life sciences and healthcare sector by authoritative legal directories, including Chambers and Partners, The Legal 500, Asialaw Profiles, and China Business Law Journal. The firm is committed to providing clients in the life sciences and healthcare sector with comprehensive legal services, including private equity and venture capital, mergers and acquisitions, onshore and offshore capital markets, pharmaceutical license in/out, and asset sale/purchase transactions, intellectual property, compliance and regulatory, data protection, and dispute resolution.
