英文【Chambers】医疗健康：医疗器械2025

CHAMBERS GLOBAL PRACTICE GUIDESHealthcare: Medical Devices 2025Definitive global law guides offering comparative analysis from top-ranked lawyersChina: Law & Practice Alan Zhou, Coco Fan and Kelly Cao Global Law OfficeCHINA2CHAMBERS.COMLaw and PracticeContributed by: Alan Zhou, Coco Fan and Kelly Cao Global Law OfficeContents1. Applicable Product Safety Regulatory Regimes p.41.1 Medical Devices p.41.2 Healthcare Products p.51.3 Medicines p.51.4 Technologies and Digital Health p.61.5 Borderline Products p.72. Commercialisation and Product Life Cycle p.82.1 Design and Manufacture p.82.2 Corporate Social Responsibility, the Environment and Sustainability p.102.3 Advertising and Product Claims p.102.4 Marketing and Sales p.122.5 Internationalisation p.152.6 Post-Marketing Obligations, Including Corrective Actions and Recalls p.163. Regulator Engagement and Enforcement p.173.1 Regulatory Authorities p.173.2 Regulatory Enforcement Mechanisms p.194. Liability p.194.1 Product Safety Offences p.194.2 Product Liability p.194.3 Judicial Requirements p.204.4 Costs p.204.5 Product-Related Contentious Matters p.204.6 Class Actions, Representative Actions or Co-Ordinated Proceedings p.214.7 ADR Mechanisms p.214.8 Interrelation Between Liability Mechanisms p.215. Applicable Product Safety Regulatory Regimes p.225.1 Policy Development p.225.2 Legislative Reform p.235.3 Impact of Artificial Intelligence p.23CHINA Law and PracticeContributed by: Alan Zhou, Coco Fan and Kelly Cao, Global Law Office 3CHAMBERS.COMGlobal Law Office dates back to the establishment of China’s Legal Consultant Office of the Council for the Promotion of International Trade in 1979. GLO has become one of the largest and leading Chinese law firms, with more than 500 lawyers practising in its Beijing, Shanghai, Shenzhen and Chengdu offices. Its life sciences and healthcare (L&H) practice group was one of the first in China and provides “one-stop” legal services for every area of the industry, including M&A, investment and funding, licence in and out, dai-ly operation, IP protection and advice on compliance, including internal and government investigations, anti-bribery matters and dispute settlement. Under a changing regulatory environment, GLO’s L&H team has the perfect combination of international experi-ence and local know-how to support various inno-vation and pilot projects, including digital healthcare and MAH/CMAH trial cases. The team participates extensively in the formulation of local codes of con-duct and benchmark policies/rules.AuthorsAlan Zhou is the leading partner of the L&H practice group at Global Law Office, and routinely represents multinational corporations, well-known Chinese state-owned and private enterprises, and private equity/venture capital funds in the L&H area. He has been engaged by local authorities and industrial associations to advise on legislation and industry standards in the L&H industry, including the formulation of the compliance guidelines for the h