《医疗器械》中国篇（英）

CHAMBERS GLOBAL PRACTICE GUIDESHealthcare: Medical Devices 2024Definitive global law guides offering comparative analysis from top-ranked lawyersChina: Law and 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.51.1 Medical Devices p.51.2 Healthcare Products p.61.3 Medicines p.71.4 Technologies and Digital Health p.81.5 Borderline Products p.92. Commercialisation and Product Life Cycle p.102.1 Design and Manufacture p.102.2 Corporate Social Responsibility, the Environment and Sustainability p.122.3 Advertising and Product Claims p.132.4 Marketing and Sales p.152.5 Internationalisation p.182.6 Post-marketing Obligations, Including Corrective Actions and Recalls p.203. Regulator Engagement and Enforcement p.223.1 Regulatory Authorities p.223.2 Regulatory Enforcement Mechanisms p.234. Liability p.234.1 Product Safety Offences p.234.2 Product Liability p.244.3 Judicial Requirements p.254.4 Costs p.254.5 Product-Related Contentious Matters p.264.6 Class Actions, Representative Actions or Co-ordinated Proceedings p.264.7 ADR Mechanisms p.274.8 Interrelation Between Liability Mechanisms p.275. Applicable Product Safety Regulatory Regimes p.285.1 Policy Development p.285.2 Legislative Reform p.295.3 Impact of Artificial Intelligence p.30CHINA Law and PracticeContributed by: Alan Zhou, Coco Fan and Kelly Cao, Global Law Office 3CHAMBERS.COMGlobal Law Office dates back to the establish-ment 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 scienc-es and healthcare (L&H) practice group is one of the earliest L&H teams in China, having pro-vided “one-stop” legal services for every area of the L&H industry, including M&A, investment and funding, licence in and out, daily operation, IP protection, and advice on compliance includ-ing internal and government investigations as well as anti-bribery matters and dispute settle-ment. Under a changing regulatory environment, GLO’s L&H team has the perfect combination of international experience and local know-how to support various innovation and pilot projects, including digital healthcare and MAH/CMAH trial cases. GLO’s L&H team deeply participates in the formulation of local codes of conduct and benchmark policies/rules.AuthorsAlan Zhou is the leading partner of the life sciences and healthcare (L&H) practice group at Global Law Office, with a strong background in L&H. Mr Zhou 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 i