医疗健康：医疗器械2025

Definitive global law guides offeringcomparative analysis from top-ranked lawyers China: Law & PracticeAlan Zhou, Coco Fan and Kelly CaoGlobal Law Office CHINA Law and Practice Contributed by:Alan Zhou, Coco Fan and Kelly CaoGlobal Law Office Contents 1. Applicable Product Safety Regulatory Regimesp.4 1.1Medical Devices p.41.2Healthcare Products p.51.3Medicines p.51.4Technologies and Digital Health p.61.5Borderline Products p.7 2. Commercialisation and Product Life Cyclep.8 2.1Design and Manufacture p.82.2Corporate Social Responsibility, the Environment and Sustainability p.102.3Advertising and Product Claims p.102.4Marketing and Sales p.122.5Internationalisation p.152.6Post-Marketing Obligations, Including Corrective Actions and Recalls p.16 3. Regulator Engagement and Enforcementp.17 3.1Regulatory Authorities p.173.2Regulatory Enforcement Mechanisms p.19 4. Liabilityp.19 4.1ProductSafetyOffencesp.194.2Product Liability p.194.3Judicial Requirements p.204.4Costs p.204.5Product-Related Contentious Matters p.204.6Class Actions, Representative Actions or Co-Ordinated Proceedings p.214.7ADR Mechanisms p.214.8Interrelation Between Liability Mechanisms p.21 5. Applicable Product Safety Regulatory Regimesp.22 5.1Policy Development p.225.2Legislative Reform p.235.3ImpactofArtificialIntelligencep.23 CHINALaw and Practice Contributed by:Alan Zhou, Coco Fan and Kelly Cao,Global Law Office ly operation, IP protection and advice on compliance,includinginternal and government investigations,anti-bribery matters and dispute settlement. Undera changing regulatory environment, GLO’s L&H teamhas the perfect combination of international experi-ence and local know-how to support various inno-vation and pilot projects, including digital healthcareand MAH/CMAH trial cases. The team participatesextensively in the formulation of local codes of con-duct and benchmark policies/rules. Global Law Officedates back to the establishmentof China’s Legal Consultant Office of the Council forthe Promotion of International Trade in 1979. GLOhas become one of the largest and leading Chineselaw firms, with more than 500 lawyers practising in itsBeijing, Shanghai, Shenzhen and Chengdu offices.Its life sciences and healthcare (L&H) practice groupwas one of the first in China and provides “one-stop”legal services for every area of the industry, includingM&A, investment and funding, licence in and out, dai- Authors Coco Fanis a partner in the L&Hpractice group at Global Law Office,specialising in corporate, compliance,private equity and venture capital,and M&A. Her rich experience in theL&H practice includes prescription Alan Zhouis the leading partner ofthe L&H practice group at Global LawOffice, and routinely representsmultinational corporations, well-known Chinese state-owned andprivate enterprises, and private equity/venture capital funds in the L&H area. He hasbeen engaged by local authorities and industrialassociations to advise on legislation and industrystandards in the L&H industry, including theformulation of the compliance guidelines for thehealthcare industry, the textbook for CorporateCompliance Officer Professional Skill Standards,e-healthcare, medical insurance reform and medicalrepresentative administration. Mr Zhou isconsistently ranked by Chambers and Partners, andis a published author. medicine, over-the-counter medicine, contractresearch organisations, medical devices,biopharmaceuticals, health foods, clinical supply,vaccines, animal health and hospitals. Ms Fan hasadvised many multinational companies, privatecompanies and investors on risk assessment andhealth checks, and has tailored training regardinganti-corruption, antitrust, promotion and otherregulatory compliance. She also advises on theestablishment of pharmaceutical and medical deviceindustry compliance management standards. Kelly Caois a partner in the L&Hpractice group at Global Law Office.Her main practice areas encompassdispute resolution, compliance andrisk control, as well as labour andemployment. Ms Cao has advisedmajor life sciences companies on general compliance and dispute resolution, and assistsmultinational enterprises and well-known domesticenterprises with their disputes in litigation andarbitration. She also provides legal services tomultinational pharmaceutical corporations, assistingwith their compliance system establishment andinternal compliance investigations. CHINALaw and Practice Contributed by:Alan Zhou, Coco Fan and Kelly Cao,Global Law Office Global Law Office 36th FloorShanghai One ICCNo 999 Middle Huai Hai RoadXuhui DistrictShanghai 200031China Tel: +86 212 310 8200Fax: +86 212 310 8299Email: alanzhou@glo.com.cnWeb: www.glo.com.cn 1. Applicable Product SafetyRegulatory Regimes tion (NMPA) determines a medical device’s risk levelaccording to its intended purposes, its structural fea-tures, the form of use, whether it is in contact with orhas access to the human body, and other factors. Ingeneral: 1.1Medical D