医疗保健设备2023之中国篇（英）-30页_923kb

CHINA Law and Practice: Healthcare and Medical Devices

Global Law Office (GLO) authored this guide, providing a comprehensive analysis of China's legal landscape for healthcare, medical devices, pharmaceuticals, and related products, including cosmetics, foods, stem cells, and digital health technologies.

Key Areas Covered:

1. Product Classification and Regulation:

   • Medical Devices: Categorized into Class I (low risk, filing), II (medium, license), and III (high, license) per the National Medical Products Administration (NMPA), impacting registration/approval processes.
   • Healthcare Products: Includes requirements for cosmetics (new system), biocides (pesticide-like control), and food (general regulations for conventional, specific for health foods/GMOs).
   • Medicines: Governed by the Drug Administration Law (DAL) across development, registration, manufacturing (GMP), distribution, and advertising approval (SAMR).
   • Special Cases: Covers blood products (strict control), psychedelics, CBD products, stem cell technology (foreign investment banned), and specific digital health tools (e.g., medical apps, wearables).

2. Commercialization and Life Cycle:

   • Requirements: Includes design, GMP compliance, manufacturing permits/approvals, outsourcing, contracts, and record-keeping.
   • Advertising & Claims: Strict rules exist for accuracy, avoiding false claims, and obtaining prior approval for device and drug ads, with special restrictions for certain products.
   • Clinical Evaluation: Necessities for devices exist unless exempted. Registration/record-keeping varies by device type (Class III to Class I).
   • Distribution: Governed by GSP and permits licenses, with scrutiny on online sales and transactions affecting the Greater Bay Area.

3. Regulatory Engagement & Enforcement:

   • Authorities: National and local State Administration for Market Regulation (SAMR) oversee quality safety, operations, anti-bribery (overall); NMPA (under SAMR) handles registration, post-market management; National Health Commission (NHC) manages healthcare services and national drug policy; Ministry of Public Security (PSB) handles control of narcotics/psychotropics. Other bodies like MOST (human genetic resources) may intervene.
   • Mechanisms: Antitrust review, consumer rights protection, administrative enforcement, and court actions/fine collection.

4. Liability & Dispute Resolution:

   • Civil Liability: Contract/medical device claims governed by general law and product liability principles (manufacturer/distributor responsibility for defects). Personal Injury lawsuits grant court discretion and data experts access.
   • Criminal Liability: Corporate leaders may face criminal liability under environmental or negligence-related failures.
   • ADR Mechanisms: Court trials can be civil or public interest actions ("consumer representative action"); enterprises are encouraged/can adopt regulatory ADR processes. Streamlined penalties and trial referral frameworks exist between agencies.
   • Judicial Review/Prosecutorial Supervision: Specific administrative acts can be challenged in court. Procuratorates play a key role in overseeing corporate compliance through "Corporate Compliance Reform."

5. Policy Development & Legislative Reform:

   • Recent laws targeting medical devices (new RSAMD), cosmetics (revisions), food safety, environmental protection (new ecological law), stem cell regulation, human genetic resources (new Implementing Rules), and AI development are shaping the field. Ongoing legislative plans anticipate further adjustments.

Authors:

• Alan Zhou (Leading Partner, Healthcare Law)
• Coco Fan, Kelly Cao, Sylvia Dong (Partners/Of Counsel in life sciences, compliance, dispute, M&A/VC sectors)

Conclusion:
The guide aims to provide expert legal commentary for businesses navigating China's complex healthcare and medical device regulations, offers trend forecasts, and compares regulations across jurisdictions through the lenses of leading lawyers at GLO.