2023-07-04-环球律师事务所-医疗器械_中国监管的源头（英）_18页_133kb

The report provides a detailed analysis of the regulatory framework governing medical devices in China, covering key aspects from development and authorization to distribution, use, and interactions with other products, liability, and environmental protection.

Key Regulatory Frameworks

• Product-Specific and General Regulations: Medical devices are regulated under the 2021 Regulations on the Supervision and Administration of Medical Devices and other detailed administrative measures like the Registration and Record-Filing Measures. This applies to development, registration, manufacturing, distribution, and use within China.

Classification and Authorization

• Medical devices are classified into three risk levels:
  • Class I: Low risk, subject to record-filing only.
  • Class II: Medium risk, requires registration.
  • Class III: High risk, requires registration.
• Authorization involves complying with guidelines from the National Medical Products Administration (NMPA), including Good Clinical Practice (GCP) for clinical trials.

Manufacturing, Distribution, and Use

• Manufacturing: Governed by the Measures for the Supervision and Administration of Medical Device Manufacture and Good Manufacturing Practice (GMP).
• Distribution: Regulated by the Measures on Supervision and Administration of Business Operations of Medical Devices and Good Supply Practice (GSP). Online sales require specific permissions.
• Use: Covered by the Measures for the Supervision and Administration of Use Quality of Medical Devices, ensuring proper handling in medical settings.

Interactions with Other Product Categories

• Pharmaceuticals: Separate regulations apply, with combination products (containing both drugs and devices) classified based on primary function under pharmaceutical or device rules.
• Cosmetics: Distinct from medical devices; facial masks are not regulated as devices, only as cosmetics with no claims of medical effects.
• Software: Software that aids diagnosis is part of medical devices, divided into standalone and components, requiring registration.
• Chemicals and Radioactive Materials: Hazardous chemicals are regulated under specific catalogues and permits, while radioactive materials are covered by the 2005 Regulations on Safety and Protection of Radioisotopes.

Liability, Safety, and Legal Protection

• Product Liability: Strict liability applies under the Civil Code for defects, without proving negligence. Contractual and tort liability can coexist.
• Medical Malpractice: Patients can claim compensation from device holders, manufacturers, or institutions, with medical entities recoverable losses.

Health Systems and Public Procurement

• Centralized state or regional procurement governs medical devices, with public hospitals often prioritizing domestic products. Bidding processes must adhere to policies, and large equipment requires licensing.

Cybersecurity, Data Protection, and Export Controls

• Cybersecurity: Compliance with laws like the Cybersecurity Law and Personal Information Protection Law (PIPL) for networked devices handling patient data.
• Export Restrictions: Governed by foreign trade laws, including dual-use items; medical devices listed in controlled lists may require prior approval.

Additional Considerations

• Packaging and Labeling: Requirements include clear instructions, labels, and unique identification; advertising must be truthful and approved by authorities.
• Environmental Protection: Waste management follows environmental laws, including solid waste and medical waste disposal regulations.

This summary captures the primary regulations, classifications, and key areas addressed in the report, highlighting China's comprehensive approach to medical device oversight.