环球律师事务所-医疗器械：中国监管的源头（英）-18页_139kb

Medical Devices Regulation in China

The source of regulation for medical devices in China includes a combination of general and product-specific rules, primarily governed by the 2021 Regulations on Medical Devices under the National Medical Products Administration (NMPA). These regulations classify devices into three risk levels (I, II, III), requiring registration or record-filing based on risk. Key regulatory stages include:

1. Development: Development is controlled by registration measures and clinical trial guidelines (e.g., Medical Device GCP).
2. Manufacturing: Governed by manufacturing measures, GMP, and national standards (e.g., YY 0505-2005).
3. Distribution: Requires compliance with business operation measures, GSP, and online sale-specific rules.
4. Use: Managed by use quality measures and unique identification systems.

Key Cross-Regulatory Areas

• Medical Devices vs. Cosmetics:
  Cosmetics are regulated separately; facial masks are cosmetics, not medical devices. Special cosmetics require registration, while ordinary ones require record-filing.

• Medical Devices vs. Pharmaceuticals:
  Combination products combining medicinal and device functions are categorized by their primary function. If dominated by medicinal effects, they follow pharmaceutical regulations; otherwise, device rules apply.

• Chemicals and Radioactive Materials:
  Hazardous chemicals are subject to the 2013 Chemicals Safety Regulations and permit requirements (e.g., safety use permits). Radioactive materials are regulated by the 2005 Radioactive Materials Regulations, requiring licenses for production/use.

• Software in Devices:
  Medical device software falls into standalone or component categories. It is subject to cybersecurity laws (e.g., Data Security Law, PIPL) and requires network security assessments for connected devices.

Other Regulatory Areas

• Product Liability: Strict liability applies under the Civil Code for defects. Patients can claim compensation from manufacturers, distributors, or medical institutions.
• Export Restrictions: Governed by foreign trade and dual-use technology controls (e.g., Export Control Law, Dual Use Catalogue).
• Environmental Protection: Requires environmental impact assessments and compliance with solid waste/discharge permit laws.
• Advertising: Medical device ads must be truthful, pre-approved, and avoid promoting effects (Permitted under Article 2, 2021 Advertising Law).

Requirements Overview

• Registration Process: Class III: Registration; Class I & II: Record-filing.
• Quality Standards: Mandatory GMP, GSP adherence.
• Documentation: Unique identification, labels, instruction manuals, and cybersecurity reports required.

This summary highlights the framework for medical device regulation in China, emphasizing classification, compliance, and cross-sectoral regulations.