When evaluating medical devices for NMPA (National Medical Products Administration) certification in China, several criteria are considered to ensure safety, effectiveness, and quality. Here’s an overview of the key evaluation criteria:

1. Safety and Effectiveness

• Clinical Evidence: For Class II and III devices, provide clinical data demonstrating the device's safety and effectiveness. This includes clinical trial results and post-market surveillance data.
• Risk Assessment: Conduct a comprehensive risk assessment identifying potential hazards and mitigating measures.

2. Technical Specifications

• Design and Manufacturing: Detailed description of the device's design, intended use, and manufacturing processes. This includes material specifications and performance characteristics.
• Testing Data: Results from preclinical and clinical tests, including biocompatibility, electrical safety, and functional performance.

3. Quality Management System (QMS)

• GMP Compliance: Adherence to Good Manufacturing Practice (GMP) standards. Evidence of a robust quality management system covering all aspects of production and quality control.
• Documentation: Proper documentation of quality management procedures, including production controls, supplier management, and complaint handling.

4. Regulatory Compliance

• Labeling and Instructions: Compliance with Chinese labeling requirements, including product labels, instructions for use, and packaging materials in Chinese.
• Registration Documentation: Complete and accurate submission of all required registration documents, including technical files, clinical data, and supporting evidence.

5. Risk Management

• Risk Management Plan: A plan outlining how risks are identified, assessed, and mitigated throughout the device lifecycle.
• Post-Market Surveillance: Procedures for monitoring device performance and reporting adverse events after market introduction.

6. Device Classification

• Appropriate Classification: Correct classification of the device (Class I, II, III) according to its risk level. Each class has specific requirements and levels of scrutiny.

7. Compliance with Local Regulations

• Regulatory Guidelines: Adherence to NMPA’s specific technical guidelines and standards for different types of medical devices.
• Clinical Trial Approval: For devices requiring clinical trials, compliance with local regulations and obtaining necessary approvals.

8. Manufacturing Facility

• Inspection: Manufacturing facilities may be subject to inspections to ensure they meet NMPA’s GMP requirements.
• Facility Certification: Certification of the manufacturing facility in accordance with local and international standards.

9. Intellectual Property

• Patent Status: Verification of intellectual property rights and patents, ensuring that the device does not infringe on existing patents.

Evaluation Process

1. Document Review: NMPA reviews all submitted documentation, including technical files, clinical data, and quality management systems.
2. Technical Evaluation: Involves a detailed assessment of the device’s technical specifications and performance data.
3. Inspection: On-site inspections of manufacturing facilities and clinical trial sites (if applicable) may be conducted.
4. Approval Decision: Based on the evaluation, NMPA decides whether to approve the device for market entry.

Useful Links

For further details on evaluation criteria and guidelines, visit the NMPA Official Website. Consulting with regulatory experts can also provide valuable insights and assistance throughout the evaluation process.