The safety review of medical devices certified by the National Medical Products Administration (NMPA) in China involves a comprehensive evaluation of the device’s safety and performance. Here’s a detailed overview of the standards and technical requirements for this review process:

1. Regulatory Framework

NMPA Standards: The NMPA follows a series of regulations, guidelines, and standards for the safety review of medical devices. The primary regulatory documents include:

• Regulations on the Supervision and Administration of Medical Devices (Decree No. 739).
• Administrative Measures for Medical Device Registration.
• Technical Guidelines for Medical Device Registration.

Chinese National Standards (GB Standards): These standards specify the technical requirements and safety considerations for various types of medical devices. They are often aligned with international standards but may have additional requirements specific to China.

2. Safety Review Criteria

1. Risk Management:

• ISO 14971 Compliance: The device must comply with ISO 14971, which outlines the application of risk management to medical devices. This includes identifying potential hazards, evaluating risks, and implementing measures to mitigate these risks.

2. Clinical Evaluation:

• Clinical Data: The device must be supported by clinical data demonstrating its safety and efficacy. This includes data from clinical trials or literature reviews.
• Clinical Evaluation Report: A detailed report must be submitted, summarizing the clinical evidence supporting the device's safety and effectiveness.

3. Electrical Safety:

• IEC 60601 Compliance: For electrical medical devices, compliance with IEC 60601 standards (e.g., IEC 60601-1 for general safety, IEC 60601-1-2 for EMC) is required to ensure electrical safety and electromagnetic compatibility.

4. Biocompatibility:

• ISO 10993 Compliance: The device must meet the biocompatibility standards outlined in ISO 10993, which assess the biological safety of materials in contact with the body.

5. Manufacturing Quality:

• Good Manufacturing Practice (GMP): Compliance with GMP standards is mandatory. The manufacturing process must be validated to ensure that the device consistently meets safety and quality requirements.

6. Software Validation:

• IEC 62304 Compliance: For devices with software components, adherence to IEC 62304 is necessary to ensure software safety and effectiveness.

3. Technical Documentation Requirements

1. Device Description:

• Detailed technical specifications and descriptions of the device, including its intended use, operating principles, and features.

2. Safety and Performance Data:

• Comprehensive safety and performance data, including pre-clinical and clinical test results.

3. Labeling and Instructions for Use:

• Clear and accurate labeling and instructions, including contraindications, warnings, and user instructions.

4. Risk Analysis:

• Documentation of risk analysis and risk management activities in accordance with ISO 14971.

5. Quality Management System (QMS) Documentation:

• Evidence of a QMS that complies with ISO 13485 or equivalent standards.

4. Review Process

1. Pre-market Review:

• Application Submission: The manufacturer submits a registration application to the NMPA, including all required technical documentation and safety data.
• Document Review: NMPA reviews the submitted documentation for completeness and compliance with regulatory requirements.
• Technical Review: A detailed technical review is conducted to assess the safety, efficacy, and quality of the device.

2. On-site Inspection:

• Factory Inspection: NMPA may conduct on-site inspections of the manufacturing facility to verify compliance with GMP standards and quality control processes.

3. Approval and Certification:

• Certification: Upon successful review, the NMPA issues a registration certificate, allowing the device to be marketed in China.

5. Post-Market Surveillance

1. Vigilance Reporting:

• Manufacturers must report any adverse events or safety issues to the NMPA and take corrective actions as necessary.

2. Post-Market Monitoring:

• Ongoing monitoring of the device’s performance in the market, including tracking of incidents and ensuring continued compliance with safety standards.

Conclusion

The safety review of medical devices by the NMPA in China involves a rigorous evaluation process that includes compliance with international standards, thorough technical documentation, and a comprehensive review of safety and performance data. Manufacturers must ensure that their devices meet all regulatory requirements to obtain certification and maintain ongoing compliance throughout the product lifecycle.