The technical document review process is a critical step in the National Medical Products Administration (NMPA) certification process for medical devices in China. The review ensures that the device meets the required safety, effectiveness, and quality standards before it can be marketed. Below is a detailed explanation of the various stages and key requirements involved in the technical document review process:

1. Preparation of Required Documents

Before initiating the review process, manufacturers must prepare a comprehensive set of documents. These documents serve as proof that the device complies with Chinese regulatory requirements, including:

• Product Technical File: This includes detailed information about the device, such as design, manufacturing processes, risk management, and performance data.
• Clinical Evaluation Report: For most devices, clinical evidence is required to demonstrate the device’s safety and effectiveness. This report must align with China’s specific requirements, which may differ from those in other regions.
• Test Reports: Laboratory testing data must be submitted to verify the safety and functionality of the medical device. This can include biocompatibility testing, electrical safety, EMC (Electromagnetic Compatibility) testing, and other relevant tests.
• Quality Management System (QMS) Documentation: This includes proof of compliance with a recognized standard such as ISO 13485, which governs medical device manufacturing processes.
• Labeling and Instructions for Use: These must comply with Chinese regulations and language requirements (Chinese language for labeling and packaging).

2. Submission to NMPA

Once the technical documents are compiled, they are submitted to the NMPA. The submission process involves the following steps:

• NMPA Application: The manufacturer or their Chinese agent (a required representative in China) submits the application along with all the technical documentation to NMPA. The submission will be reviewed by the NMPA Medical Device Registration Department.
• Payment of Fees: A submission fee is required, which varies depending on the classification of the device (Class I, II, or III).

3. Preliminary Screening by NMPA

Once the documents are submitted, NMPA will conduct a preliminary screening of the application package. This is to ensure that the application is complete and that all required documents are in place. If any documents are missing or inadequate, NMPA will request corrections or additional information. This phase typically takes a few weeks.

4. Technical Review by NMPA

The NMPA will assign experts from the appropriate technical review division to evaluate the submitted documents. The key aspects reviewed include:

a. Safety and Effectiveness

• Risk Management: The review will assess the risk management documentation (such as FMEA or Hazard Analysis) to evaluate how well the risks associated with the device are controlled.
• Clinical Data: The NMPA will review the clinical evaluation report and any clinical trial data submitted. For high-risk devices (Class III), clinical trials conducted in China may be required. The NMPA will evaluate the data’s relevance to Chinese patient populations.
• Performance Testing: If applicable, the review will verify that the device performs as intended through results from laboratory and in vitro/in vivo testing. This includes electrical safety, biocompatibility, and other testing requirements based on device type.

b. Compliance with Standards

The device must meet the relevant national and international standards. The NMPA will cross-check whether the device complies with Chinese medical device standards, as well as ISO standards. Key standards for medical devices include:

• GB Standards: National standards for medical devices (e.g., GB 9706 for medical electrical equipment).
• IEC Standards: International standards (e.g., IEC 60601 for electrical safety and EMC).
• ISO Standards: Compliance with ISO 13485 for quality management and other ISO standards related to product testing.

c. Manufacturing Processes and Quality Management System

The NMPA evaluates the manufacturing facility’s adherence to quality management system (QMS) requirements. If applicable, an on-site inspection of the manufacturer’s facilities may be conducted, especially for higher-risk devices (Class II and III). The NMPA checks if the company follows GMP (Good Manufacturing Practices) and has an effective quality control system.

d. Labeling and Instructions for Use

The NMPA reviews the product labeling and instructions for use to ensure they are in accordance with Chinese regulations. This includes:

• Product name
• Intended use and indications
• Instructions for use (including Chinese language requirements)
• Warnings and precautions
• Manufacturer details

5. NMPA Expert Review and Consultation

In some cases, especially for high-risk devices (Class III), NMPA may require consultation with external experts. These experts may provide further analysis on clinical data or evaluate whether the device complies with the necessary safety and performance standards.

6. Review Outcome and Further Actions

After completing the technical review, NMPA will issue one of the following decisions:

• Approval: If the device meets all the necessary criteria, NMPA will issue a Medical Device Registration Certificate (CFDA). This allows the device to be marketed in China.
• Conditional Approval: In certain cases, NMPA may approve the device with specific conditions, such as additional clinical studies or post-market surveillance.
• Rejection: If the device fails to meet the necessary standards or if the technical documentation is insufficient, the application may be rejected. The manufacturer will then have the opportunity to address the issues and resubmit the application.

7. Post-Approval Monitoring

Once approved, the manufacturer is required to implement post-market surveillance as part of the regulatory compliance. This involves monitoring the device’s performance in the market and reporting any adverse events or safety concerns to NMPA.

Conclusion

The technical document review process in China’s NMPA certification is a comprehensive and detailed evaluation that ensures medical devices meet stringent safety, effectiveness, and quality standards. Manufacturers must prepare thorough documentation and demonstrate compliance with local regulations to gain approval. By adhering to these guidelines and providing the necessary clinical and technical data, manufacturers can navigate the NMPA review process and successfully obtain the required certifications for marketing in China.