Registering a Class II medical device with the NMPA (National Medical Products Administration) in China involves several key steps. Here’s a detailed guide to help you through the process:

1. Determine Device Classification

1.1 Classification Confirmation:

• Confirm that the device falls into Class II based on its risk level and intended use according to Chinese regulations.

2. Prepare Required Documentation

2.1 Application Form:

• Complete the NMPA application form for Class II medical devices.

2.2 Product Description:

• Provide a detailed description of the device, including its intended use, design, specifications, and performance characteristics.

2.3 Technical Documentation:

• Design and Manufacturing Information: Detailed information on the device’s design, manufacturing process, and quality control measures.
• Risk Management Documentation: Include risk assessment and management documentation.
• Clinical Data: Clinical trial data might be required, particularly if there is no existing data or if the device is novel or has significant variations.
• Quality Management System (QMS) Certification: Proof of compliance with QMS standards (e.g., ISO 13485).
• Product Testing Reports: Provide reports from accredited testing laboratories demonstrating compliance with Chinese standards for performance, safety, and biocompatibility.

2.4 Labeling and Instructions:

• Include translations of the device’s labeling, instructions for use, and other relevant user information into Chinese.

3. Submission Process

3.1 Online Submission:

• Submit the application and supporting documents through the NMPA’s online submission system.

3.2 Physical Submission:

• Provide physical copies of the application and documents to the NMPA office if required.

4. Review and Evaluation

4.1 Initial Review:

• NMPA will review the application for completeness and adherence to regulatory requirements.

4.2 Technical Review:

• The NMPA will perform a detailed review of the technical documentation, including performance and safety data.

4.3 On-site Inspection:

• An inspection of the manufacturing facility may be required to ensure compliance with Good Manufacturing Practices (GMP).

4.4 Clinical Trial Review:

• Evaluate clinical data submitted with the application. Additional clinical trials in China may be required depending on the device.

5. Fees

5.1 Application Fee:

• Pay the application fee, which varies depending on the type and complexity of the device.

5.2 Review Fee:

• Additional fees for the review process.

5.3 Testing Fees:

• Fees related to product testing and inspections if applicable.

6. Approval and Issuance

6.1 Approval Notification:

• Once the review process is complete and all requirements are met, you will receive an approval notification from the NMPA.

6.2 Issuance of Certificate:

• The NMPA will issue the registration certificate for the Class II medical device.

7. Post-Approval Requirements

7.1 Regulatory Compliance:

• Ensure ongoing compliance with Chinese regulations and standards.

7.2 Reporting Obligations:

• Report any adverse events or issues related to the device to the NMPA as required.

7.3 Renewal and Updates:

• Periodically renew the registration certificate as required and submit applications for significant changes or updates to the device.

8. Additional Considerations

8.1 Local Representation:

• Engage a local regulatory consultant or agent to facilitate the registration process.

8.2 Translation:

• Ensure that all documents are accurately translated into Chinese.

8.3 Regulatory Changes:

• Stay informed about changes in NMPA regulations and guidelines to ensure compliance.

If you need more specific details or assistance with any part of the process, let me know!

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