The NMPA (National Medical Products Administration) certificate application process in China for medical devices involves several key steps. Here’s a detailed guide:

1. Determine Device Classification

Classification Categories:

• Class I: Low risk, subject to registration with local health authorities.
• Class II: Moderate risk, requires special registration.
• Class III: High risk, requires more stringent registration and clinical trials.

2. Prepare Required Documentation

General Documentation:

• Application Form: Complete and sign the NMPA application form.
• Product Description: Detailed description of the device, including intended use and specifications.
• Technical Documentation: Design, manufacturing process, and risk management documentation.
• Clinical Data: Clinical trial data if applicable (more critical for Class II and III).
• Quality Management System (QMS) Certification: Proof of QMS certification, such as ISO 13485.
• Labeling and Instructions: Chinese translations of the device’s labeling, instructions for use, and other relevant materials.

Specific Documentation:

• Clinical Trial Reports: Required for Class II and III devices if the device has not been previously tested in China.
• Manufacturing License: Proof that the manufacturing facility meets NMPA standards.
• Product Testing Reports: Test reports from accredited labs.

3. Submit the Application

Submission Process:

• Online Submission: Use the NMPA's online submission system to submit the application and documents.
• Physical Submission: Submit physical copies of the application and supporting documents to the NMPA office if required.

4. Pay Fees

Fees Include:

• Application Fee: Varies based on device classification and type.
• Review Fee: Additional fee for the review process.
• Testing Fees: If additional testing is required.

5. Review and Evaluation

Review Process:

• NMPA Review: The NMPA will review the submitted documents and may request additional information or clarification.
• On-site Inspection: An inspection of the manufacturing facility may be conducted if required.
• Clinical Trial Review: If applicable, the results of clinical trials will be reviewed.

6. Approval and Issuance

Approval Process:

• Approval Notification: Upon successful review, you will receive an approval notification.
• Issuance of Certificate: The NMPA will issue the medical device registration certificate.

7. Post-Certification Requirements

Compliance:

• Compliance with Regulations: Ensure that the device complies with all Chinese regulations and standards.
• Reporting: Report any adverse events or issues related to the device to the NMPA.

Renewal and Updates:

• Renewal: Renew the registration certificate as required.
• Updates: Submit applications for any significant changes or updates to the device.

Additional Tips

• Local Representation: Consider working with a local regulatory consultant or agent to assist with the application process.
• Translation: Ensure that all documents are accurately translated into Chinese.
• Regulatory Guidance: Regularly review NMPA guidelines and updates to stay compliant with changing regulations.

If you need more specific details or have further questions, feel free to ask!

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