The license application process for medical device registration in China is governed by the National Medical Products Administration (NMPA). Here's a detailed overview of the steps involved:

1. Classification of the Medical Device

• Determine Classification: Medical devices in China are classified into three categories based on risk:
  • Class I: Low-risk devices (subject to self-declaration).
  • Class II: Moderate-risk devices (require filing and registration).
  • Class III: High-risk devices (require full registration).
• Guidelines: Refer to NMPA's classification guidelines to determine the appropriate class for your device.

2. Pre-application Preparation

• Dossier Preparation: Gather necessary documents, including:
  • Device description.
  • Specifications and intended use.
  • Design and manufacturing processes.
  • Quality management system documentation (e.g., ISO 13485).
• Clinical Data: For Class II and III devices, compile clinical trial data or literature supporting safety and effectiveness.

3. Quality Management System (QMS)

• Implement QMS: Ensure your manufacturing facility complies with ISO 13485 standards or other relevant QMS requirements.
• QMS Certification: Consider obtaining QMS certification from a recognized body, as this may facilitate the registration process.

4. Clinical Trials

• Clinical Evaluation: For higher-risk devices (Class II and III), conduct clinical trials in compliance with NMPA guidelines.
• Approval for Clinical Trials: Obtain approval for clinical trial protocols from the NMPA before proceeding with studies.

5. Filing for Registration

• Submission of Application: Submit the application to the NMPA, which includes:
  • Application form.
  • Device technical documentation.
  • Clinical trial data (if applicable).
  • Quality system documentation.
• Submission Platforms: Applications can be submitted through the NMPA's online platform or via paper-based submissions, depending on the device class.

6. Review Process

• Initial Review: The NMPA conducts an initial review of the submitted documents to ensure completeness.
• Technical Review: A technical review is performed by NMPA experts, focusing on safety, effectiveness, and quality.
• Supplemental Information: Be prepared to provide additional information or clarifications if requested by the NMPA.

7. Approval

• Issuance of Registration Certificate: Upon successful completion of the review process, the NMPA will issue a registration certificate.
• Validity Period: Medical device registrations in China are typically valid for five years, after which renewal is required.

8. Post-market Surveillance

• Adverse Event Reporting: Manufacturers are obligated to monitor and report any adverse events or incidents related to their medical devices.
• Post-market Studies: The NMPA may require post-market studies for some devices to gather additional safety and efficacy data.

9. Renewal and Changes

• Renewal Process: Begin the renewal process six months before the registration expiry.
• Changes in Product: Any significant changes in the product (design, materials, manufacturing process) may require a new registration or supplemental filing.

Additional Considerations

• Consulting Services: Consider engaging local regulatory consultants who specialize in NMPA registration to navigate the complexities of the process effectively.
• Language: Documentation should typically be in Chinese, so translation may be necessary.

Conclusion

The medical device registration process in China involves careful planning, thorough documentation, and adherence to regulatory standards. By understanding each step and preparing accordingly, manufacturers can streamline their application and improve the chances of successful registration.

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