Updating an NMPA-registered medical device in China involves a series of steps and requirements, depending on the nature and extent of the changes. Here's a general overview of the process:

1. Determine the Type of Update

Minor Changes: These are changes that do not affect the device’s safety, effectiveness, or intended use. Examples include minor modifications to labeling or packaging.

Major Changes: These changes affect the device’s safety, effectiveness, or intended use, such as significant design alterations or changes in manufacturing processes.

2. Prepare the Update Documentation

Minor Changes:

• Documentation: Provide detailed documentation of the changes, including revised labeling, instructions for use, or other affected materials.
• Justification: Provide a justification for why the changes are considered minor and do not require a new registration.

Major Changes:

• New Application: Prepare and submit a new registration application if the changes are significant.
• Updated Technical Documentation: Include updated technical documentation, risk analysis, and clinical data if applicable.

3. Submit to NMPA

• Minor Changes: Submit a notification or a simplified application to the NMPA, including all necessary documents.
• Major Changes: Submit a complete new registration application with all required documents and fees.

4. Review and Approval

• NMPA Review: NMPA will review the submitted documents and may request additional information or clarification.
• Inspection: NMPA may require an inspection of the updated device or manufacturing facility.

5. Post-Approval Actions

• Update Records: Update internal records and inform stakeholders about the changes.
• Implement Changes: Ensure that the updated device complies with all applicable regulations and standards.

6. Compliance with Other Regulations

• Quality Management Systems (QMS): Ensure that the changes comply with QMS requirements.
• Labeling and Documentation: Update labeling and other documentation to reflect the changes.

Additional Considerations

• Translation: Ensure that all documents are translated into Chinese.
• Local Representation: If you are not based in China, you may need a local agent or representative to handle the submission process.

If you have specific details about the changes or need further assistance, let me know!

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