To apply for Class I medical device registration with China NMPA (National Medical Products Administration), you'll typically follow these steps:

1. Classification Determination: Confirm that your device is classified as Class I according to Chinese regulations. Class I devices are typically low-risk and non-invasive.

2. Local Agent Appointment: If you are a foreign manufacturer, appoint a local agent in China who will act as your representative for regulatory purposes.

3. Prepare Technical Documentation: Compile the necessary technical documentation, which may include:

   • Device description and specifications
   • Manufacturing process details
   • Risk assessment documentation
   • Testing reports (if applicable)
   • Instructions for use (IFU)
   • Quality management system documentation (e.g., ISO 13485 certification)

4. Clinical Evaluation: For certain Class I devices, clinical evaluation might be required to demonstrate safety and performance. However, for many Class I devices, this may not be necessary.

5. Submit Application: Prepare and submit your application to the NMPA. The application should include:

   • Application form
   • Technical documentation
   • Quality management system documentation
   • Proof of clinical evaluation (if applicable)

6. Review Process: The NMPA will review your application and may request additional information or clarification during this stage.

7. Approval and Registration: Once your application is approved, you will receive the registration certificate from the NMPA. This certificate allows you to legally market your device in China.

8. Post-Market Surveillance: After registration, ensure compliance with post-market surveillance requirements, including reporting adverse events and maintaining updated technical documentation.

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