The application steps for NMPA registration in China are:

1. Determine Classification: Confirm that your device is classified correctly (Class I, II, or III).

2. Prepare Documentation: Gather all necessary documents, including:

   • Completed application form.
   • Manufacturer’s business and production licenses.
   • Device specifications, labeling, and packaging details.
   • Clinical data and testing reports.
   • Quality management system (QMS) certification.

3. Submit Application:

   • Online Submission: Register and submit documents through the NMPA’s online platform (https://www.nmpa.gov.cn).
   • Physical Submission: Provide hard copies of the application and supporting documents to the NMPA office.

4. Review Process:

   • Document Review: NMPA reviews for completeness and compliance.
   • Technical Assessment: May involve additional information requests.

5. Testing and Inspection:

   • Testing: Conducted by accredited labs to ensure compliance with Chinese standards.
   • Factory Inspection: NMPA may inspect the manufacturing site.

6. Approval: If approved, receive the NMPA Registration Certificate.

7. Post-Market Requirements: Comply with post-market surveillance, including reporting adverse events and maintaining records.

Make sure to comply with all guidelines and stay updated with NMPA regulations.

Contact Us：

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