The license application process for NMPA (National Medical Products Administration) registration of medical devices in China involves several key steps. Here’s an overview of the typical process:

1. Preparation

• Understand Requirements: Review NMPA regulations and guidelines relevant to medical device registration.
• Classify the Device: Determine the appropriate classification (Class I, II, or III) of your medical device, as this affects the application process.

2. Documentation and Material Preparation

• Gather Required Documents: Collect and prepare all necessary documentation, including:
  • Application form
  • Company business license
  • QMS certification (e.g., ISO 13485)
  • Device description, specifications, and labeling
  • Technical documentation (design, risk management, pre-clinical testing)
  • Clinical data (evaluation reports, clinical trial reports)
  • Manufacturing process and site information
• Translate Documents: Ensure all documents are translated into Chinese by a certified translator.

3. Submission

• Prepare Submission Package: Organize all documents according to NMPA guidelines.
• Submit Application: Submit the application package through the NMPA online submission system or as instructed by NMPA.

4. Review and Approval

• Fee Payment: Pay the registration fees based on device classification and keep proof of payment.
• NMPA Review: The NMPA reviews the application and may request additional information or clarification.
• Respond to Queries: Address any requests for additional information promptly to avoid delays.

5. Approval and Certification

• Receive Certificate: Upon successful review, NMPA issues a registration certificate for the device.
• Post-Market Surveillance: Comply with ongoing regulatory requirements, including post-market monitoring and reporting.

6. Renewal and Maintenance

• Renew Certification: Monitor the validity of your registration and apply for renewal as required.
• Maintain Compliance: Adhere to NMPA regulations for quality management, safety, and performance throughout the device’s lifecycle.

This overview provides a structured approach to obtaining NMPA registration, helping you navigate the process efficiently.