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What is the processing time for SFDA registration of Class B medical devices?
Release time：2024-09-06 14:57:54 The author: source:
Completeness of Application: A complete and accurate submission can expedite the review process, while incomplete or incorrect applications may cause delays.

The processing time for SFDA registration of Class B medical devices typically ranges from 2 to 6 months. This timeframe can vary based on several factors:

  1. Completeness of Application: A complete and accurate submission can expedite the review process, while incomplete or incorrect applications may cause delays.

  2. Additional Information: Requests for additional information or clarification from SFDA can extend the processing time.

  3. Facility Inspection: If an inspection of the manufacturing facility is required, it may add extra time to the overall process.

  4. Workload and Efficiency: The current workload and efficiency of the SFDA can also impact processing times.

To ensure timely processing, make sure your application is thorough and meets all SFDA requirements. Monitoring the status of your application through the SFDA e-Services portal can help you stay informed of any updates or requests for additional information.

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