The duration of the SFDA registration process for Class B medical devices typically ranges from 3 to 6 months. Here’s a breakdown of the timeline:

1. Pre-Application Preparation

• Preparation Time: The time required to prepare the necessary documentation, ensure ISO 13485 certification, and appoint an authorized representative can vary based on your readiness.

2. Application Submission

• Online Application: Completing and submitting the application form through the SFDA e-Services portal is usually done within a few days, depending on the completeness of the submission.

3. Review Stages

• Initial Review: SFDA performs an initial review of the application and documents, which generally takes 1-2 weeks.
• Technical Review: A detailed technical review, including assessment of clinical data and risk management, typically takes 1-3 months. This duration can be longer for more complex devices.
• Inspection (if required): If an inspection of the manufacturing facility is needed, this can add additional weeks to the process.

4. Approval and Post-Approval

• Approval Notification: After completing the review, SFDA will issue a registration certificate. The notification of approval can take an additional few weeks after the technical review.

Factors Affecting Duration

• Completeness of Submission: Ensuring all required documents are complete and accurate can help avoid delays.
• Response Time: Timely responses to any requests for additional information from SFDA can expedite the process.
• Complexity of the Device: More complex devices may require additional time for evaluation.

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