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How to apply for SFDA registration for Class B medical devices in Saudi Arabia?
Release time：2024-09-06 14:51:56 The author: source:
Determine Classification: Ensure your device is classified as Class B according to SFDA regulations.

To apply for SFDA registration for Class B medical devices in Saudi Arabia, follow these steps:

  1. Determine Classification: Ensure your device is classified as Class B according to SFDA regulations.

  2. Prepare Documentation:

    • Technical File: Include product specifications, design and manufacturing details.
    • Quality Management System: Provide ISO 13485 certification.
    • Clinical Evidence: Submit clinical data or performance evaluation.

  3. Create an Account: Register on the SFDA’s online portal (Saudi FDA e-Services).

  4. Submit Application: Fill out the application form on the SFDA portal, upload all required documents, and pay the application fee.

  5. Review Process: SFDA will review your submission. Be prepared to respond to any additional information requests.

  6. Inspection: If needed, SFDA may conduct an inspection of your facility.

  7. Receive Registration: After successful evaluation, SFDA will issue a registration certificate, allowing market access.

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