To apply for Class D medical device registration with the Saudi Food and Drug Authority (SFDA), you will use the SFDA's electronic submission system. Here’s a step-by-step guide on how to apply:

Application Process

1. Prepare Documentation

   • Gather all required documents, including the technical file, clinical data, risk management report, proof of compliance with international standards, labeling, and instructions for use.

2. Create an SFDA Account

   • Register on the SFDAsystem: If you don’t have an account, you need to create one. Visit the SFDA’s official website and access the SFDAsystem portal to register.

3. Access the SFDAsystem Portal

   • Login: Use your credentials to log in to the SFDA’s electronic submission system, known as the SFDAsystem.

4. Complete the Application Form

   • Fill Out Form: Complete the application form for Class D medical devices, which is available within the SFDAsystem portal.

5. Upload Required Documents

   • Technical Documentation: Upload the technical file, clinical data, risk management report, and other required documents.
   • Labeling and Instructions: Include product labeling and instructions for use.
   • Proof of Compliance: Attach certificates or proof of compliance with relevant international standards.

6. Pay Registration Fees

   • Fee Payment: Pay the applicable registration fees through the SFDA’s payment system, which is integrated into the SFDAsystem.

7. Submit the Application

   • Review and Submit: Review all submitted information for accuracy and completeness before final submission.

8. Monitor Application Status

   • Track Progress: Use the SFDAsystem to track the status of your application and respond to any requests from the SFDA for additional information or clarification.

9. Respond to Queries

   • Additional Information: If the SFDA requests further information or clarification, respond promptly to avoid delays.

10. Receive Approval

    • Registration Certificate: Once the SFDA completes their review and is satisfied with the documentation, they will issue a registration certificate.

Where to Apply

• SFDA Official Website: The primary platform for registration is the SFDAsystem portal, accessible through the SFDA’s official website.

  • SFDA Website: https://www.sfda.gov.sa
  • SFDAsystem Portal: Navigate to the SFDAsystem portal via the SFDA website for electronic submission and application tracking.

Additional Tips

• Consult SFDA Guidelines: Regularly review the SFDA’s guidelines and requirements for Class D medical devices to ensure compliance with all regulations.
• Professional Assistance: Consider engaging with a regulatory affairs consultant who is experienced with SFDA procedures to help streamline the application process.

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