To apply for D-class medical device registration with the Saudi Food and Drug Authority (SFDA), you must use the SFDA’s Medical Device Electronic Services (MDES) portal. This is the official online platform for submitting medical device registration applications in Saudi Arabia.

Steps to Apply via MDES Portal:

1. Register an Account on MDES

• To begin the registration process, both local authorized representatives (LARs) and manufacturers (if based in Saudi Arabia) need to have an account on the MDES platform.
• Visit the official MDES portal: MDES Portal.
• Create a New Account: If you or your LAR do not already have an account, you'll need to register and create an account. This requires providing company information and completing any necessary verification steps.

2. Log in to MDES

• Once you have a registered account, log in to the MDES portal using your credentials (username and password).
• You will need the following:
  • LAR Account (for foreign manufacturers) or Manufacturer Account (for local entities).
  • Login credentials (username and password).

3. Complete the Application Form

• After logging in, navigate to the medical device registration section of the platform.
• Select the appropriate application form for D-class medical devices.
• The platform will prompt you to provide details about your device, including:
  • Device Information (name, model, description, and intended use).
  • Manufacturer Details (name, country, and contact information).
  • Local Authorized Representative (if applicable).
  • Quality Management System Information (e.g., ISO certifications).
  • Labeling and Packaging Information (including Arabic and English labels and user manuals).

4. Upload Required Documents

• As part of the application, you will need to upload the following supporting documents:
  • Manufacturer’s Business Registration.
  • Certificate of Free Sale (CFS).
  • ISO 13485 Certification (or equivalent).
  • Declaration of Conformity.
  • Device Labels (in Arabic and English).
  • User Manuals (in Arabic and English).
  • Testing and Certification Reports (if applicable).

These documents must be uploaded in the required formats (PDF, Word, etc.).

5. Pay the Registration Fee

• After completing the application form and uploading the necessary documentation, you will be prompted to pay the registration fee.
• Payment is typically made via the MDES portal using available electronic payment methods (e.g., credit card, bank transfer).

6. Submit the Application

• Once all the required information is filled in and the payment is processed, submit the application through the MDES portal.
• After submission, the SFDA will begin reviewing your application.
• You can track the progress of the application through the portal. If the SFDA requires additional information, you will be notified through the platform.

7. SFDA Review and Approval

• The SFDA will review the application and all supporting documents.
• If the application meets all the necessary requirements, the SFDA will issue the registration certificate for your D-class medical device.
• The registration certificate will be available for download from the MDES portal.

8. Post-Submission Updates

• After approval, your device will be registered, and you must ensure ongoing compliance with SFDA regulations, including post-market surveillance and reporting any adverse events.
• You will also need to renew the registration every 5 years.

Key Points:

• MDES Portal: All submissions for medical device registration in Saudi Arabia must be made through the official MDES portal.
• Local Authorized Representative (LAR): Foreign manufacturers must appoint a local representative to submit the application.
• Electronic Process: The entire registration process (application, payment, submission) is done electronically through the MDES platform.
• Track Application: You can monitor the status of your application and receive notifications directly through the MDES system.