To apply for A-class medical device registration with the Saudi Food and Drug Authority (SFDA), you need to submit your application through the SFDA Medical Devices Electronic Registration System (MDES).

Where to Apply:

• SFDA MDES Portal: The application for medical device registration is done online through the official SFDA portal.
  • Portal Link: MDES Portal
  This is the online platform where manufacturers and their authorized representatives can submit registration applications, track progress, and manage their medical device registration status.

Steps to Apply via MDES Portal:

1. Create an Account on MDES:

   • If you don't already have an account, you must create one. You can do so by visiting the SFDA MDES portal and following the registration steps to set up a user account.
   • Authorized Representative: If you're a foreign manufacturer, ensure that your authorized representative in Saudi Arabia has an account on the MDES portal. They will need to handle the submission process on your behalf.

2. Log In to the Portal:

   • Once your account is set up (or if you're an authorized representative, you’ve been granted access), log in to the MDES portal to begin the registration process.

3. Submit Your Application:

   • After logging in, navigate to the section for medical device registration and select the option to apply for an A-class device.
   • You will be asked to upload all required documents (such as device description, manufacturing information, labeling, Certificate of Free Sale, etc.) in the appropriate sections of the application form.

4. Pay Registration Fees:

   • The portal will guide you through the payment process. Registration fees for A-class devices typically range from SAR 5,000 to SAR 10,000 (approx. USD 1,300 to USD 2,600).

5. Submit and Track:

   • Once you’ve filled out all sections and paid the necessary fees, you can submit the application.
   • You will be able to track the status of your application through the MDES portal. If SFDA requires additional information or clarification, they will communicate through the portal.

6. Receive Approval:

   • If the SFDA approves your application, you will receive a registration certificate through the portal. This certificate allows you to legally market your device in Saudi Arabia.

Other Key Information

• Local Authorized Representative: If your company is outside Saudi Arabia, your local authorized representative in Saudi Arabia will need to manage the registration process on the MDES portal. They will be the primary point of contact between you and SFDA.
• SFDA Contact Information: If you need assistance or have specific questions about the MDES portal or the registration process, SFDA has a customer service section on their website, and they can be contacted for support.

Additional Resources:

• SFDA Website: www.sfda.gov.sa
  • The SFDA website contains guidelines, FAQs, and more detailed information about medical device registration.

Would you like further assistance with navigating the MDES portal or preparing the necessary documents for submission?

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