To apply for B-class medical device registration with the Saudi Food and Drug Authority (SFDA), you need to submit your application through the SFDA’s online system, which is the Medical Device Electronic System (MDES). This system is the official platform for registering medical devices in Saudi Arabia and handling related processes.

Steps to Apply for B-Class Medical Device Registration with SFDA

1. Create an Account on the MDES Portal

• Website: The application must be submitted through the MDES Portal: https://mdes.sfda.gov.sa.
• If you don’t already have an account, you need to create one by registering on the MDES platform. The system requires users to have a registered account to access the application forms, submit documents, and track the status of the application.

2. Access the Medical Device Registration Section

• After logging in to the MDES portal, navigate to the Medical Device Registration section.
• Here, you will be able to create a new registration application for your B-class medical device.

3. Submit the Required Documentation

• Upload all the required documentation related to your device, including:
  • Device description and intended use.
  • Risk management documentation.
  • Conformity assessment reports.
  • Clinical data (if applicable).
  • Labeling and instructions for use (IFU).
  • Quality Management System (QMS) certification (e.g., ISO 13485).
  • Manufacturing site details.
  • Declaration of Free Sale (if applicable).
• Ensure that all documents are complete and meet SFDA’s requirements.

4. Pay Registration Fees

• The SFDA charges a registration fee, which can be paid directly through the MDES portal using various payment methods, such as credit cards or bank transfers. The fee is based on the device classification and the submission complexity.

5. Track the Application Status

• After submission, you can track the status of your application in the MDES portal.
• SFDA may request additional information or clarification, so keep an eye on any updates or requests.

6. Final Approval and Registration

• Once SFDA reviews and approves the application, they will issue a registration certificate for your B-class medical device, allowing it to be marketed in Saudi Arabia.

Additional Notes

• Local Authorized Representative: If you are a manufacturer based outside Saudi Arabia, you must have a local authorized representative in Saudi Arabia who will submit the application on your behalf.
• Language: The application process and documentation should be available in both Arabic and English, so ensure that your documents meet the language requirements.
• Post-Submission: After submission, SFDA may request additional documents or clarifications. Ensure that your contact information is up to date for smooth communication with the SFDA.

Conclusion

To apply for B-class medical device registration in Saudi Arabia, submit your application through the MDES portal. This is the official platform for medical device registration in the country. Ensure you have all the required documentation and comply with SFDA’s regulations to facilitate the approval process.

Let me know if you need help with any specific part of the application!