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

Application Process

1. SFDA Portal: The registration process is handled through the SFDA's electronic registration system known as the SFDA Electronic Submission System (SFDAsystem).

2. Creating an Account:

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

3. Prepare Documentation:

   • Technical File: Ensure you have all necessary documentation ready, including the device’s technical file, clinical data, risk management report, proof of compliance with international standards, and labeling.

4. Submit Application:

   • Log In: Log into your account on the SFDA’s electronic system.
   • Complete Application: Fill out the application form for Class D medical devices and upload all required documents.
   • Pay Fees: Pay the applicable registration fees through the SFDA’s payment system.

5. Track Application:

   • Monitor Status: After submission, you can track the status of your application through the SFDA’s electronic system.

6. Respond to Queries:

   • Additional Information: The SFDA may request additional information or clarification during the review process. Ensure timely responses to any such requests.

Contact Information

• SFDA Website: SFDA Official Website
• SFDAsystem Portal: Access the SFDAsystem portal through the SFDA’s website for electronic registration.

Tips

• Consult Guidelines: Review the SFDA’s specific guidelines for Class D medical devices to ensure compliance with all requirements.
• Professional Assistance: Consider working with a regulatory affairs consultant to navigate the process effectively.

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