To obtain SFDA registration for Class B medical devices in Saudi Arabia, you need to meet several key requirements:

1. Classification Confirmation:

   • Verify that your device is correctly classified as Class B according to SFDA guidelines.

2. Technical Documentation:

   • Device Description: Detailed information about the device, its intended use, and operating principles.
   • Design and Manufacturing Information: Documentation on the design, production processes, and quality control measures.
   • Instructions for Use: Clear and comprehensive user manuals and labeling.
   • Device Specifications: Technical data and performance specifications.

3. Quality Management System (QMS):

   • ISO 13485 Certification: Ensure that your facility has an ISO 13485 certificate or an equivalent quality management system certification.

   
   

4. Clinical Evidence:

   • Provide clinical data or performance evaluation reports to demonstrate the safety and effectiveness of the device.

5. Risk Management:

   • Include a risk management file that outlines the risks associated with the device and the measures taken to mitigate them.

6. Manufacturer Information:

   • Business Registration: Proof of legal status and business registration of the manufacturer.
   • Authorized Representative: If the manufacturer is located outside Saudi Arabia, appoint an authorized representative within Saudi Arabia.

7. Labeling and Packaging:

   • Ensure that the device labeling complies with SFDA regulations, including language requirements and relevant symbols.

8. Registration Application:

   • Online Submission: Register and submit your application through the SFDA e-Services portal.
   • Fees: Pay the applicable registration fee as specified by SFDA.

9. Additional Documentation:

   • Certificate of Free Sale: If applicable, provide a certificate indicating that the device is legally marketed in another country.
   • Manufacturing License: Provide a copy of the manufacturing license or equivalent from the country of origin.

10. Post-Market Requirements:

    • Be prepared to comply with post-market surveillance, including reporting adverse events and conducting periodic updates or renewals as required by SFDA.

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