To apply for SFDA registration for Class B medical devices, the following conditions must be met:

1. Device Classification:

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

2. Technical Documentation:

   • Device Description: Provide a detailed description of the device, including its intended use and functionality.
   • Design and Manufacturing Details: Include information about the design process, manufacturing procedures, and quality control measures.
   • Instructions for Use: Submit clear and comprehensive user manuals and labeling.

3. Quality Management System (QMS):

   • ISO 13485 Certification: Your facility must have ISO 13485 certification or an equivalent quality management system certification.

4. Clinical Evidence:

   • Clinical Data: Present relevant clinical data or performance evaluation reports demonstrating the safety and effectiveness of the device.

5. Risk Management:

   • Risk Management Documentation: Provide a risk management file detailing the identified risks and mitigation strategies.

6. Manufacturer Information:

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

7. Labeling and Packaging:

   • Ensure that the device labeling and packaging comply with SFDA regulations, including language requirements (Arabic and English) and relevant symbols.

8. Additional Documentation:

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

9. Compliance with SFDA Regulations:

   • Adhere to all SFDA requirements and guidelines relevant to medical device registration.

10. Online Registration:

    • SFDA e-Services Portal: Complete the application process through the SFDA e-Services portal, including submission of all required documents and payment of fees.