To obtain SFDA registration for Class B medical devices in Saudi Arabia, follow these procedures, prepare the required materials, and consider the key factors:

Procedures:

1. Verify Device Classification:

   • Confirm that your device is accurately classified as Class B under SFDA regulations.

2. Prepare Documentation:

   • Gather all required documents and information needed for the application.

3. Register on SFDA Portal:

   • Create an account on the SFDA e-Services portal if you don’t already have one.

4. Submit Application:

   • Complete and submit the online application form via the SFDA e-Services portal. Upload all necessary documents and pay the registration fee.

5. Review and Inspection:

   • SFDA will review your application and may request additional information or conduct an inspection of your manufacturing facility if necessary.

6. Receive Registration:

   • After successful review, SFDA will issue a registration certificate, allowing you to market the device in Saudi Arabia.

7. Post-Market Compliance:

   • Adhere to post-market requirements, including reporting adverse events and conducting post-market surveillance as needed.

Required Materials:

1. Technical Documentation:

   • Device Description: Comprehensive details about the device, including its intended use and operating principles.
   • Design and Manufacturing Information: Information on design, production processes, and quality control.
   • Instructions for Use: User manuals and labeling information.
   • Device Specifications: Performance data and technical specifications.

2. Quality Management System (QMS):

   • ISO 13485 Certification: Proof that your manufacturing facility adheres to ISO 13485 or an equivalent quality management system.

3. Clinical Evidence:

   • Clinical data or performance evaluation reports demonstrating the device’s safety and effectiveness.

4. Risk Management:

   • Risk management documentation outlining identified risks and mitigation measures.

5. Manufacturer Information:

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

6. Labeling and Packaging:

   • Ensure compliance with SFDA labeling requirements, including language and symbol standards.

7. Additional Documentation:

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

Considerations:

1. Compliance with Regulations:

   • Ensure that all documentation and procedures comply with SFDA regulations and guidelines.

2. Accuracy and Completeness:

   • Double-check that all information provided is accurate and complete to avoid delays or rejections.

3. Translation Requirements:

   • Documents may need to be translated into Arabic, depending on SFDA requirements.

4. Fees and Payment:

   • Be aware of the application fees and ensure timely payment to avoid processing delays.

5. Timeframe:

   • Plan for a review period of approximately 2 to 6 months, but be prepared for potential delays, especially if additional information or inspections are required.

6. Consulting Services:

   • Consider consulting with regulatory experts or local representatives to streamline the process and ensure compliance.

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