Process and Steps for Registering a B-Class Medical Device with Saudi SFDA

The Saudi Food and Drug Authority (SFDA) regulates the registration of medical devices in Saudi Arabia to ensure safety and effectiveness. The registration process for B-class medical devices is a structured procedure that involves several key steps. Below is a detailed guide on how to register a B-class medical device with the SFDA.

Step 1: Verify the Classification of Your Device

Before beginning the registration process, ensure your device is correctly classified as Class B. The SFDA classifies medical devices into four categories: Class A (low risk), Class B (moderate risk), Class C (high risk), and Class D (high risk for life-supporting devices). B-class devices are those that present moderate risk to patients or users, such as diagnostic equipment, some surgical instruments, and therapeutic devices.

How to verify:

• Consult the SFDA Medical Device Classification Guidelines to determine if your device meets the criteria for Class B.
• If in doubt, you can request a classification opinion from the SFDA or consult a regulatory expert.

Step 2: Appoint an Authorized Representative (if applicable)

If your company is located outside Saudi Arabia, you are required to appoint a local authorized representative in Saudi Arabia. This representative will act as the point of contact between your company and SFDA.

• Responsibilities of the authorized representative:
  • Submit and manage the registration application.
  • Act as the liaison with SFDA for communication regarding regulatory issues.

Step 3: Prepare the Required Documentation

Prepare the necessary documentation to submit with your registration application. The required documents generally include:

1. Device Description:

   • A clear and comprehensive description of the device, including its intended use, technical specifications, and any claims regarding its medical purpose.

2. Risk Management:

   • Provide a Risk Management File following ISO 14971 or similar standards. This file should identify potential risks associated with the device and the mitigations implemented to reduce those risks.

3. Conformity Assessment:

   • Evidence that the device meets international regulatory standards such as:
     • CE Mark (European market approval)
     • FDA clearance or approval (U.S. market)
     • Compliance with international standards (e.g., IEC 60601 for electrical devices)

4. Quality Management System (QMS):

   • Provide evidence that your manufacturing facility complies with ISO 13485 or a similar recognized quality management system for medical devices.

5. Clinical Data:

   • Provide clinical data or performance studies demonstrating the safety and efficacy of the device (if applicable). This is especially important if the device is new or its safety and performance are not well established.

6. Labeling:

   • Labeling should include:
     • Device name, manufacturer details, intended use, instructions for use (IFU), and warnings/precautions.
     • Ensure all labeling, including the IFU, is available in Arabic and/or English as required by SFDA.

7. Manufacturing Site Information:

   • Information about the device’s manufacturing site, including proof of regulatory compliance, manufacturing processes, and quality control practices.

8. Declaration of Free Sale (if applicable):

   • A document confirming that the device is legally marketed and available for sale in the country of origin.

Step 4: Submit the Registration Application

• Online Submission:
  • SFDA uses the Medical Device Electronic System (MDES) for registration.
  • Create an account on the MDES portal (https://mdes.sfda.gov.sa).
  • Upload all the required documents through the online portal.
  • Pay the applicable registration fees based on your device category and submission requirements.
• Documents Submission:
  • Ensure that all documents are accurate, complete, and meet SFDA’s requirements before submission.
  • If submitting in Arabic and English, ensure all documents are properly translated and formatted.

Step 5: Review and Evaluation by SFDA

• Evaluation Process: After submission, the SFDA will review the registration application. This process can take a few weeks to several months, depending on the complexity of the device and completeness of the application.

• Possible Outcomes:

  • Approval: If the device meets all SFDA requirements, the registration certificate will be issued.
  • Request for Additional Information: SFDA may request further clarification or additional documents if there are any discrepancies or missing information.
  • Rejection: If the device does not meet regulatory standards, the application may be rejected, and you will be provided with reasons for rejection.

Step 6: Facility Inspection and Audit (if applicable)

• Inspection: For some devices, especially those with a higher risk or new manufacturers, SFDA may conduct an inspection of the manufacturing facility or request additional information regarding the production process and quality controls.

• Audit: If your device is subject to a more detailed review, SFDA may require an audit of the manufacturer’s QMS to verify compliance with international standards.

Step 7: Issuance of Registration Certificate

• If the SFDA is satisfied with the application and all required documents, they will issue a medical device registration certificate.

• This certificate allows the device to be marketed and sold in Saudi Arabia. The registration is valid for five years, after which the device must be re-registered.

Step 8: Post-Market Surveillance

• After registration, the manufacturer must comply with post-market surveillance requirements, including:
  • Monitoring the device’s performance in the market.
  • Reporting any adverse events or product complaints to SFDA.
  • Updating device information as necessary, including label changes or safety alerts.
• The SFDA may conduct inspections or require periodic updates to ensure continued compliance with Saudi regulations.

Step 9: Renewing Registration

• Before the expiration of the registration (typically five years), you will need to renew the registration by submitting updated documentation, as required by SFDA.

Key Considerations

• Documentation Language: Ensure that all required documentation, especially the labeling and instructions for use, are submitted in both Arabic and English.
• Device Fees: Be aware of the applicable registration and inspection fees. SFDA typically charges a fee based on the device's classification, complexity, and the number of submissions.
• Regulatory Guidance: If you are unsure about any part of the process, consider consulting with a regulatory affairs expert or a local SFDA consultant.

Conclusion

Registering a B-class medical device with SFDA involves understanding the regulatory requirements, gathering the necessary documentation, and following a systematic application process. By ensuring all documentation is accurate and complete, you can streamline the registration process and ensure compliance with Saudi regulations.

Would you like more information on any of these steps, or help with specific documentation requirements?

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