To register a D-class medical device with the Saudi Food and Drug Authority (SFDA), the process is outlined in a series of steps to ensure the device complies with the regulatory requirements for high-risk devices in Saudi Arabia. Below is a guide to help you through the registration process.

Steps to Register for D-Class Medical Device SFDA Registration

Step 1: Understand the Classification Criteria for D-Class Devices

Before initiating the registration process, confirm that your device qualifies as D-class according to SFDA’s classification rules. D-class devices are high-risk devices, typically those that:

• Support or sustain life.
• Are implanted into the human body.
• Pose a significant risk to the patient’s safety if not used properly (e.g., pacemakers, defibrillators, or certain types of diagnostic equipment).

You can consult the SFDA guidelines to verify the device classification.

Step 2: Appoint a Local Authorized Representative (LAR)

If your company is not based in Saudi Arabia, you must appoint a Local Authorized Representative (LAR) in Saudi Arabia. This representative will be responsible for managing the regulatory process and liaising with SFDA on your behalf.

Step 3: Prepare the Required Documentation

The registration of a D-class medical device requires thorough documentation to demonstrate the device’s safety, effectiveness, and compliance with SFDA regulations. Key documents typically required include:

1. Risk Management File: Ensure the device complies with ISO 14971 for risk management.
2. Clinical Evaluation Report (CER): This should include evidence of clinical safety and efficacy, especially for high-risk devices.
3. Conformity Assessment: Evidence that the device meets the relevant standards (e.g., ISO 13485, ISO 14971, IEC 60601 for electrical devices).
4. Performance Data and Test Reports: Include performance testing results and safety reports for the device.
5. Manufacturing Site Certification: Certification that the manufacturing facility complies with good manufacturing practices (GMP).
6. Labeling and Instructions for Use (IFU): Both in English and Arabic, the labeling should meet SFDA's guidelines.
7. Post-Market Surveillance (PMS) Plan: Outline how you will monitor the device’s safety and performance after it enters the market.
8. Market Authorization: Any existing approvals or certifications from other regulatory bodies (if applicable).

Step 4: Create an Account on SFDA's Unified Electronic System (SUES)

1. Visit SFDA's Unified Electronic System (SUES) website: Go to the official SFDA website and create a user account.
2. Complete Registration: Register as a manufacturer or authorized representative. You’ll need to provide basic company information, including contact details.

Step 5: Submit the Application through SFDA’s Medical Device Marketing Authorization (MDMA) System

1. Login to MDMA System: After registering in the SUES, log into the MDMA system, which is used to submit all medical device applications to SFDA.
2. Complete the Application Form: Fill in the required details, including:
   • Device name and classification (confirming it’s D-class).
   • Manufacturer's details (name, address, and contact information).
   • Authorized representative's details (if applicable).
   • Intended use, indications for use, and contraindications of the device.
3. Upload Required Documents: Upload all the prepared documents (risk management file, clinical reports, performance data, labeling, etc.) through the MDMA system.
4. Submit Application: After completing the form and uploading all documents, submit the application for review.

Step 6: Pay the Registration Fees

• The SFDA charges a fee for medical device registration. After submitting the application, you will be required to pay the relevant registration fees. Payment can be made through the SUES payment portal.

Step 7: SFDA Review Process

After the application is submitted, SFDA will begin its review process, which typically involves two main stages:

1. Administrative Review:
   • SFDA will check the completeness and accuracy of the submitted documents. This review typically takes 1-2 weeks.
2. Technical Evaluation:
   • SFDA will assess the device’s compliance with safety, performance, and regulatory standards. They may request further documentation or clarification during this phase. For high-risk D-class devices, the review process can take 3-6 months depending on the complexity and completeness of the submission.
   • SFDA may also request an inspection of the manufacturing facility (if the device is produced overseas) to ensure compliance with Good Manufacturing Practices (GMP).

Step 8: Respond to SFDA Queries or Requests for Additional Information

• If SFDA finds any gaps or issues in the documentation, they may request further information or clarification. It’s important to respond quickly and accurately to avoid delays in the registration process.

Step 9: Approval and Issuance of Registration Certificate

• If the review is successful and the device complies with all SFDA requirements, SFDA will approve the registration and issue a Registration Certificate for the D-class device.
• The registration certificate is typically valid for one year. After receiving the approval, the device can legally be marketed and distributed in Saudi Arabia.

Step 10: Post-Market Surveillance and Compliance

• Adverse Event Reporting: Once your device is on the market, you must have a system in place for monitoring its performance and reporting any adverse events to SFDA within 15 days of becoming aware of any issue.
• Periodic Safety Update Reports (PSUR): Submit periodic safety update reports, which might be required by SFDA to ensure continued safety and performance.
• Renewal: You will need to renew the registration annually by submitting updated documents and paying renewal fees.

Key Points to Remember:

• Timely Responses: If SFDA requests additional information, provide it promptly to avoid delays.
• Document Quality: Ensure that all documents, especially clinical and performance data, are complete and of high quality.
• Ongoing Compliance: After registration, continuously comply with post-market surveillance and reporting requirements to maintain the device’s market approval.

Summary of the Registration Process

1. Verify device classification as D-class.
2. Appoint an authorized representative (if applicable).
3. Prepare all required documents (clinical data, risk management, performance data, labeling).
4. Create an account on SFDA’s SUES system and access the MDMA system.
5. Complete the application form and submit the documentation.
6. Pay the registration fees.
7. SFDA review process (administrative and technical review).
8. Respond to queries or requests from SFDA.
9. Receive registration approval and registration certificate.
10. Monitor device performance and comply with post-market surveillance.

By following these steps, you can successfully navigate the process for registering a D-class medical device with SFDA in Saudi Arabia.