The procedures and steps for Class C medical device registration with the Saudi Food and Drug Authority (SFDA) follow a structured process. Class C devices are considered moderate-to-high risk, requiring a more thorough review. Below is a step-by-step guide:

Step 1: Appoint a Saudi Authorized Representative (AR)

• Non-Saudi manufacturers must appoint a Saudi-based Authorized Representative (AR).
• The AR will handle all communications and submissions with the SFDA.
• The AR must have an SFDA Medical Device Establishment License (MDEL), which allows them to import and market medical devices in Saudi Arabia.

Step 2: Device Classification Confirmation

• Confirm the classification of your device as Class C according to SFDA guidelines. You can consult the SFDA’s Medical Device Classification Rule or request assistance from your AR to ensure correct classification.

Step 3: Prepare the Technical Documentation

You will need to compile comprehensive documentation for your medical device, which includes:

• Technical File (Dossier): Device description, materials, manufacturing process, intended use, risk management.
• Quality Management System (QMS): ISO 13485 certificate (or equivalent), demonstrating compliance with medical device quality management standards.
• Clinical Evaluation: Evidence of clinical safety and performance based on clinical data.
• Risk Management File: Based on ISO 14971 standards, which outlines identified risks and mitigation strategies.
• Labeling: Device labeling and instructions for use must be provided in both English and Arabic. It should follow SFDA labeling guidelines.
• Declaration of Conformity: A declaration from the manufacturer that the device conforms to relevant standards and regulations.
• Previous Certifications: Include certifications such as CE marking (EU), FDA (USA), or other international regulatory approvals, if applicable.

Step 4: Create an Account in the GHAD System

• The SFDA uses the GHAD Portal, an online platform for medical device applications.
• The AR will create an account in the GHAD system and register the manufacturer if not already registered.
• Ensure that all documentation is in electronic form and ready for upload through the system.

Step 5: Submit the Medical Device Marketing Authorization (MDMA)

• The Medical Device Marketing Authorization (MDMA) is the formal application for registering the medical device with the SFDA.
• Complete the MDMA application by uploading the technical file and other required documents in the GHAD system.
• Choose the correct classification (Class C) during the submission process.

Step 6: Pay SFDA Application Fees

• Pay the applicable registration fees to the SFDA for reviewing the submission. Fees vary based on device classification and the complexity of the application.
• The payment can be processed directly through the GHAD system.

Step 7: SFDA Technical Review

• The SFDA will conduct a technical review of your application. They will evaluate the device’s safety, clinical evidence, risk management, and compliance with Saudi regulations.
• For Class C devices, the review may take longer, and the SFDA may request additional information or clarification on the submission.
• It is common for SFDA to request clinical data or documentation proving the device’s use in other jurisdictions (e.g., CE Marking or FDA clearance).

Step 8: Address Any SFDA Requests for Additional Information

• If the SFDA requests additional documents or clarification, respond promptly through the GHAD portal to avoid delays.
• Ensure that all additional documentation meets SFDA standards and addresses their concerns fully.

Step 9: Post-Market Surveillance Plan Submission

• For Class C devices, manufacturers must submit a Post-Market Surveillance (PMS) plan. This plan should outline the procedures for monitoring the device’s performance after it enters the market and how adverse events will be handled.
• PMS may include adverse event reporting, regular safety updates, and post-market clinical follow-up (if required).

Step 10: SFDA Approval and Issuance of MDMA

• Once the review is successfully completed and the device meets all regulatory requirements, the SFDA will issue a Medical Device Marketing Authorization (MDMA) certificate.
• The device can then be legally marketed and sold in Saudi Arabia.

Step 11: Post-Market Obligations

• After the device is approved and on the market, manufacturers and ARs are required to:
  • Report adverse events related to the device to the SFDA.
  • Conduct regular reviews and updates to the PMS plan.
  • Submit renewal applications every 3 to 5 years (depending on the certificate validity) to maintain the MDMA.