Handling the registration of Class D medical devices in Saudi Arabia involves a structured, step-by-step approach to meet the Saudi Food and Drug Authority (SFDA) requirements for high-risk medical devices. Here’s a practical guide on how to manage the entire process effectively:

How to Handle Class D Medical Device Registration in Saudi Arabia

1. Understand SFDA Regulations and Classification

• Thoroughly review SFDA’s Medical Device Interim Regulation and classification rules.

• Confirm that your device is correctly categorized as Class D (highest risk).

• Familiarize yourself with applicable standards and technical requirements.

2. Appoint a Local Authorized Representative (LAR)

• Foreign manufacturers must designate a Saudi-based LAR with a valid Establishment License (EL).

• The LAR will be your official contact with SFDA, responsible for submissions and communication.

3. Obtain Establishment Licenses (EL)

• Ensure both manufacturer and LAR have valid ELs via the SFDA’s GHAD portal.

• Prepare documents like commercial registration, ISO 13485 certificates, and LAR authorization letters.

• EL is a mandatory prerequisite before device registration.

4. Compile Comprehensive Technical Documentation

• Prepare a complete dossier covering:

  • Device description and specifications

  • Risk management (ISO 14971)

  • Verification & validation data (testing reports)

  • Clinical Evaluation Report (CER)

  • Labeling and bilingual Instructions for Use (IFU)

  • International approvals (CE, FDA, etc.)

• Organize files carefully following SFDA guidelines.

5. Set Up Accounts and Register on SFDA Portals

• Register both manufacturer and LAR on the:

  • GHAD portal (for EL)

  • MDNR portal (for device registration)

  • SABER platform (for customs clearance after registration)

6. Submit Application via MDNR Portal

• The LAR submits the device registration application electronically.

• Upload all required documents, pay fees, and track application status.

7. Engage During SFDA Review

• Monitor communications from SFDA through the MDNR portal.

• Respond promptly and comprehensively to any requests for additional information or clarifications.

8. Prepare for Possible On-site Audits

• SFDA may conduct inspections at manufacturing sites or LAR offices.

• Maintain up-to-date Quality Management System (ISO 13485) and technical documentation.

• Train staff to facilitate audits smoothly.

9. Receive Medical Device Marketing Authorization (MDMA)

• Once approved, download the MDMA certificate from the MDNR portal.

• Only then can you legally import, distribute, and market the device in Saudi Arabia.

10. Implement Post-Market Obligations

• Set up a Post-Market Surveillance (PMS) system.

• Report adverse events, implement Field Safety Corrective Actions (FSCA) as needed.

• Prepare for renewals and maintain valid ELs.

Tips for Smooth Registration

• Plan early: Start preparing documents and ELs well in advance.

• Hire a knowledgeable LAR: Experienced LARs can streamline communication and compliance.

• Ensure dossier quality: Complete, clear, and compliant technical files reduce review time.

• Use professional consultants: Regulatory consultants with SFDA experience can help avoid pitfalls.

• Track deadlines: Keep renewal and response timelines on your calendar.

If you want, I can provide a step-by-step checklist, templates for key documents, or advice on selecting and working with a Local Authorized Representative in Saudi Arabia.

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