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How to register and apply for Class C medical devices in Saudi Arabia?
Release time：2025-07-14 15:02:40 The author: source:
Registering and applying for Class C medical devices in Saudi Arabia involves a systematic process regulated by the Saudi Food and Drug Authority (SFDA).

Registering and applying for Class C medical devices in Saudi Arabia involves a systematic process regulated by the Saudi Food and Drug Authority (SFDA). Here’s a clear, step-by-step guide to help you navigate the registration and application:

How to Register and Apply for Class C Medical Devices in Saudi Arabia

1. Determine Device Classification

  • Confirm your device falls under Class C per SFDA classification criteria (medium to high risk).

2. Appoint a Saudi Authorized Representative (AR)

  • If you are a foreign manufacturer, you must appoint an Authorized Representative based in Saudi Arabia.

  • The AR must hold a valid Establishment License (EL) issued by SFDA.

  • Sign a formal agreement outlining responsibilities.

3. Obtain Establishment Licenses (EL)

  • Manufacturer and AR must both hold valid Establishment Licenses.

  • Apply for ELs via the SFDA GHAD portal.

  • EL approval is required prior to device registration.

4. Prepare Required Technical Documentation

  • Compile a comprehensive technical file including:

    • Device description and specifications

    • Risk management report (ISO 14971)

    • Clinical evaluation report (CER)

    • Declaration of conformity

    • ISO 13485 quality management system certificate

    • Labeling and Instructions for Use (IFU) in Arabic and English

    • Certificates of Free Sale or other regulatory approvals (e.g., CE, FDA)

5. Register on the SFDA GHAD System

6. Submit the Registration Application

  • Upload your complete application and supporting documents through GHAD.

  • Pay the applicable fees (SAR 20,000–40,000 depending on device).

7. SFDA Review Process

  • SFDA conducts technical evaluation, including documentation assessment and possible inquiries.

  • Respond promptly to any SFDA queries or requests for additional information.

8. Receive Medical Device Marketing Authorization (MDMA)

  • Upon successful review, SFDA issues the MDMA certificate valid for 3 years.

  • You can download the certificate via the GHAD portal.

9. Maintain Compliance Post-Registration

  • Implement post-market surveillance.

  • Report adverse events.

  • Renew registration before expiry.

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