To register a Class D medical device in Saudi Arabia, you must apply through the Saudi Food and Drug Authority (SFDA), specifically using its designated online platforms. Below is a comprehensive guide on where and how to apply:

🏛️ Regulatory Authority

Saudi Food and Drug Authority (SFDA)
Website: https://www.sfda.gov.sa
SFDA is the national regulatory authority responsible for medical device regulation, market authorization, import control, and post-market surveillance in Saudi Arabia.

🖥️ Where to Apply: SFDA Online Platforms

🔹 1. Medical Devices National Registry (MDNR)

This is the primary portal for submitting and managing medical device registration applications, including Class D devices.

• Portal link: https://mdnr.sfda.gov.sa

• Purpose: Submit device registration, manage product licenses, upload technical documents, and track application progress.

Application Functions:

• Submit new device registration (Medical Device Marketing Authorization - MDMA)

• Renew existing approvals

• Add or update product variants

• Communicate with SFDA reviewers

🔹 2. GHAD System (Establishment Licensing Portal)

Before submitting your device application, the manufacturer and the Local Authorized Representative (LAR) must obtain an Establishment License (EL) from SFDA via the GHAD platform.

• Portal link: https://ghad.sfda.gov.sa

• Purpose: Establishment licensing and LAR registration

🔹 3. SABER (Product Import and Customs Clearance Portal)

For importing your registered Class D device into Saudi Arabia, you must also register it on the SABER platform (run by the Saudi Standards, Metrology and Quality Organization – SASO).

• Portal link: https://saber.sa

• Note: This is used after SFDA registration is approved.

📝 Summary: Where to Apply

🛠️ Account Setup Requirements

To access MDNR and GHAD:

• Saudi mobile number (for OTP verification)

• National ID/Iqama or Commercial Registration (CR) for Saudi companies

• Official appointment letter (for Local Authorized Representative)

• Email account for login and communication

🧾 Required Roles and Responsibilities

✅ Practical Tips for Using MDNR

• Use Google Chrome or Microsoft Edge for the best compatibility.

• Upload documents in PDF format, with Arabic translations where required.

• Monitor the application status regularly for queries or document requests.

• Ensure your LAR is familiar with the portal and has a valid Establishment License.

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