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Where to apply for Class C medical device registration in Saudi Arabia?
Release time：2025-07-14 14:51:20 The author: source:
To apply for Class C medical device registration in Saudi Arabia, you must submit your application through the official online platform managed by the Saudi Food and Drug Authority (SFDA). The process involves multiple digital systems under SFDA's regulatory umbrella.

To apply for Class C medical device registration in Saudi Arabia, you must submit your application through the official online platform managed by the Saudi Food and Drug Authority (SFDA). The process involves multiple digital systems under SFDA's regulatory umbrella.

🏢 Official Regulatory Authority

🔹 Saudi Food and Drug Authority (SFDA)

🌐 Where to Apply: SFDA Online Systems

To register a Class C medical device, applications are processed through the following three main systems:

✅ 1. GHAD System (Establishment License & Registration Portal)

  • Purpose: Used for:

    • Establishment License application (manufacturer, AR, importer)

    • Medical Device Marketing Authorization (MDMA) submission

    • Uploading technical documentation and product data

  • Access:
    🔗 https://ghad.sfda.gov.sa

You must have an active user account (for both manufacturer and AR/importer) to log in and apply.

✅ 2. MDMA Application System (Inside GHAD platform)

  • Purpose: Submission of Medical Device Marketing Authorization for each Class C device.

  • What’s included:

    • Uploading technical file

    • Product identification (e.g., GMDN, UDI)

    • Declaration of conformity

    • Payment of registration fees

    • Receiving official MDMA certificate

✅ 3. DAD System (Customs Clearance Platform)

  • Purpose: After the MDMA license is granted, the DAD system is used for:

    • Product importation

    • Customs clearance approval

    • Verifying authorized importers

  • Access: Linked from the main SFDA portal

📝 What You Need Before Applying

RequirementApply inNotes
Authorized Representative (AR)Before GHAD/MDMA accessAR must be based in Saudi Arabia
Establishment License (EL)GHAD SystemRequired for AR and Manufacturer
Technical FileMDMA ApplicationMust follow SFDA/GHTF/IMDRF format
ISO 13485Upload with applicationValid and current
Labeling & IFU in ArabicUpload with applicationMandatory for registration
Free Sale Certificate (FSC)Upload with applicationFrom country of origin
Registration Fee PaymentGHAD/MDMA PortalPaid online at submission

📍 Physical Submission?

❌ No physical documents are accepted
All documentation and fees are submitted and processed electronically via the GHAD system.

🧑‍💻 Who Can Apply?

Applicant TypeWhat You Need
🇸🇦 Local Saudi company (e.g., importer)Establishment License
🌍 Foreign manufacturerMust appoint a Saudi AR to apply on their behalf
🧾 Consultants/Third-party agentsCan assist but must act via a registered AR

📌 Summary: Where to Apply

TaskSystemLink
Establishment LicenseGHADhttps://ghad.sfda.gov.sa
MDMA (device registration)GHAD → MDMA PortalSame as above
Customs clearance post-approvalDAD SystemAccess via SFDA portal

📎 Pro Tips

  • Ensure your AR and manufacturer are both registered in GHAD with active ELs.

  • Use Google Chrome for better compatibility with SFDA systems.

  • Ensure that all documents are in PDF format and follow SFDA naming guidelines.

  • Consider using a local consultant to manage Arabic translations and system navigation.

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Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn


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