To apply for Class C medical device registration in Saudi Arabia, you must follow the official process regulated by the Saudi Food and Drug Authority (SFDA). The entire application is submitted electronically through SFDA’s designated digital platform.

Here’s a step-by-step explanation of how and where to apply, including platform access, submission procedures, and account requirements.

✅ Step-by-Step: How to Apply for Class C Medical Device Registration in Saudi Arabia

🔹 Step 1: Appoint a Saudi Authorized Representative (AR)

• If you are a foreign manufacturer, you must appoint a local AR registered with SFDA.

• The AR handles:

  • Communication with SFDA

  • Document submission

  • Post-market surveillance

• A Legal Representation Agreement (LRA) is required between the AR and the manufacturer.

🔹 Step 2: Register on the GHAD System (SFDA’s Online Portal)

• Both the manufacturer and the AR must register on:
  🔗 GHAD System Portal

• Required for:

  • Applying for the Establishment License (EL)

  • Submitting Medical Device Marketing Authorization (MDMA) applications

  • Managing post-market obligations

🔹 Step 3: Obtain the Establishment License (EL)

• Apply for an Establishment License through the GHAD portal.

• Needed by both:

  • Manufacturer (foreign or local)

  • Authorized Representative (based in Saudi Arabia)

• Submit company documents:

  • ISO 13485 certificate

  • Commercial license

  • Organizational chart

  • AR agreement

• EL is mandatory before device registration.

🔹 Step 4: Prepare and Upload the MDMA Application

• Once EL is granted, proceed to Medical Device Marketing Authorization (MDMA) application.

• The MDMA is the core process for registering a device.

You must provide:

• Technical documentation (in PDF format)

• GMDN/IMDRF code

• Declaration of Conformity

• Clinical Evaluation Report

• Risk Management File

• Arabic and English IFU and labeling

• CE/FDA/TGA certificates (if applicable)

• FSC (Free Sale Certificate)

• Manufacturer–AR agreement

🔹 Step 5: Pay the Application Fee

• Fees for Class C MDMA applications typically range from:

  • SAR 8,000–15,000 (approx. USD $2,100–4,000)

• Payment is processed via the GHAD portal.

🔹 Step 6: SFDA Review Process

• The SFDA evaluates the technical file, risk classification, clinical evidence, and Arabic labeling compliance.

• Review timeline: ~3–6 months (may vary depending on file quality and response to queries)

🔹 Step 7: MDMA Certificate Issuance

• Once approved, SFDA issues the Medical Device Marketing Authorization (MDMA) certificate.

• This document allows the device to be legally marketed, distributed, and imported in Saudi Arabia.

• Valid for 3 years and renewable.

📍 Where to Submit the Application

All submissions are done online via SFDA’s GHAD platform:

🖥️ GHAD System (SFDA Portal)

• Link: https://ghad.sfda.gov.sa

• Used for:

  • Company registration

  • Establishment License application

  • MDMA device registration submission

  • Technical file uploads

  • Payment and communication

❗ No physical documents are accepted. All documents must be uploaded digitally in PDF format.

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