To handle Class C medical device registration in Saudi Arabia, you must comply with the regulatory requirements set by the Saudi Food and Drug Authority (SFDA). Class C devices are considered moderate-to-high risk, so the regulatory expectations are more rigorous than for lower-risk devices.

Below is a comprehensive explanation of the key requirements across legal, technical, administrative, and post-market categories:

✅ 1. Legal Requirements

🔹 1.1 Authorized Representative (AR)

• Mandatory if the manufacturer is not located in Saudi Arabia.

• The AR must be licensed by SFDA and registered in the GHAD system.

• Must sign a Legal Representation Agreement with the foreign manufacturer.

• Handles:

  • Communication with SFDA

  • Submission of applications

  • Post-market activities (recalls, incident reports)

✅ 2. Establishment Licensing Requirements

🔹 2.1 Establishment License (EL)

• Required for both:

  • The foreign manufacturer

  • The local authorized representative or importer

• The license must be obtained from SFDA through the GHAD system.

Documents Required for EL:

✅ 3. Device Classification and Conformity Assessment

🔹 3.1 Classification

• Confirm device is Class C using SFDA’s rules or IMDRF/GHTF classification framework.

• Class C includes devices such as:

  • Surgical lasers

  • X-ray imaging equipment

  • Diagnostic and therapeutic devices with moderate-to-high risk

🔹 3.2 Conformity Pathways

• If the device already has CE, FDA, or TGA approval, an abridged route may be available.

• Otherwise, a full technical documentation review is required.

✅ 4. Technical Documentation Requirements

You must prepare a Technical File that includes:

✅ 5. Medical Device Marketing Authorization (MDMA) Requirements

🔹 5.1 Application

• Submit the MDMA application through the GHAD system.

• Provide all required documentation and product identifiers.

• Pay the SFDA MDMA registration fee (~SAR 8,000–15,000).

🔹 5.2 Product Details Needed:

• GMDN Code

• UDI (if applicable)

• Product brochure

• Classification rationale

• Software version (if applicable)

✅ 6. Language and Labeling Requirements

✅ 7. Post-Market Requirements

Once the device is approved and marketed, the following are required:

🔹 7.1 Vigilance System

• You must report:

  • Serious adverse events

  • Device defects

  • Field safety corrective actions (FSCA)

🔹 7.2 Post-Market Surveillance (PMS)

• Maintain a PMS plan and submit updates when requested.

🔹 7.3 MDMA Renewal

• The MDMA certificate is usually valid for 3 years.

• You must renew before expiration by updating documentation and paying renewal fees.

✅ 8. Financial Requirements

✅ 9. Timelines

✅ In Summary: Key Requirements Checklist

Would you like a fillable checklist, a technical file template, or help connecting with registered Saudi Authorized Representatives? I can prepare those next.

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