To apply for Class D medical device registration in Saudi Arabia, manufacturers and their appointed representatives must meet specific regulatory, technical, quality, and administrative conditions set by the Saudi Food and Drug Authority (SFDA). These conditions ensure that high-risk (Class D) devices—such as implants, life-support systems, and invasive devices—are safe, effective, and compliant with local laws.

Here is a detailed breakdown of the key conditions that must be met before applying for Class D medical device registration in Saudi Arabia:

✅ 1. Correct Device Classification (Class D)

• You must classify the device according to SFDA’s classification rules, which are aligned with IMDRF/GHTF frameworks.

• Class D typically includes:

  • Implantable devices (e.g. orthopedic, cardiovascular)

  • Life-supporting equipment (e.g. ventilators, pacemakers)

  • Critical diagnostic devices (e.g. IVDs for HIV, blood grouping)

• Provide classification rationale using SFDA's risk-based criteria.

✅ 2. Appoint a Local Authorized Representative (LAR)

• Foreign manufacturers are required to appoint a Saudi-based LAR.

• The LAR must be:

  • A legally registered Saudi company

  • Licensed by SFDA

  • Holding a valid Establishment License (EL)

• The LAR is responsible for:

  • Submitting applications

  • Communicating with SFDA

  • Handling post-market surveillance

✅ 3. Obtain Establishment License (EL)

Before applying for product registration, both the manufacturer and the LAR must obtain an Establishment License via SFDA’s GHAD platform.

Requirements include:

• Valid Commercial Registration (CR)

• ISO 13485 certificate (for manufacturer)

• Signed LAR agreement or appointment letter

• QMS documentation (if requested)

📌 GHAD Portal: https://ghad.sfda.gov.sa

✅ 4. Quality Management System (QMS) Compliance

• The manufacturer must have a valid ISO 13485:2016 certificate issued by an SFDA-recognized certification body.

• Certificate must:

  • Cover the relevant manufacturing site(s)

  • Be valid on the date of application

  • Include the scope that covers the device in question

✅ 5. Technical Documentation Prepared

You must prepare and submit a complete technical dossier, which includes:

• General product description

• Design verification and validation

• Risk management report (ISO 14971)

• Clinical Evaluation Report (CER)

• Biocompatibility, sterilization, and software validation (if applicable)

• Product labels and Instructions for Use (IFU) in Arabic and English

✅ 6. Regulatory Approvals or Conformity Evidence

You must demonstrate that the device has been legally marketed or approved in other recognized markets:

Acceptable evidence includes:

• CE certificate under EU MDR (preferred)

• FDA 510(k) or PMA approval

• Certificate of Free Sale (CFS) from country of origin

• Declaration of Conformity (DoC) signed by manufacturer

• Market history of the device

Devices without existing approvals may be subject to enhanced clinical scrutiny or local trials.

✅ 7. Bilingual Labeling Compliance

All packaging, labels, and Instructions for Use (IFU) must be provided in both Arabic and English and comply with SFDA requirements, including:

• Product name and model

• Manufacturer and LAR information

• Expiry date, batch/lot number

• Storage conditions

• Warnings and symbols

✅ 8. Clinical Evaluation Must Be Available

• A full Clinical Evaluation Report (CER) is mandatory for Class D devices.

• CER should be based on:

  • Literature review

  • Clinical investigation results (if applicable)

  • Post-market clinical follow-up (PMCF) data

• SFDA may request additional clinical data or trials, especially for new or novel devices.

✅ 9. SFDA Online Portals Access

• The applicant must have valid access to:

  • MDNR for device registration: https://mdnr.sfda.gov.sa

  • GHAD for Establishment Licensing: https://ghad.sfda.gov.sa

• The account must be linked to the LAR's licensed company.

✅ 10. Post-Market Surveillance (PMS) Preparedness

SFDA requires a plan for vigilance and post-market monitoring. Before registration:

• Prepare a PMS plan

• Be ready to report adverse events, recalls, or Field Safety Corrective Actions (FSCA)

• Maintain traceability and complaint handling procedures

✅ 11. Payment of SFDA Fees

Applicable fees for Class D registration must be paid before the application is reviewed:

🔍 Summary: Key Conditions Checklist

📌 Next Steps

1. Confirm device classification under SFDA guidelines

2. Appoint an LAR and register them on GHAD

3. Obtain Establishment License for manufacturer and LAR

4. Prepare a compliant dossier

5. Submit via MDNR portal

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