Registering Class D medical devices in Saudi Arabia is a detailed and regulated process governed by the Saudi Food and Drug Authority (SFDA). Class D represents the highest-risk category of medical devices, such as implantable, life-supporting, or invasive products. The registration process is rigorous and involves multiple steps, specific documents, and careful compliance with national regulations.

🔷 1. Registration Process for Class D Medical Devices in Saudi Arabia

✅ Step-by-Step Process:

Step 1: Confirm Device Classification

• Use SFDA’s classification rules based on IMDRF/GHTF principles.

• Class D includes devices with the highest risk: e.g., pacemakers, orthopedic implants, dialysis machines, ventilators.

Step 2: Appoint a Local Authorized Representative (LAR)

• Foreign manufacturers must appoint a Saudi-based LAR.

• The LAR acts as the legal contact with SFDA and submits applications.

• LAR must obtain an Establishment License (EL).

Step 3: Obtain Establishment License via GHAD Portal

• Apply through the GHAD system: https://ghad.sfda.gov.sa

• The LAR and manufacturer must be registered.

• The EL is mandatory before registering any devices.

Step 4: Prepare Technical Documentation

• Build a complete technical file (design dossier) per SFDA guidelines.

• This includes safety, performance, risk management, and clinical data.

Step 5: Submit Device Registration via MDNR

• Portal: https://mdnr.sfda.gov.sa

• Upload documents and complete the online registration form.

• Pay registration fees and submit for SFDA review.

Step 6: SFDA Review and Approval

• SFDA conducts a comprehensive review, including:

  • Technical & safety assessment

  • Clinical evidence verification

  • Labeling and IFU compliance

  • Potential QMS audits for high-risk devices

• Duration: 6–12 months, depending on completeness and complexity

Step 7: Receive Marketing Authorization (MDMA Certificate)

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

• Required for product import and commercial distribution.

Step 8: Post-Market Surveillance Compliance

• Implement vigilance and adverse event reporting.

• Maintain product traceability and field safety corrective actions (FSCA).

• Renew MDMA as required (usually valid for 3–5 years).

📄 2. Required Documents for Class D Registration

📁 Technical Documentation:

• Device description and specifications

• Design dossier (full technical file)

• Risk Management Report (ISO 14971)

• Clinical Evaluation Report (CER)

• Biocompatibility, sterilization, software validation (if applicable)

• Performance and safety test reports (e.g., IEC 60601, ISO 10993, etc.)

📑 Quality and Regulatory Documents:

• ISO 13485 certificate (valid and issued by SFDA-recognized body)

• Declaration of Conformity (DoC)

• CE Certificate or other approval (e.g., FDA 510(k), TGA, etc.)

• Certificate of Free Sale (from country of origin)

• Market history or proof of commercialization in other countries

🏷️ Labeling & IFU:

• Product labels (Arabic and English)

• Instructions for Use (Arabic and English)

• UDI (if applicable)

📜 Administrative Documents:

• LAR appointment letter

• Commercial registration (CR) certificate of the LAR

• Establishment License (EL) from GHAD

• Application form and fee payment receipt

⚠️ 3. Important Considerations for Class D Devices

🔸 High Scrutiny by SFDA

• Class D devices undergo in-depth technical and clinical review.

• In some cases, SFDA may require:

  • Product-specific testing

  • Site audits

  • Batch release inspections (especially for sterile/implantable products)

🔸 Clinical Evaluation is Mandatory

• Clinical Evaluation Report (CER) must follow recognized guidelines.

• New or high-risk technologies may require local clinical trials or additional data.

🔸 Labeling Must Be Compliant

• SFDA mandates bilingual labeling (Arabic + English).

• Noncompliant labeling is a common cause of delay.

🔸 Post-Market Responsibilities

• The LAR must report serious incidents and maintain vigilance files.

• Maintain PMS procedures in accordance with SFDA guidelines.

🔸 Cost and Time

📌 Summary Table

Would you like templates for the CER, DoC, or a checklist to guide your Class D registration project? I can also assist in identifying qualified LARs or regulatory consultants in Saudi Arabia.

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