For Class D medical device registration in Saudi Arabia, the Saudi Food and Drug Authority (SFDA) requires comprehensive technical documentation (also called the design dossier) that demonstrates the device’s safety, performance, and compliance with regulatory standards. This documentation is the core evidence SFDA evaluates before granting marketing authorization.

📑 Key Technical Documentation Requirements for Class D Devices

1. Device Description and Specifications

• Detailed description of the device, model numbers, variants, accessories.

• Intended use and indications.

• Technology and principles of operation.

• Materials used, including patient-contact materials.

• Description of sterilization status and packaging.

2. Essential Principles Checklist

• A table or report demonstrating conformity with SFDA’s Essential Principles of Safety and Performance for medical devices.

• Reference to relevant standards (e.g., ISO 14971, IEC 60601 series).

3. Risk Management File

• Comprehensive risk analysis per ISO 14971.

• Identification of hazards, risk estimation, evaluation, and control measures.

• Residual risk assessment and risk-benefit analysis.

• Evidence of risk monitoring during post-market.

4. Design and Manufacturing Information

• Design drawings, diagrams, or flowcharts.

• Description of manufacturing processes.

• Details on suppliers of critical components.

• Quality controls applied during manufacturing.

5. Verification and Validation Data

• Bench testing, functional testing results.

• Electrical safety and electromagnetic compatibility (EMC) test reports, typically IEC 60601 series for electrical devices.

• Software validation and verification documentation, if applicable (IEC 62304).

• Mechanical and physical testing results.

6. Biocompatibility Evaluation

• Reports following ISO 10993 standards relevant to patient-contact materials.

• Cytotoxicity, sensitization, irritation, systemic toxicity, or other tests as applicable.

7. Sterilization and Shelf-life Data

• Validation of sterilization processes (ISO 11135, ISO 11137, etc.).

• Packaging validation ensuring sterility maintenance.

• Shelf-life and stability studies, if applicable.

8. Clinical Evaluation Report (CER)

• Summary and critical appraisal of clinical data supporting device safety and performance.

• Includes literature review, clinical investigations, equivalence justification.

• Must meet SFDA clinical evaluation requirements and guidelines.

9. Labeling and Instructions for Use (IFU)

• Copies of all labels and packaging artwork.

• IFU in Arabic and English, compliant with SFDA guidelines.

• Inclusion of warnings, contraindications, precautions, and symbol explanations.

10. Previous Regulatory Approvals

• Copies of CE certificates, FDA clearances (510(k), PMA), or other recognized approvals.

• Declaration of Conformity (DoC).

• Certificate of Free Sale from the country of origin.

11. Additional Documentation (If Applicable)

• Unique Device Identification (UDI) information.

• Post-market surveillance plan.

• Software lifecycle documentation for software as a medical device.

• Any applicable certificates for Good Manufacturing Practice (GMP) or site audits.

📌 Summary Table

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