For Class C medical device registration in Saudi Arabia, the technical documentation is a crucial part of the application, as it demonstrates your device’s compliance with safety, performance, and regulatory standards according to SFDA and international guidelines (IMDRF/GHTF).

📋 Key Requirements for Technical Documentation (Class C Devices)

The technical file should be comprehensive, organized, and must cover the following elements:

1. Device Description and Specification

• Detailed product description including model/version numbers.

• Intended purpose, clinical indications, target patient/user group.

• Physical and functional characteristics.

• Accessories and variants.

• Device classification justification (why it is Class C).

2. Essential Principles Checklist

• A checklist demonstrating compliance with SFDA’s Essential Principles of Safety and Performance (similar to GHTF guidelines).

• Mapping of each essential principle to supporting evidence in the technical file.

3. Risk Management File

• A complete risk management report following ISO 14971.

• Identification of hazards, risk analysis, evaluation, control measures, and residual risk.

• Risk-benefit analysis and justification.

4. Clinical Evaluation Report (CER)

• Clinical evidence supporting device safety and performance.

• Summary of clinical studies, literature reviews, or equivalence data.

• Analysis of clinical risks and benefits.

• Post-market clinical follow-up data if available.

• CER must comply with MEDDEV 2.7.1 Rev 4 or relevant SFDA guidance.

5. Declaration of Conformity

• Formal declaration by the manufacturer that the device complies with all applicable regulations and standards.

• Must be signed and dated.

• Should reference applicable standards and directives.

6. Quality Management System (QMS) Evidence

• Copy of valid ISO 13485 certification issued by an accredited certification body.

• Evidence that the manufacturer’s QMS covers the device scope.

7. Labeling and Instructions for Use (IFU)

• Draft labeling and packaging artwork samples.

• IFU in both Arabic and English, clear and user-friendly.

• Labels must include product name, model, manufacturer info, lot number, expiry, warnings, and storage instructions.

• Inclusion of UDI (Unique Device Identification) if applicable.

8. Manufacturing Information

• Overview of manufacturing process, site location.

• Information on sterilization (if applicable).

• Packaging and shipping conditions.

9. Certificates of Regulatory Approvals

• Free Sale Certificate (FSC) from country of origin or current market authorization.

• Copies of CE Mark, FDA 510(k), TGA, or other international certifications if available.

10. Post-Market Surveillance (PMS) Plan

• Procedures for ongoing monitoring of device safety and effectiveness.

• Complaint handling, adverse event reporting, and recall procedures.

11. Software Documentation (If applicable)

• Software lifecycle documentation.

• Cybersecurity risk assessment.

• Software validation and verification reports.

🗂 How to Organize Your Technical Documentation

SFDA recommends structuring the technical file similar to IMDRF/GHTF Technical File Guidelines:

java复制编辑Technical File Structure:
├── 1. Device Description
├── 2. Essential Principles Compliance
├── 3. Risk Management Report
├── 4. Clinical Evaluation Report
├── 5. Declaration of Conformity
├── 6. Quality Management System Certificate
├── 7. Labeling and IFU (Arabic & English)├── 8. Manufacturing Information
├── 9. Regulatory Approvals (FSC, CE, FDA etc.)├── 10. Post-Market Surveillance Plan
├── 11. Software (if applicable)

📌 Important Tips

• Ensure Arabic translations are accurate and clear for IFU and labeling.

• Use PDF format for all documents.

• Cross-reference each section to support claims made in the risk management and clinical evaluation.

• Maintain traceability throughout the file for easy review.

• Submit via the SFDA’s GHAD system for online registration.

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