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What documents are required for Class C medical device registration in Saudi Arabia? How to prepare the application files?
Release time：2025-07-14 14:52:23 The author: source:
To register a Class C medical device in Saudi Arabia, you must submit a complete set of documents to the Saudi Food and Drug Authority (SFDA) through the GHAD system. The documentation must demonstrate the device’s safety, performance, quality management, and regulatory compliance based on IMDRF/GHTF principles and SFDA requirements。

To register a Class C medical device in Saudi Arabia, you must submit a complete set of documents to the Saudi Food and Drug Authority (SFDA) through the GHAD system. The documentation must demonstrate the device’s safety, performance, quality management, and regulatory compliance based on IMDRF/GHTF principles and SFDA requirements.

📑 Part 1: Required Documents for Class C Medical Device Registration

The following documents are typically mandatory for the Medical Device Marketing Authorization (MDMA) application:

#DocumentDetails
1Establishment License (EL)For both the manufacturer and the Saudi Authorized Representative (AR), issued via GHAD
2Legal Representation AgreementContract between the foreign manufacturer and local AR
3Device Description & Intended UseIncludes indications, product category, variants/models
4Risk Classification JustificationBased on SFDA’s risk classification rules (confirming Class C)
5ISO 13485 CertificateQMS certification issued by an accredited body (e.g., MDSAP, CE-notified body)
6Free Sale Certificate (FSC)Issued by the regulatory authority in the country of origin
7Essential Principles ChecklistDemonstrates compliance with SFDA/GHTF safety & performance principles
8Declaration of Conformity (DoC)Signed declaration from the manufacturer confirming compliance (GHTF format)
9Clinical Evaluation Report (CER)Based on clinical data, peer-reviewed studies, or post-market evidence
10Risk Management FileIn compliance with ISO 14971: includes hazard identification, risk mitigation
11Post-Market Surveillance Plan (PMS)Describes how adverse events, complaints, and recalls will be managed
12Instructions for Use (IFU)In both Arabic and English, formatted for user clarity
13Device Labeling SamplesMust include UDI/barcode, Arabic translation, symbols, manufacturer details
14GMDN or IMDRF CodeUsed to identify the device category/class in the global nomenclature
15Product Brochure or ImagesFor SFDA reviewers to understand appearance and configuration
16Certificates of Approval (Optional but helpful)CE Certificate, FDA 510(k), TGA, Health Canada, etc. – if available
17Software Details (if applicable)For software-driven devices: include software version, cybersecurity controls, SaMD classification, etc.

🗂 All documents must be uploaded via the GHAD portal in PDF format, using SFDA’s recommended naming convention.

🗂 Part 2: How to Prepare the Application Files (Best Practices)

🔸 1. Follow IMDRF/GHTF Technical File Structure

Structure your technical documentation according to the internationally accepted format:

java复制编辑Technical Documentation Folder Structure:
├── Device Description
├── Essential Principles Checklist
├── Risk Management
├── Clinical Evaluation
├── Post-Market Surveillance Plan
├── Labeling and IFU (Arabic & English)├── Declaration of Conformity
├── QMS (ISO 13485 certificate)
├── FSC / Regulatory Approvals
├── Manufacturing Information
├── Software (if applicable)

🔸 2. Language Requirements

  • All core documentation: English

  • IFU, Labeling, and Packaging: Arabic and English (Arabic is mandatory)

  • FSC and CE/FDA certificates may be in original language (with English translation if needed)

🔸 3. Formatting and Submission Tips

  • File Format: All files must be in PDF

  • File Size: Compress if exceeding upload limits (~10–20 MB per file)

  • File Naming: Use SFDA-recommended names like:

    • IFU_Arabic.pdf

    • RiskManagement_ISO14971.pdf

    • ClinicalEvaluation_ClassC.pdf

  • Organize files in a logical and labeled folder system to avoid confusion during upload

🔸 4. Labeling Requirements

Ensure the label includes the following, in Arabic and English:

  • Product name

  • Model number

  • Lot or serial number

  • Manufacturer name and address

  • UDI/barcode

  • Manufacturing and expiry date (if applicable)

  • Storage conditions

  • Warnings, precautions, and contraindications

❗ Non-compliant labeling is one of the most common causes of SFDA application rejection or delay.

🔸 5. Clinical Evaluation for Class C Devices

For Class C, a robust CER is required. You may:

  • Provide results from clinical studies (own or third-party)

  • Use CE marking CER (if based on MEDDEV 2.7.1 Rev. 4 or MDR Annex XIV)

  • Provide literature-based justification for safety and effectiveness

  • Include real-world post-market surveillance data if applicable

📌 Optional: Templates and Tools You Can Use

If you’re preparing files from scratch, the following templates are highly useful:

  • ✅ Declaration of Conformity (DoC) – per GHTF/SG1/N78

  • ✅ Risk Management File – ISO 14971-compliant

  • ✅ Clinical Evaluation Report template

  • ✅ Essential Principles Checklist (SFDA version)

  • ✅ Labeling sample with Arabic translation

Let me know if you’d like editable versions of any of these.

📎 Summary Table: Core Documents Checklist

✔DocumentArabic Required?Mandatory?
✅ISO 13485 CertificateNoYes
✅Free Sale CertificateNoYes
✅Device DescriptionNoYes
✅IFUYesYes
✅LabelingYesYes
✅Clinical Evaluation ReportNoYes
✅Risk Management FileNoYes
✅Post-Market Surveillance PlanNoYes
✅Declaration of ConformityNoYes
✅GMDN CodeNoYes

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