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Registering Class D medical devices in Saudi Arabia involves preparing a comprehensive set of technical, regulatory, and administrative documents in line with the requirements of the Saudi Food and Drug Authority (SFDA). Since Class D devices are high-risk, SFDA requires a full design dossier (technical documentation), quality system evidence, and detailed clinical evaluation.
Below is a detailed guide on the required documents and how to prepare the application files for submission through the SFDA’s Medical Devices National Registry (MDNR) portal.
✅ PART 1: Required Documents for Class D Medical Device Registration
The documents are grouped into four major categories
:
📁 A. Technical Documentation (Design Dossier)
These documents must demonstrate the safety, performance, risk management, and design of the device:
| Document | Description |
|---|---|
| 1. Device Description | Overview of the device, model/variants, intended use, and technology |
| 2. Essential Principles Checklist | Compliance with SFDA’s safety & performance requirements |
| 3. Risk Management Report | Per ISO 14971: Identify hazards, mitigation, residual risks |
| 4. Product Verification & Validation | Bench testing, electrical safety (e.g., IEC 60601), performance studies |
| 5. Software Validation Report (if applicable) | For software-based or software-controlled devices (IEC 62304) |
| 6. Biocompatibility Report | Based on ISO 10993 standards for patient-contacting materials |
| 7. Sterilization Validation Report | If sterile, include validation per ISO 11135/11137 or equivalent |
| 8. Stability or Shelf-life Studies | Especially for IVDs or consumables |
| 9. Clinical Evaluation Report (CER) | Detailed review of clinical data, trials, and equivalence |
| 10. Summary Technical Document (STED) or Design Dossier | Optional STED format based on GHTF guidelines is acceptable |
📑 B. Quality Management System (QMS) Documents
SFDA requires evidence of the manufacturer’s compliance with quality standards:
| Document | Description |
|---|---|
| 1. ISO 13485 Certificate | Issued by an SFDA-recognized notified body (must be valid) |
| 2. QMS Scope Document | Indicates that the manufacturing site is certified for the registered product |
| 3. Internal Audit & Management Review Records | Required if SFDA performs a site audit |
| 4. Complaint Handling Procedure | Evidence of post-market quality system practices |
| 5. Product Recall and FSCA Procedures | Describe mechanisms for field safety actions |
📜 C. Regulatory and Market Authorization Documents
These confirm the device is legally marketed in other jurisdictions:
| Document | Description |
|---|---|
| 1. CE Certificate / FDA 510(k) / PMDA / TGA Approval | From at least one recognized jurisdiction |
| 2. Declaration of Conformity (DoC) | Signed by the manufacturer, listing standards and regulations met |
| 3. Certificate of Free Sale (CFS) | Issued by the competent authority in the country of origin |
| 4. Market History Report | List of countries where the device is legally marketed |
| 5. Previous Regulatory Decisions | Any prior rejections, withdrawals, or adverse actions, if applicable |
🏷️ D. Labeling and Arabic-Translated Documentation
All Class D device documentation must include bilingual (Arabic + English) materials.
| Document | Description |
|---|---|
| 1. Device Label Samples | Packaging, unit label, overpack label, shipping labels |
| 2. Instructions for Use (IFU) | In both English and Arabic, compliant with SFDA format |
| 3. UDI Information (if applicable) | Unique Device Identifier details, barcodes, GS1/HIBC, etc. |
✅ PART 2: How to Prepare the Application Files for SFDA Submission
📦 File Format and Organization
Format: PDF only
File Naming: Use clear, standardized names (e.g.,
Risk_Management_Report_ModelXYZ.pdf)Language: Documents must be in English, with Arabic translations for labeling and IFU
File Size: Max 10MB per file on MDNR; compress large files as needed
Folder Structure: Organize into logical sections — Technical, QMS, Regulatory, Labeling
📂 Suggested Folder Structure
swift复制编辑/Registration_Application_ClassD/│├── Technical_Documentation/│ ├── Device_Description.pdf│ ├── Risk_Management_Report.pdf│ ├── Biocompatibility_Testing.pdf│ └── Clinical_Evaluation_Report.pdf│├── QMS_Certification/│ ├── ISO13485_Certificate.pdf│ ├── Internal_Audit_Summary.pdf│ └── Complaint_Handling_Procedure.pdf│├── Market_Authorization/│ ├── CE_Certificate.pdf│ ├── Certificate_of_Free_Sale.pdf│ └── DoC_Declaration.pdf│├── Labeling/│ ├── Label_Samples_English.pdf│ ├── Label_Samples_Arabic.pdf│ └── IFU_Bilingual.pdf
🔐 SFDA Online Portal: MDNR Submission
Access MDNR: https://mdnr.sfda.gov.sa
Register account for your company or LAR
Fill in product details (name, classification, GMDN code, UDI)
Upload all required documents
Pay the applicable Class D registration fee
Track application status and respond to queries from SFDA reviewers
⚠️ Important Considerations
| Area | Tip |
|---|---|
| Completeness | Incomplete documentation is a leading cause of rejection. Use SFDA’s checklist. |
| Clinical Evidence | Class D devices must have robust clinical support — weak CERs delay approval. |
| Arabic Translation | Required for all labels, IFU, and critical patient-facing materials. |
| Label Compliance | Include symbols, manufacturing/expiry dates, model number, manufacturer name & address. |
| Response Time | Respond quickly to SFDA questions or requests to avoid application expiration. |
📌 Summary: Key Documents Checklist
| Category | Required Documents |
|---|---|
| Technical | Device Description, Risk Management, Bench/Performance Testing, Clinical Evaluation, Biocompatibility |
| QMS | ISO 13485 Certificate, Complaint Handling SOP, Recall Procedure |
| Regulatory | CE/FDA Certificate, DoC, Certificate of Free Sale, Market History |
| Labeling | Arabic + English IFU, Device Labels, UDI (if applicable) |
Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn
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Whatsapp or Wechat：+86 15816864648
Email address：hito.lin@grzan.cn
Add: Room 103-108, Building B, Block 2, Bangkai Science and Industrial Park, NO.9, Guangyuan 5th Road, Fenghuang Street, Guangming District, Shenzhen City, Guangdong Province, China.
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