Registering Class D medical devices in Saudi Arabia involves meeting strict requirements set by the Saudi Food and Drug Authority (SFDA). These devices represent the highest risk class and thus are subject to comprehensive technical, clinical, quality, and administrative requirements.

Below is a detailed overview of the requirements for registering Class D medical devices in Saudi Arabia:

🔹 1. Establishment Licensing (EL)

Before registering a device, both the manufacturer and the Local Authorized Representative (LAR) must obtain an Establishment License from SFDA.

Requirements:

• Valid commercial registration

• Quality Management System certificate (e.g., ISO 13485)

• Signed agreement between manufacturer and LAR

• Facility and operational compliance with SFDA standards

🔹 2. Appoint a Local Authorized Representative (LAR)

Foreign manufacturers must appoint a Saudi-based Local Authorized Representative.

LAR Responsibilities:

• Act as the legal liaison with SFDA

• Submit all applications and documentation

• Maintain vigilance and post-market surveillance records

• Support adverse event reporting and product recalls

🔸 The LAR must also be registered with the SFDA and hold an Establishment License.

🔹 3. Device Classification Confirmation

The device must be confirmed as Class D under the SFDA’s risk-based classification rules.

• Use the SFDA “Guidance on Classification Rules for Medical Devices” document.

• Provide justification for classification, especially for borderline cases.

🔹 4. Technical Documentation (Design Dossier)

Comprehensive technical documentation is mandatory for Class D devices. It should follow GHTF/IMDRF or EU MDR formatting.

Must include:

• General description of the device and its variants

• Device specifications and materials

• Design verification and validation data

• Risk analysis and risk management report (per ISO 14971)

• Biological evaluation (ISO 10993 series)

• Sterilization validation (if sterile)

• Software validation (if applicable)

• Electrical safety and EMC testing (IEC 60601, etc.)

• Performance testing data (bench, pre-clinical, etc.)

🔹 5. Clinical Evaluation

Clinical data is mandatory for Class D devices.

Required documentation:

• Clinical evaluation report (CER) per MEDDEV 2.7/1 rev. 4 or equivalent

• Clinical investigation results (if applicable)

• Post-market clinical follow-up plan

• Literature review and equivalence justification

If a device is new or lacks predicate devices, clinical trials may be required.

🔹 6. Quality Management System (QMS)

Manufacturers must hold a valid ISO 13485:2016 certificate issued by an SFDA-recognized Notified Body.

Additional QMS documents required:

• Management review records

• Internal audit results

• Complaint handling procedures

• Product traceability and recall plans

🔹 7. Labeling and Instructions for Use (IFU)

Labeling must comply with SFDA's labeling requirements.

Key points:

• Arabic and English language

• Include product name, intended use, manufacturer info, batch/lot number, expiry date

• IFU must clearly describe usage, warnings, precautions, and disposal

• UDI (Unique Device Identifier) if applicable

🔹 8. Conformity Assessment Evidence

• CE certificate (under MDR or MDD), FDA 510(k)/PMA approval, or other foreign approval certificates.

• Certificate of Free Sale or marketing authorization from the country of origin.

• Declaration of Conformity (DoC) from the manufacturer.

🔹 9. Submission through MDNR Portal

All applications must be submitted via the SFDA Medical Devices National Registry (MDNR) platform.

Website: https://mdnr.sfda.gov.sa

Required:

• Online application form

• All documents in PDF (English or Arabic)

• Pay the applicable Class D registration fee

🔹 10. Importer Registration

If the product will be imported, the importer must also be licensed by SFDA and registered in the SABER platform (used for product clearance at Saudi customs).

🔹 11. Post-Market Surveillance (PMS) Plan

Include a plan for:

• Adverse event reporting

• Vigilance

• Field safety corrective actions (FSCA)

• Periodic safety update reports (PSUR) if applicable

🔹 12. Product Testing (if required)

• SFDA may require additional batch testing, type testing, or lab analysis, especially for implantable or sterile devices.

• Reports must be from accredited labs (ISO 17025).

📌 Summary Table of Key Requirements

🕒 Timeframe & Fees

• Timeframe: 6 to 12 months for Class D devices

• SFDA Fees: Varies; for Class D devices, usually SAR 20,000–40,000+ depending on complexity

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