Saudi Arabia Medical Device Registration

Saudi Arabia Medical Device Registration (SFDA – MDMA / GHTF Alignment)

1. Regulatory Authority & Legal Framework

Saudi Arabia regulates medical devices under:

• SFDA Medical Device Interim Regulation
• Medical Devices Regulatory Framework (MDRF)
• MDS–GHTF guidance documents adopted by SFDA
• MDMA – Medical Device Marketing Authorization (core certificate for market access)
• UDI system, vigilance, PMS regulations (recent updates)

Authorities involved:

• SFDA – Medical Devices Sector (MDS)
• MDMA (Marketing Authorization)
• MDNR (National Registry)
• GHTF/IMDRF recognition pathways

Saudi Arabia follows GHTF/IMDRF classification (A/B/C/D), aligned with US/EU.

2. Device Classification (Class A/B/C/D – GHTF-Aligned)

Classification principles identical to EU MDR/GHTF:
intended use, invasiveness, active nature, duration, anatomical contact, IVD risk.

3. Registration Pathway Overview

Saudi Arabia requires both establishment licensing and product registration:

3.1 Establishment Licensing (MEDL)

All companies involved in import/distribution must hold a Medical Device Establishment License (MEDL):

Types:

• Manufacturer License
• Importer License
• Distributor License

Requirements:

• QMS for distribution (often ISO 13485 / ISO 9001 accepted)
• Facility documentation
• Qualified personnel

Validity: 3 years

3.2 Product Marketing Authorization (MDMA)

This is the core registration approval required before import and sales.

MDMA includes:

• Device classification
• Technical file review
• Essential principles compliance
• Safety & performance evidence
• Clinical evaluation
• Labeling & UDI compliance

Validity: 3 years (renewable)

3.3 Listing in the National Registry (MDNR)

Once MDMA is issued, devices must be listed in the MDNR database.

4. Registration Routes (Reliance / Full Review)

Route 1 – GHTF Reliance Pathway (Fast Track)

If the device holds approval from any GHTF regulator:

• EU CE (NB/MDR/MDD)
• US FDA
• Health Canada
• PMDA Japan
• TGA Australia

Benefits:

• Significantly reduced review
• Fewer technical documents required
• Shorter evaluation times

Most international manufacturers use this pathway.

Route 2 – Full Assessment

Required when:

• No prior approval from GHTF authorities
• Novel, high-risk, or innovative technology
• Major discrepancies in intended use

Requires full:

• Technical documentation (CSDT-like)
• Safety & performance verification
• Clinical evaluation report (CER)
• Risk management (ISO 14971)

5. Dossier Requirements (SFDA CSDT / GHTF Structure)

Administrative Documents

• Application form
• Authorized Representative License (Saudi LAR)
• Free Sale Certificate / COC from country of origin
• ISO 13485 certificate
• QMS documentation
• Declaration of Conformity
• GHTF approvals (if reliance route)

Technical Documents

• Device description & intended use
• Essential Principles checklist
• Design verification & validation
• Biocompatibility
• Electrical safety & EMC (IEC 60601 series)
• Software lifecycle documentation (IEC 62304 + cybersecurity)
• Sterilization validation
• Clinical evidence or CER
• Risk management (ISO 14971)
• Labeling and IFU (Arabic OR bilingual Arabic/English)
• UDI compliance

6. Local Authorized Representative (LAR) – Mandatory

Foreign manufacturers must appoint a Saudi LAR, responsible for:

• Submission of MDMA
• Vigilance & AE reporting
• Field Safety Corrective Actions (FSCA)
• Labeling translation compliance
• Importation clearances
• Post-market surveillance

LAR controls the MDMA certificate — strategic selection is essential.

7. Fees & Timelines

7.1 SFDA Official Fees (Typical)

• MEDL (establishment license): SAR 5,000–10,000
• MDMA (product registration):
  • Class A: SAR 2,000–3,000
  • Class B: SAR 6,000–10,000
  • Class C: SAR 12,000–15,000
  • Class D: SAR 15,000–20,000

7.2 Review Timelines

• GHTF Reliance Route: ~2–4 months
• Full Review: ~6–12 months
• MEDL issuance: 1–2 months

High-risk or robotic/AI devices may undergo additional review.

8. Labeling Requirements

Saudi Arabia requires Arabic labeling (or bilingual Arabic + English) including:

• Device name, model
• Manufacturer & LAR details
• Country of origin
• UDI & barcode
• Manufacture/expiry date
• Storage/handling conditions
• Warnings and precautions
• IFU (Arabic mandatory for end-user relevant content; English can be supplemental)

Sticker labeling is acceptable.

9. Importation Requirements

After MDMA approval:

• Import under Importer MEDL license
• SFDA shipment clearance in Saber/Fasah system
• Compliance with Saudi Standards (SASO)
• UDI database entry
• Customs documentation alignment

10. Post-Market Surveillance Requirements

Mandatory elements:

• AE reporting
• FSCA notification
• Device traceability
• Complaints handling
• Recalls
• Periodic safety updates
• Product variations & renewals

11. Notes for Your Device Portfolio (Strategic Consulting View)

12. Advantages of Saudi Market (Regulatory & Commercial)

• Reliance route makes CE/FDA devices easier to register
• Largest healthcare expenditure in GCC
• Mandatory local agent ensures regulatory continuity
• Harmonized with GHTF → predictable requirements
• Strong demand for advanced technologies (robots, HF devices, imaging, monitoring)