1. Certification Overview
The SFDA defines medical devices as follows.
“Medical device” refers to any machine, tool, application device, implantable device, laboratory reagent, laboratory measurement substance, medical device operating program or material, or similar or related device manufactured alone or in combination with other devices that satisfies one or more of the following: – Diagnosis, prevention, monitoring, treatment, or alleviation of disease; – Diagnosis, monitoring, treatment, alleviation, or compensation for injury or disability; – Investigation, replacement, modification, or support of anatomical or physiological processes; – Support or maintenance of life; – Control of conception; – Disinfection of medical devices; – Acts of providing information for medical or diagnostic purposes through in vitro examination of specimens taken from the human body.
SFDA medical device certification requires an Authorized Representative (AR) in Saudi Arabia.
The SFDA classifies medical devices into four levels, from Class A to D, based on their risk level.
2. Regulatory Bodies & Basic Information
| Regulatory Agencies | SFDA (Saudi Food and Drug Authority) |
| Certification (Registration) Authority | SFDA (Saudi Food and Drug Authority) |
| Lead time / Price | Varies by product |
| Agent | Local agent required |
3. Medical Device Classification
| Class | Risk | Example | |
|---|---|---|---|
| Class A | Low risk | • Manual Surgical & Diagnostic Instruments: Surgical forceps & scalpel handles, Mechanical stethoscopes, Tongue depressors • General Assistive Furniture & Equipment: Manual wheelchairs, Examination tables • Basic Consumables : Non-sterile bandages, Examination gloves |  Tongue depressors |
| Class B | Low to Moderate risk | • Electronic Diagnostic & Monitoring Devices: Digital thermometers, Electronic sphygmomanometers, Hearing aids • Sterile Consumables & Surgical Wear: Sterile surgical gloves, Disposable syringes with needles, Infusion sets • [가정용 뷰티 기술군] Energy-based Home-use Devices: Low-power LED masks, Microcurrent skin massagers |  Low-power LED masks |
| Class C | Moderate to High risk | • Active Therapeutic & Diagnostic Systems: Diagnostic X-ray apparatus, Ultrasound imaging systems, Magnetic Resonance Imaging/MRI • Professional Aesthetic & Surgical Equipment: Clinical High-intensity focused ultrasound/HIFU, RF electro-surgical units, Medical surgical lasers • Invasive Materials & Disposables: Contact lenses, Blood bags |  Contact lenses |
| Class D | High risk | • Life-Sustaining & Central Circulatory Implants: Implantable pacemakers, Coronary/Vascular stents, Artificial heart valves • Advanced Life-Support Systems: Mechanical ventilators, Defibrillators, Anesthesia workstations • Injectable Materials & Permanent Implants: Hyaluronic acid dermal fillers, Absorbable surgical sutures, Artificial hip joints |  Anesthesia workstations |
4. Certification Process
- Appointment of Saudi Certified Representative (AR)
- Preparation of technical documentation for MDMA submission
- MDMA Submission (GHAD Portal-Eservice)
- Fee payment
- Supplementation and Response
- MDMA approval
- Issuance of Market Authorization Certificate and Registration of Product UDI Information
5. Required Documents
| Administrative & Legal Documents | • Authorized Representative Agreement (AR Agreement) • MDMA Application Form via GHAD System • Evidence of Approval in Other Countries (Optional) • Payment Receipt |
| Quality Management System Documents | • Quality Management System Certification (QMS / ISO 13485 Certification) • Certificate from a Saudi Conformity Assessment Body (CAB) or Factory Inspection Report |
| Technical & Safety Dossier / TFA | • Device Description & Manufacturing Information • Essential Principles Checklist & DoC • Risk Management File • Product Verification & Validation / Clinical Data • Post-Marketing Surveillance Plan & PSUR • Saudi Target Labeling & Instructions for Use |
6. Validity Period and Maintenance
- Validity Period: 3 years
- Renewal: Submit renewal application 2 months before expiration
- Material change: Report within 10 days of the change (SFDA approval required)
- Minor changes: Notify within 30 days of the change (SFDA approval not required)
Source
Laws and Regulations