Saudi Arabia Medical Device Regulations
Regulatory Agency
Saudi Food and Drug Authority (SFDA) regulates medical devices in Saudi Arabia.
Medical Device Definition
Medical Devices: any instrument, apparatus, implement machine, implant device, in vitro reagent or calibrator, software, material, or other similar or related article intended by the manufacturer to be used, alone or in combination for diagnosis, prevention, monitoring, controlling, treatment or alleviation of disease or injuries or compensation for injuries. It is also used for investigation, replacement, modification, or support of the anatomy or of a physiological process, supporting or sustaining life (Vital functions of a human being), control of conception or assistance for that, disinfection of medical devices and supplies and providing information for medical or diagnostic purposes using in vitro examination of specimens derived from the human body. It does not achieve its primary intended action in or on the human body by pharmacological, immunological, or metabolic means, but it may be assisted in its intended function by such means.
Active Device: means any device that operates depending on a source of energy other than that generated by the human body for that purpose or by gravity and which acts by changing the density of or converting that energy. Devices intended to transmit energy, substances, or other elements between an active device and the patient without any significant change shall not be deemed to be active devices. Software shall be deemed to be an active device.
Medical Device Classification System
| Classification | Risk Level | Examples |
|---|---|---|
| Class A | Low risk | Disposable gloves, Bandages, Surgical gowns, Alcohol swabs |
| Class A Sterile | Low- medium risk | |
| Class A Measuring | ||
| Class A Reusable surgical | ||
| Class B | Low-medium risk | Blood glucose meters, Hearing aids, Electric wheelchair, Digital thermometer |
| Class C | Medium-high risk | Continuous Glucose Monitoring System (CGM), Electronic endoscopes, Implantable cardiac pacemakers, Infusion pumps |
| Class D | High risk | Artificial heart valves, Implanted nerve stimulators, Intracardiac defibrillators, and breast implants. |
Regulatory Approval Process
Classification |
Approval procedure |
|---|---|
Class A
Class B
Class C
Class D |
|
Additional Information
Approval timeline |
35 workdays. |
License validity period |
3 years |
Fees |
Class A : $3998, Class B : $5063, Class C : $5596, Class D : $6130 |
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