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Saudi Arabia Medical Device Regulations

Agency
Saudi Food and Drug Authority (SFDA) regulates medical devices in Saudi Arabia.
Medical Device Definition
A medical device in Saudi Arabia is 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. Still, it may be assisted in its intended function by such means.
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.
Approval Process
Classification Approval procedure
Class A
  • Appoint a Saudi-authorized representative (AR)
  • Identify the SFDA medical device classification.
  • Applicant shall pay fees needed
  • Apply for SFDA Registration Approval (Medical Deceive Marketing Authorization MDMA) and submit the required documentation.
  • Once satisfied, SFDA will issue the MDMA license.
Class B
Class C
Class D
Additional Information
Approval timeline 2 months Approx.
License validity period 3 years
Fees Class A :- $3998, Class B :- $5063, Class C :- $5596, Class D :- $6130
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