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	The application shall be submitted by an Authorized Representative of the overseas manufacturer if an overseas manufacturer wishes, after they obtain the License of authorized representative through the "GHAD System - Licensing Services": https://ghad.sfda.gov.sa/en/ Manufacture shall classify the medical device according to the “Risk Classification Rules for Medical Devices” The applicant shall submit the “Application Form for Medical Devices Marketing Authorization” electronically via “GHAD System - Marketing Authorization Services” ( https://ghad.sfda.gov.sa/en/ ) and provide the required documents specified in the application form. The applicant shall pay specified fees for the registration issued by SFDA. Once satisfied, SFDA will issue a Medical Deceive Marketing Authorization (MDMA) certificate.
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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