All medical devices are regulated by the Medical Device Sector as part of the Saudi Food & Drug Authority (SFDA).
Medical Device Definition
"Medical device" means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article (a) intended by the manufacturer to be used alone or in combination for human beings for one or more of the specific purpose(s) of diagnosis, prevention, monitoring, treatment or alleviation of disease; diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap; investigation, replacement, modification, or support of the anatomy of a physiological process; Supporting or sustaining life; Control of conception; Disinfection of medical devices; and providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body and (b) which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its intended function by such means.
Classification of Medical Device *
|Low Risk||Stethoscope, breath-alcohol test system||Class I|
|Medium Risk||Protein test systems, syringes||Class II, IIa, IIb|
|HighÂ RIsk||External/internal pacemakers, plasma warming device||Class III,IV|
- Class I: Valid for three years
- Other Classes: valid for the remaining validity period of referential country registration or three years, whichever comes sooner
* Based on Class System of Reference Country