Saudi Arabia Medical Device Regulations

Agency
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 *
Risk ClassificationExamplesClass
Low RiskStethoscope, breath-alcohol test systemClass I
Medium RiskProtein test systems, syringesClass II, IIa, IIb
High RIskExternal/internal pacemakers, plasma warming deviceClass III,IV
Premarket Approval Process
Low RiskMedium RiskHigh Risk
Before selling in Saudi Arabia, device must be authorized in reference country (Australia, Canada, Europe, Japan, or USA)
Appoint representative in Saudi Arabia. Representative must fill out an Authorized Representative (AR) contract, which will be reviewed by the SFDA.
Submit Medical Device Marketing Authorization (MDMA) application through AR. This application will include: device labeling, IFU, and promotional materials in both English and Arabic. It also needs to include documentation of approval in reference markets and certification in English. For application fees and Review times click here
SFDA reviews application and then Conformity Assessment Body (COB) performs a rigorous technical review of application. Often times applications go through multiple rounds of this and questioning.
CAB will make recommendation to SFDA who will make the final decision. If approved SFDA will issue an MDMA certificate.
Post Market
Validity
  • 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

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