The medical device sector is mainly in charge of registration, implementation and regulation of all medical devices either locally produced or imported to the kingdom of Saudi Arabian market through the following departments: Pre-marketing Department: This department is in charge of classifying, evaluating, registering and "licensing or certifying" all medical devices and establishments which produce and/or sell medical devices in Saudi Arabia , including "electrical devises" that are suspected to have adverse effect on human health . It will also insure that manufacturers are applying the Good Manufacturing Practice. Post-market Department: This Department is in charge of following up medical devices placed in market after certification at the site of functioning and making sure the continuity of its safety performance throughout feedback reports for any incidence or problem could appear their..

Any instrument, apparatus, appliance, material or other, article, whether used alone or in combination, together with any accessories including the software necessary for its proper application and functioning, intended by the manufacturer to be used for human beings for the purpose of :- Diagnosis, prevention, monitoring, treatment or alleviation of disease- Diagnosis, monitoring, treatment or alleviation of compensation for any injury or handicap- Investigation, replacement or modification of the anatomy or of a physiological process- Control of conception. AS Active medical device- -Active implantable medical device -Custom-made device -Device intended for clinical investigation -Device for self-testing And which dose not achieve its principal intended action in or on the human body by:- -Pharmacological -Immunological -etabolic means. But which may be assisted in its function by such means.

Due to the lack of standards that assure Safety and Quality of the medical devices in Saudi Arabia, the SFDA will apply set up all standards that assure the safety of performance of these devices as approved internationally.

Medical devices sector will set up all regulation and requirements required for registering both the establishments (Manufacturer, importers, and distributor) and the medical devices and make sure that the device are complying with those requirements, before it allowed to be placed in the Saudi market.

Communication with hospitals and healthcare facilities in the Kingdom is one of the Sector's activities to receive the technical problem and adverse events reports on medical devices, evaluate them and take the appropriate action. The center also aims cooperating with other international problems reporting centers to exchange reports on medical devices.