Law of Medical Devices and Supplies

In this Law, the following words and phrases shall have the meanings assigned thereto, unless the context requires otherwise: Law: Law of Medical Devices and Supplies. SFDA: Saudi Food and Drug Authority. Board: SFDA’s Board of Directors. Executive Director: SFDA’s Executive Director. Regulations: Implementing Regulations of the Law. Medical Device: Any instrument, apparatus, implement, implant, in vitro reagent or calibrator, software, or material used for operating medical devices, or any other similar or related article, intended to be used alone or in combination with other devices for diagnosis, prevention, monitoring, controlling, treatment, or alleviation of disease or injury, or for compensation for an injury; investigation, replacement, modification, or support of the anatomy or of a physiological process; supporting or sustaining life; controlling or assisting conception; disinfection of medical devices; providing information for medical or personal purposes by means of in vitro examination of specimens derived from the human body; and does not achieve its primary intended action by pharmacological, immunological or metabolic means, but which may be assisted in its intended function by such means. Medical Supply: A medical material or product used in diagnosis, treatment, replacement, or bracing; or in disability cases or other medical uses for humans, including medical gases. Accessories of Medical Devices and Supplies: Any material or product intended specifically to be used with a medical device or supply to enable it to achieve its purpose. Innovative Medical Device or Supply: A medical device or supply which involves innovation in technology, use, or performance and which has not been previously introduced to the local or international market. Assembled Medical Device or Supply: Articles assembled in one kit to meet user requirements, which may contain non-medical devices or supplies. Single-use Medical Device or Supply: A disposable article intended for use on a patient in a single medical procedure. Radioactive Medical Material: A material that emits ionizing radiation either by itself or when used with other medical devices or supplies for the purpose of diagnosis and treatment. Fraudulent Medical Device or Supply: A device or supply the identity or source of which is deliberately altered with the intent to defraud. A medical device or supply shall be deemed fraudulent if its components have been