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To be eligible to export to KSA, the aim of controlling the entire food chain from the country of origin to Saudi Arabia in coordination with the competent authorities in the exporting countries based on the approved mechanisms where the factories are approved and published on the SFDA’s website.
by submit the request through SFDA administration communcation system to Establishment License Department in Operation Sector
The manufacturer is responsible for monitoring its medical devices, and informing users about any instructions for the safety or quality of the medical device. If there is any problem related to supplying or using the device, the manufacturer should inform the SFDA directly.
Kindly check the link below: https://www.sfda.gov.sa/en/regulations/69500
To verify the procedures carried out by the competent control authority responsible for food safety in the countries interested in exporting food products to KSA. This step paves the way for assigning the competent authority the responsibility of approving the establishments interested in exporting food products to the Saudi market, Or for the SFDA’s approval for the establishments interested to export to the Kingdom.
An organization managing a database of information on safety and/or
performance related aspects of medical devices and employing staff
capable of taking appropriate action on any confirmed problems.
Standards document contains many importants parts such as scope, normative references, terms and definitions, general requierments, marking, labelling and packaging and many more depend on the standard subject.
An electronic system launched to facilitate the importing, transporting and exporting of medical radioactive materials registering requests. Furthermore, it contributes to the coordination between all relevant parties to ensure the arrival of those materials to the beneficiary in accordance with the authorized activity and quantity, you can login to the system through:
https://mrmr.sfda.gov.sa
means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar that 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,
o Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
o Investigation, replacement, modification, or support of the anatomy or of a physiological process,
o Supporting or sustaining life,
o Control of conception,
o Disinfection of medical devices,
o Providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body
and any device 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.