According to the Saudi FDA regulations, overseas medical manufacturers must appoint a local Authorized Representative. The Authorized Representative will act as a communication channel between the manufacturer and the Saudi FDA.
Kafou Medical deals directly with Regulatory Consultants to overseas medical manufacturers to grant the Saudi FDA approvals for their products.
Medical & Non-Medical Devices/IVDs licenses include but not limited to:
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Medical Device National Registry “MDNR”.
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Medical Device Establishment License “MDEL”.
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Medical Device Marketing Authorization “MDMA”.
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Medical Device Importing License “MDIL”.
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National Center for Medical Devices Reporting “NCMDR”.
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Product Classification System “PCS”.
