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  • 1.  UDI Requirements for Medical Device for Saudi Arabia (SFDA)

    Posted 05-Apr-2022 16:02
    Edited by Erion Kallushi 05-Apr-2022 16:03
    Guidance on Requirements for UDI for Medical Devices, v 3.0 (Saudi Arabia (SFDA)):
    Does anyone know when were these requirements implemented and when do manufacturer need to be compliant by? Also, when do the Implant cards need to be implemented by?


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    Erion Kallushi
    Regulatory Affairs Specialist
    Marlborough MA
    United States
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  • 2.  RE: UDI Requirements for Medical Device for Saudi Arabia (SFDA)

    Posted 06-Apr-2022 12:10
      |   view attached
    Dear Erion.

    See the attached file. Requirements for UDI include implant cards and therefore the timeline is the same. 


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    Melissa M. Traylor
    Regulatory Affairs
    FzioMed, Inc.
    San Luis Obispo, California
    USA
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    Attachment(s)

    pdf
    SFDAUDI (1).pdf   798 KB 1 version