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  • 1.  Saudi Implant Card Language

    This message was posted by a user wishing to remain anonymous
    Posted 19-Jul-2021 16:45
    This message was posted by a user wishing to remain anonymous

    With the new KSA requirement for an implant card becoming effective August 1 for some classes of devices, does anyone know whether there are language requirements for the card? Would it be possible to use English only, or is Arabic (and potentially other languages) also required?

    Our KSA contacts are all off for Eid al-Adha, so we are having trouble getting clarification on the requirements. 


  • 2.  RE: Saudi Implant Card Language

    This message was posted by a user wishing to remain anonymous
    Posted 23-Jul-2021 08:26
    This message was posted by a user wishing to remain anonymous

    Bumping this up to see if anyone has any feedback on the language requirements. Thank you!
    Original Message


  • 3.  RE: Saudi Implant Card Language

    Posted 25-Jul-2021 15:34
    Hello Anon

    I haven't seen a specific requirement​ on the implant cards, outside the UDI guidance: https://www.sfda.gov.sa/sites/default/files/2020-09/MDS-G34e.pdf

    Because implant cards are intended to be useful for the patients who receive them, I would expect they would follow the general guidance on labeling of medical devices, requiring both English and Arabic: https://www.sfda.gov.sa/sites/default/files/2021-01/%28MDS-G10%29ar%2Cen_1.pdf

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    Anne LeBlanc
    United States
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    Original Message


  • 4.  RE: Saudi Implant Card Language

    Posted 24-Jul-2021 14:05
    Arabic is also required , please send me email and will send you all required information 
    m.almoussli@gmail.com

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    Mona Al Moussli
    CEO
    Dubai
    United Arab Emirates
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    Original Message


  • 5.  RE: Saudi Implant Card Language

    This message was posted by a user wishing to remain anonymous
    Posted 03-Aug-2021 13:30
    This message was posted by a user wishing to remain anonymous

    Thanks to all for your expert feedback!
    Original Message


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