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  • 1.  MDL application to CA

    This message was posted by a user wishing to remain anonymous
    Posted 20-Sep-2022 09:07
    This message was posted by a user wishing to remain anonymous

    Hi all, 

    When submitting the application for MDL class II IVD kit, do you

    - just email to HC the application with the required documents? or
    - do you have to mail (fedex,..) the application as well? or
    - both?

    Any guidance is appreciated!

    Thank you.


  • 2.  RE: MDL application to CA

    Posted 20-Sep-2022 11:05
    Hello,
    For these MDL submissions, it depends on the size of your application.  I believe 20 MB is the cut-off for sending by email. More than that, you will require sending by mail with your submission on a USB stuck or burned on a CD.   


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    Karen Zhou
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    Original Message


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