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  • 1.  TGA - Comparable overseas regulators (IVDs)

    Posted 11-Jan-2023 22:55

    Dear Colleagues,

    https://www.tga.gov.au/sites/default/files/use-market-authorisation-evidence-comparable-overseas-regulators-assessment-bodies-medical-devices-including-ivds.pdf

    With regards to TGA's changes published in Sep '22, ver 1.7, would you be able to advise on the inclusion of Class 2 IVDs, as I have come to a conflicting information on pg 22 (please see attached screenshot).

    TGA - IVDs
    Many thanks!



    ------------------------------
    AnaCiric
    RA/QA Specialist
    Singapore
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  • 2.  RE: TGA - Comparable overseas regulators (IVDs)

    Posted 11-Jan-2023 23:40
    That's a formatting error, some one has selected to repeat the first two rows of the table on each page, that row does not belong there (or on the subsequent pages)

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    Rob Parbery
    Balmain NSW
    Australia
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    Original Message


  • 3.  RE: TGA - Comparable overseas regulators (IVDs)

    Posted 16-Jan-2023 01:34
    Hi Rob,

    Thank you for pointing that out!
    Best,

    ------------------------------
    AnaCiric
    RA/QA Specialist
    Singapore
    ------------------------------

    Original Message


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