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  • 1.  TGA recall

    This message was posted by a user wishing to remain anonymous
    Posted 12-Dec-2022 10:02
    This message was posted by a user wishing to remain anonymous

    Hi,

    We are based in Australia and recently TGA asked us to do a recall (Class III) for performance issues for a class IIb device where the device is rendered unusable ( its not a life saving device). 

    Is this reportable for any other jurisdictions  ? Is it necessary to inform all overseas distributors of this recall ? Yes , its on the TGA website , however should we clarify when asked or do we need to announce to all?




  • 2.  RE: TGA recall

    Posted 13-Dec-2022 11:40
    Generally each jurisdiction has slightly different criteria for conducting a recall. Given that you are indeed doing one in one geography, you should assess the situation against each of the others specific criteria. If it meets the criteria, obviously you should do the recall there. If it does not, document your assessment in your file.

    1) that shows any auditor you did it, and
    2) I can guarantee that you will get calls from other jurisdictions who read the website or share info internally - and you now have an assessment to send to them

    Ginger

    ------------------------------
    Ginger Glaser RAC
    Chief Technology Officer
    MN
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    Original Message


  • 3.  RE: TGA recall

    Posted 14-Dec-2022 10:03
    Morning all,

    It is also the case that many health authorities want to know about foreign action taken which might affect patient safety and a recall would most definitely fall into this category. Health Canada requires reporting on medical device recalls related to serious health risks in another jurisdiction for devices licensed in Canada. Importers in Canada should include the requirement to be informed of foreign actions and recalls in their quality agreements. 



    Original Message


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