Regulatory Open Forum

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  • 1.  Adverse Event Reporting Australia

    Posted 01-Mar-2021 01:25

    Dear all,
    I know it was already asked before but I did not find satisfying answers. Can anybody provide a procedure or at least a flow chart for Medical Device Adverse Event Reporting in Australia?
    Thanks in advance!
    Best regards
    Christian



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    Christian Rosenzweig
    Consultant
    Marburg
    Germany
    ------------------------------


  • 2.  RE: Adverse Event Reporting Australia

    Posted 01-Mar-2021 09:59

    Hello Christian

    There's a nice description of the process on the TGA website: 
    https://www.tga.gov.au/medical-device-incident-reporting-investigation-scheme-iris
                      



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    Anne LeBlanc
    Manager, Regulatory Affairs
    United States
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  • 3.  RE: Adverse Event Reporting Australia

    This message was posted by a user wishing to remain anonymous
    Posted 03-Mar-2021 09:00
    This message was posted by a user wishing to remain anonymous

    I think , although the Australian regulatory guidelines for medical devices  (ARGMD) Part 3–Post-market Version 1.1, May 2011, is historical, the rules  are still applicable.



  • 4.  RE: Adverse Event Reporting Australia

    Posted 15-Mar-2021 05:42
    ARGMD is being updated into a continuously maintained online version.  See https://www.tga.gov.au/publication/australian-regulatory-guidelines-medical-devices-argmd which includes a tab for postmarket including incident reporting requirements and processes

    ------------------------------
    Arthur Brandwood PhD FRAPS
    Director and Principal Consultant
    Brandwood CKC
    Sydney, Australia
    Arthur.brandwood@gmail.com
    www.brandwoodckc.com
    ------------------------------



  • 5.  RE: Adverse Event Reporting Australia

    Posted 15-Mar-2021 05:46

    Hi CHristian,

    It's all described on detail on TGA website at https://www.tga.gov.au/reporting-problems where you can find info on device and medicine postmarket event reporting.

    Device reporting is now via a staged online form at https://apps.tga.gov.au/prod/MDIR/UDIR03.aspx

    There's also a public database (DAEN) of past reports (similar to FDA's MAUDE database) at https://www.tga.gov.au/database-adverse-event-notifications-daen

    Regards

    Arthur 



    ------------------------------
    Arthur Brandwood PhD FRAPS
    Director and Principal Consultant
    Brandwood CKC
    Sydney, Australia
    Arthur.brandwood@gmail.com
    www.brandwoodckc.com
    ------------------------------



  • 6.  RE: Adverse Event Reporting Australia

    Posted 15-Mar-2021 06:01
    Thank you very much for all answers! I appreciate your support a lot!
    Best regards
    Christian

    ------------------------------
    Christian Rosenzweig
    Consultant
    Marburg
    Germany
    ------------------------------