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  • 1.  Significant change - Brazil

    This message was posted by a user wishing to remain anonymous
    Posted 16-Mar-2022 09:16
    This message was posted by a user wishing to remain anonymous

    Hi ,

    Does anybody have guidelines for assessing device changes for Brazil market.

    tx


  • 2.  RE: Significant change - Brazil

    Posted 17-Mar-2022 05:00
    Hi, 

    A year or two ago the RDC was modified to have three categories of changes, distinguising between ones that can be implemented immediately (without submission), others can be implemented pending submission, and others after approval of the submission for the change. I cannot recall the RDC number, but I quickly googled and found this article. 

    https://www.thema-med.com/en/brazil-new-rules-for-medical-devices-design-changes/

    Also MDSAP companion book includes some guidance on examples of changes that are considered significant.

    I hope this helps.

    Daniela

    ------------------------------
    Daniela Mahan Soler Esq, RAC
    Regulatory Affairs Manager
    Munich
    Germany
    ------------------------------

    Original Message


  • 3.  RE: Significant change - Brazil

    This message was posted by a user wishing to remain anonymous
    Posted 21-Mar-2022 09:44
    This message was posted by a user wishing to remain anonymous

    thanks Daniela, appreciate your help
    Original Message


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