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Minor changes in software need Anvisa submission?

  • 1.  Minor changes in software need Anvisa submission?

    This message was posted by a user wishing to remain anonymous
    Posted 08-Jun-2018 11:52
    This message was posted by a user wishing to remain anonymous

    • Can someone who is aware of Brazilian ANVISA regulation regarding changes in medical devices, for what kind of changes and whether need a change registration by ANVISA for even minor changes? What is the strategy to save time and money for the changes in order to continuously selling the products for major change and minor changes. If would be helpful if you could share a relevant regulation or a ANVISA link either in English and or in Portuguese. We at the moment is particularly concern about changes in labeling and device Embedded Software version number changes.


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