Portugal Local Networking Group

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  • 1.  Regulatory Brasil ANVISA

    Posted 10-Feb-2023 07:03

    Hy everyone!

    I'm looking for current guidelines for registering medical software in Brazil. I know that the regulations have recently changed. Do you know where I can find this information? Classification? Registration? Costs?


    Thanks



    ------------------------------
    Ana Clemente
    QMS & Regulatory Affairs
    Portela
    Portugal
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  • 2.  RE: Regulatory Brasil ANVISA

    Posted 10-Feb-2023 07:42
    Hello Ana,
     
    We can help you, I have a team member with experience in the ANVISA process! please get in touch with us!
     
    regards,
     
    Sandra Balseiro
    Head of MD/IVD Regulatory Support Unit
    Laboratory for Automatics and Systems
    t:+351 910 138 502
    Instituto Pedro Nunes
    Association for Innovation and Development in Science and Technology
    Rua Pedro Nunes 3030-199 Coimbra - PORTUGAL
    http://www.ipn.pt | http://twitter.com/IPNunes | http://www.facebook.com/institutopedronunes