Regulatory Open Forum

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  • 1.  Medical Device Clinical trials in Brazil

    Posted 29-Jun-2015 11:57

    I am trying to understand the process is for conducting a clinical trials in Brazil of a medical device.  The ANVIZA website is not very detailed re: application process.  Can anyone point me in the right direction for the applicable regulations in English?

    Thanks!  
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    Georgiann Keyport RAC
    Sr. Partner
    Chaska MN
    United States
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  • 2.  RE: Medical Device Clinical trials in Brazil

    Posted 29-Jun-2015 17:23
    Georgiann,

    Unfortunately not all ANVISA's regulations are translated to English. If you are interested, I would be pleased to help you understand some of the procedures. Please let me know.

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    Marcela Saad MSc, PharmD, RAC Global
    President & Senior Consultant
    MarcM Consulting Canada
    Kitchener ON
    Canada
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    Original Message


  • 3.  RE: Medical Device Clinical trials in Brazil

    Posted 30-Jun-2015 10:03
    Good morning Georgian,

    I read the requirements for CT of MD in Brazil a while ago and would need to review before providing you with details.  I am native Brazilian and would be able to read all regulations in either language.  If you are interested, please contact me.  

    Valeria

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    Valeria Sena-Weltin RAC
    Sr. Regulatory Affairs Associate
    New Market MD
    United States
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    Original Message


  • 4.  RE: Medical Device Clinical trials in Brazil

    Posted 01-Jul-2015 05:34

    Dear Georgiann

    ANVISA has published this year the RDC 10/15 with the requirements of clinical trials for medical devices in Brazil.
    You can see this resolution on the link below:
    http://pesquisa.in.gov.br/imprensa/jsp/visualiza/index.jsp?data=03/03/2015&jornal=1&pagina=73&totalArquivos=140

    However, ANVISA hasn't published an English version of this (and I don't still have one).

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    ANDRE JOCHEN RAC
    SAO PAULO
    Brazil
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    Original Message