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  • 1.  Class I Medical Devices Manufacturer - Brazil - ANVISA Regulations.

    This message was posted by a user wishing to remain anonymous
    Posted 28 days ago
    This message was posted by a user wishing to remain anonymous

    Hello RAPS Team, 

    What are requirements for Class I (Non sterile, Non Measuring) Medical Devices foreign manufacturer  to send devices to Brazil as per their regulations?

    Do we need REP in Brazil like EU REP?


    Is distributor in Brazil enough to import and sell devices in Brazil?

    Does distributor in Brazil, need to list, devices data in their database just like PARD and FDA listing database?
    Would appreciate your assistance.

    Thanks



  • 2.  RE: Class I Medical Devices Manufacturer - Brazil - ANVISA Regulations.

    Posted 27 days ago

    Anon,

    Class I devices submit a Cadestro to ANIVSA which is a type of notification for marketing in the country.  This is similar to other medical device registrations in other countries for lower risk Class I devices; but the application still needs to be made.

    If the Manufacturer is located outside Brazil, then a Brazilian Registration Holder (BRH) is needed.  This is somewhat similar, but not the same as a EU REP because the BRH takes a much more active role in the submission and continued maintenance process.  It would be recommended to not use a distributor for this role because there are "ownership" of registrations which needs to be considered - it should be an independent entity.  You might want to seek some expert advice on this because although it is Class I, there are still many activities which must be done especially if located outside Brazil.



    ------------------------------
    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Principal Strategy Consultant
    NAMSA
    ------------------------------

    Original Message


  • 3.  RE: Class I Medical Devices Manufacturer - Brazil - ANVISA Regulations.

    Posted 27 days ago

    Good Day Anon,

    The regulations for Class I devices as you describe have recently changed.  However, Manufacturers without an established place of business in Brazil must appoint an in-country representative known as the Brazil Registration Holder (BRH). The BRH submits the registration application and is also involved in post-market surveillance. The BRH is considered the "owner" of the registration.  Appoint a company that holds a Company Working Allowance permit from ANVISA as your Brazil Registration Holder (BRH).

    The following are required for registration:  

    LoA, technical file and application forms according to RDC not submitted but held by BRH for on-site inspections.

    BRH submits application forms, labels and IFU in Brazilian Portuguese.

    You can have multiple BRH but each must hold their own registration.



    ------------------------------
    D Michelle Williams
    VP - Operations
    United States
    ------------------------------

    Original Message


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