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  • 1.  Registering devices with Anvisa, Brazil

    Posted 27-Mar-2014 07:21
    Does anyone know if it is possible to register devices with Anvisa by not using a local Brazilian distributor? Or, does Anvisa require a LAR (Local Area Representative) to do this?

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    Jim Banic
    Regulatory Affairs Specialist
    Exactech, Inc
    Gainesville FL
    United States
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  • 2.  RE:Registering devices with Anvisa, Brazil

    Posted 28-Mar-2014 03:40
    Dear Jim,

    No, it is not possible to register devices in Brazil without a local distributor. It is mandatory to have a Brazilian representative with license (from local authorities - state and ANVISA) to distribute devices in Brazil.

    Best Regards,
    Claudia

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    Claudia Meneghisse PHD
    Tecan Schweiz AG
    Meilen
    Switzerland
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    Original Message


  • 3.  RE:Registering devices with Anvisa, Brazil

    Posted 28-Mar-2014 08:16
    Dear Jim,

    I agree with Claudia.

    Furthermore, check ANVISA -RDC185/2001, which is the primary regulation applicable to register all medical devices in Brazil, except for in vitro diagnostic devices.
    RDC 185/2001 describes the list of required documents and registration protocol to legally register a medical device in Brazil. If you follow the list, you will see that one of the documents required is the "Autorização de Funcionamento da Empresa (AFE), (it is like an "Company Operating Autorization"). This document is issued by ANVISA only for companies located in Brazilian territory. Therefore, companies based in another country that do not have subsidiares in Brazil, will need a Brazilian based third party, such as distributers and hosting companies.

    Kind regards
    -------------------------------------------
    Sinara Alves MBA,RPH
    CMS Produtos Médicos
    Anápolis - Goiás
    Brazil
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    Original Message


  • 4.  RE:Registering devices with Anvisa, Brazil

    Posted 28-Mar-2014 03:54
    There are 3 possibilites to register devices with ANVISA: open your own subsidiary (legal entity), find a local distributor, or work through a hosting company. I assume you cannot register medical devices from abroad.

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    Oscar Banz
    Head of QM & RA
    Haag-Streit AG
    Koeniz
    Switzerland
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    Original Message


  • 5.  RE:Registering devices with Anvisa, Brazil

    Posted 28-Mar-2014 07:35
    Dears, just to confirm that is mandatory to have registration trough a brasilian company, because some specific licenses are required, like AFE.

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    Ana Carolina M. Vianna
    JJGC Indústria E Comércio De Materiais Dentários SA
    Curitiba AL
    Brazil
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    Original Message


  • 6.  RE:Registering devices with Anvisa, Brazil

    Posted 28-Mar-2014 10:38
    Hello Jim,
    Yes, ANVISA require a Local Representative. You don't need to use a distributor, instead you can have a Regulatory Consultant Firm to be the license holder for you, and they will issue the Letter of Authorization for the distributors to import.
    Please, let me know if you have any additional question.

    Kind regards,
    -------------------------------------------
    Gabriela Martins Moreira
    Project Manager, International | Regulatory
    Microport Orthopedics Inc.
    Arlington TN
    United States
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    Original Message


  • 7.  RE:Registering devices with Anvisa, Brazil

    Posted 28-Mar-2014 11:47
    Jim,

    I have not found any other way to market products there without boots on the ground.

    Matt

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    Matthew Hull RAC
    Director RA/QS
    Consensus Orthopedics
    El Dorado Hills CA
    United States
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    Original Message


  • 8.  RE:Registering devices with Anvisa, Brazil

    Posted 28-Mar-2014 12:19
    Hi Jim,

    In accordance with Brazilian legislation there must be a BRH (Brazilian Registration Holder) for the device. This can either be an importer/distributor or a local import office established by the manufacturer in Brazil with all of the proper importation licences, etc.

    In either case the company must exist as a corporate entity in Brazil.

    Best regards,
    Michael

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    Michael Dun, RAC
    RA/QA Consultant
    Emergo Group
    Campinas
    Brazil
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    Original Message


  • 9.  RE:Registering devices with Anvisa, Brazil

    Posted 28-Mar-2014 15:41
      |   view attached
    Hi Jim
    You absolutely need a local agent in Brazil for device registration that would be your BRH (Brazilian Registration Holder). The BRH must hold a Company Working Allowance permit (IN No. 01/1994) from ANVISA which allows them to register, import, and distribute product. You should also sign a contract with them to protect the ownership and maintenance of the registration. Registrations cannot be transferred to another holder once the request is initiated so a switch in the BRH would require a new registration request. Product importation may be done by the BRH or the manufacturer (if you have a local office) with all necessary permits in accordance with Resolution RDC No. 81 of 5 November 2008 (regulation for importation of products) requirements (copy in Portuguese attached).

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    Maham Ansari, MS, RAC
    Regulatory Affairs Consultant
    Optum
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    Attachment(s)

    pdf
    11 RDC No 81-2008.pdf   663 KB 1 version
    Original Message