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  • 1.  Mexico medical device database

    Posted 25-Feb-2021 18:28
    Hello everyone,

    My company is looking to expand into Latin America and have a question.  Does Mexico have a medical device approval database?   

    Any help and advice would be greatly appreciated.

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    Johnathan Akers
    Regulatory Associate
    Apex NC
    United States
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  • 2.  RE: Mexico medical device database

    Posted 26-Feb-2021 05:42

    Dear Jonathan, yes you can see the list of new registered devices from 2017 to through most of 2020 currently by year of their sanitary registration in Mexico on the COFEPRIS website.

     

    Navigate to the link below and then scroll to where it says Documentos and you will see a listing of all devices registered by Year. These are PDF files of the device registrations in Spanish most recently published in 2020 and going back to 2017.

     

    https://www.gob.mx/cofepris/documentos/registros-dispositivos-medicos

     

    Hope that helps.

     

    Dallas L. Thomas, RAC, MHA, MPA,

    Medical Device Consultant

    Florida, USA

    Connect on Linkedin

    Follow us on Twitter: @RegulatoryThom  Connect on Alignable 

     

    Hablo Español / Falo Português

     

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    Original Message


  • 3.  RE: Mexico medical device database

    Posted 26-Feb-2021 10:38
    Hello Jonathan,

    Dallas gave the good information.  I would like to add a comment from my Mexican colleagues - this is not an "active" database so quite similar to the FDA's 510(k) database in that kinda "written in stone".  It basically shows when devices were registered but it is not updated with information like transfers or removals.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


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