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  • 1.  Mexico Registration of Dossier requirements

    Posted 26-Apr-2023 11:40

    Hi,

    If we have registered product in USA, I want to register for Mexico market, what will be regulatory requirement?

    Do we need to submit full dossier to Mexico registration body?

    Regards,
    Sapna



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    sapna rathi
    Regulatory specialist
    AHME
    India
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  • 2.  RE: Mexico Registration of Dossier requirements

    Posted 27-Apr-2023 07:14
    Hi Sapna,

    If your product is already FDA approved, you can choose the submission route by equivalence with the FDA. This route is supposed to have the following benefits:

    - Less technical and legal documentation is requested by COFEPRIS

    - The review and approval times are shorter

    - Reduced translation costs


    This kind of requests are not eligible to be reviewed by an authorized third party. Therefore, COFEPRIS will review them directly with more strict criteria and the documents and information submitted must be correct to avoid delays and take advantage of this fast track route.


    Regards,


    Guillermo




    Original Message


  • 3.  RE: Mexico Registration of Dossier requirements

    Posted 27-Apr-2023 07:48
    Yes you do a complete dossier with even more information than in the US
    Cofepris is the HA in Mexico and they require to include chromatograms of batches placed on stability and a lot more information

    Sent from my iPhone


    Original Message


  • 4.  RE: Mexico Registration of Dossier requirements

    This message was posted by a user wishing to remain anonymous
    Posted 28-Apr-2023 08:08
    This message was posted by a user wishing to remain anonymous

    Applicable data from the US product could be leveraged for the Mexico dossier. If the US product is launched on the US market, a certificate to foreign government from the US FDA may need to be included in the Mexico dossier.


    Original Message


  • 5.  RE: Mexico Registration of Dossier requirements

    Posted 16-May-2023 13:29

    For instance, the device under the risk Class I in the USA may not have the same classification in Mexico. It is recommended that manufacturers begin the device registration process with the classification and grouping of the device as per the medical device classification rules set forth by the COFEPRISAs a foreign manufacturer, you are required to appoint a Mexican Registration Holder (Representante Legal) who will act as the local representative for your company in Mexico. The Registration Holder will assist with the registration process and regulatory compliance. All devices approved under various US FDA Regulatory pathways for medical devices qualify for the Equivalency Review pathway.
    Class 1 exempt is a challenge;the main issue is that the US FDA's Establishment Inspection Report (EIR) is not available. In the USA, the majority of Class I devices are free from GMP requirements and call for establishment registration and device listing. Manufacturers may choose to submit either the ISO 13485 certification or the MDSAP (Medical Device Single Audit Programme) certification in place of the EIR, as COFEPRIS accepts both.



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    Raje Devanathan
    Amerisource Bergen
    TPIreg, Innomar Strategies
    Senior Manager - Regulatory Affairs, Medical Devices
    rdevanathan@tpireg.com
    3470 Superior Court
    Oakville ON L6L0C4
    Canada
    ------------------------------

    Original Message


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