The payment is performed by the MRH. The receipt must be included in the final dossier.

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All Mexican distributors are legally required to have these notices. An electronic copy of the notice(s) is sufficient for the application.

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The most updated version. For any pending sanitary registration response in COFEPRIS provide the process receipt as well.

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issued by the MRH giving the legal representative the authority to apple for renewals before COFEPRIS. Anoriginal or Certified Copy is required.

Labels currently in use should meet the requirements of the Mexican Labeling Norm NOM-137-SSA1-2008, as devices have already been on the market for five years. Examples of the physical labels stuck/printed on the packages work very well.

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Must match the last IFU submitted to obtain COFEPRIS Registration.

Besides the Technovigilance (TV) report that covers the last 4 years (for the first renewal) or 5 years (for the subsequent renewals) of operation and any adverse incident, include the response from the CNFV , stating that the report already submitted follows the applicable regulation. This report must be maintained by the manufacturer, who will keep it up to date and ensure information is complete and accurate.

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Issued by the manufacturer, for any company to act as your Mexican Registration Holder.You will receive the template for the letter from the consultant during the dossier compilation process. Original or Certified Copies are required.

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You will receive the template for the letter from the consultant during the dossier compilation process. Original or Certified Copies are required

Coded certificate issued within the last year, including the device to be registered to COFEPRIS. Original or Certificated copy.

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It must include: description, intended of use, codes or presentations, formula and/or compositions, shelf life, when applicable, sterility period, primary and secondary packaging description. Original or Certificated copy

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It must include: description, intended of use, codes or presentations, formula and/or compositions, shelf life, when applicable, sterility period, primary and secondary packaging description. Original or Certified copy.

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It must include: description, intended of use, codes or presentations, formula and/or compositions, shelf life, when applicable, sterility period, primary and secondary packaging description. Original or Certified copy

1. veraqueconsulting.com/mx/mdsap-and-how-to-use-it-in-mexico/