The mexican registration Holder (MRH) pays. The receipt must be included in the final dossier.

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It distributors will not be added to the registration at this time, they must be added later through a modification process.

All mexican distributors are legally required to have these notices. An electronic copy of the notices is sufficient for the registration.

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Issuing authority to the legal representative in order to apply for renewals and/or registration submission to COFEPRIS. An original or certified copy is required.

Simple copy of the document.

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Labels must be in Spanish, and should meet the requirements of the Mexican Labeling Norm NOM-137-SSA1-2008. Whenever Mexican Labels are not yet finalized and compliant, it is necessary to prepare and submit the Label Design.

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This document must describe the device perfectly. Besides, this monography must provide evidency that the medical device is compliant within specifications and has approved tests and applicable standards. The devices included in this document must match the other submitted documents, such as EIR (Establishment Inspection Report), CFG (Certificate to Foreign Government), MDL (Medical Device License), etc. For the overviews to be acceptable, they must be specific about the product, including the lot number, device names, test conditions, acceptance criteria, results and conclusions, as applicable.

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At least the following information must be provided: Name, Description of the product, intended use and directions of use, list of product components or parts, assembly and disassembly instructions, operating and clean up instructions, operation conditions and storing, warnings, cautions, contraindications and adverse events, other as applicable (maintenance, calibration, preparation), for contrast media, indicate route of administration, pharmaceutical form and content of active ingredient per dose unit.

Certificates of Analysis for the finished product are mandatory by COFEPRIS for the submission. Certificates of Analysis for the raw materials are required in cases where the raw material comes into contact with the human body. Certificate of Conformance or the DHR (Device History Record) test reports are also acceptable to meet this requirement. Your consultant could provide further assistance to prepare this document, if needed.

Report summarizing latest post marketing surveillance of the product. It includes al adverse events recorded since the product was first made available on the market (if applicable). It also includes the corrective and preventive actions taken.

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This doesn’t need to be submitted to COFEPRIS, but it needs to be kept on file by the Mexican Registration Holder.

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.

Original or Certified Copy The CFG must include the medical device to be registered in Mexico. It should include all the codes or presentations listed in the Mexican dossier It must be valid upon the dossier submission

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The EIR correspond to the last audit performed by the FDA to the manufacturing facility to confirm GMPs. Original or Certified Copy.

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The document that provs that the device to be registered in Mexico is in compliance with the directives in USA. Original or Certified Copy. For class III devices, it may apply the premarket notification 510(k) (PMN) or the premarket approval (PMA).

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License issued by Health Canada that proves the device to be registered in Mexico has been approved in Canada. It must match the product and its presentation to be registered before COFEPRIS.

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The certificate must include the SCC seal, that demonstrates that the registrar has been recognized by the Canadian MoH. Original or Certified copy.

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Certificate of the Management Systems Accreditation Program issued by the SCC that shows the scope of the registrar who performed the audit and issued the ISO 13485 certificate. Simple copy.

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Issued by the SCC for the registrar that issued the ISO 13485 certificate. Must be valid at the moment of the submission to COFEPRIS.

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