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

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2. veraqueconsulting.com/mx/medical-device-regulatory-overview-mexico/
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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 original registration and all its modifications must be presented on front in order to receive the renewed registration. 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 appply for renewals before COFEPRIS. An original 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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Submit certificates of analysis of recently manufactured devices. It will prove that the devices that are being sold in the country are still meeting the specifications of quality, safety and efficacy. Certificate of Conformance, 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.

Original or Certified Copy Please also provide legalized copies of the GMPC for all your contract manufacturers (if applicable).

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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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2. veraqueconsulting.com/mx/medical-device-regulatory-overview-mexico/

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