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

1. veraqueconsulting.com/mx/ultimate-guide-for-regulatory-affairs-in-mexico/
2. veraqueconsulting.com/mx/medical-device-regulatory-overview-mexico/
3. veraqueconsulting.com/mx/new-cofepris-submission-guide/

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

1. veraqueconsulting.com/mx/requirements-for-a-proper-medical-devices-warehouse-in-mexico/
2. veraqueconsulting.com/mx/nom241-for-medical-device-good-manufacturing-practices-in-mexico/

The most updated version including all the modifications up to date. For any pending responses fro COFEPRIS, provide such process receipt as well.

1. veraqueconsulting.com/mx/retroactive-renewals-for-medical-devices-in-mexico/

This is provided by your MRH Send notarized, original or certified copy of the power of attorney in favor of the Legal Representative of the Registration Holder established in Mexico.

The label designs should meet the requirements of the Mexican Labeling Norm NOM-137-SSA1-2008.

1. veraqueconsulting.com/mx/about-labeling-requirements-for-medical-devices-in-mexico/

Must match the IFU submitted to obtain the COFEPRIS registration.

*It is necessary for rights transfer: rights transfer agreement, where it is stated that the rights about the registration have been transferred to another Mexican Registration Holder. This must be signed by both the old and new MRH. *It is necessary for change manufacturer or distributor legal name: where it is stated that the company changed its legal name or. The document is requested in original or certified copy and must be certified by a Notary Public.

*It is necessary for rights transfer. *It is necessary for change or added a new distributor. Issued by the manufacturer, for any company to act as the new MRH. You will receive the template for the letter from the consultant during the dossier compilation process. Original or Certified Copies are required.

1. veraqueconsulting.com/mx/mexican-registration-holder-ultimate-guide/
2. veraqueconsulting.com/mx/medical-device-regulatory-overview-mexico/

*It is necessary for change the address of a local or abroad distributor: This is required in original but not legalized. *It is necessary to change manufacturer or distributor legal name: This document is requested in original or certified copy and legalized in the country of origin.