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 response on 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.

This includes information that is contained in the label for distribution purposes in Mexico or the modifications (if it is the case). 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 to change the local or foreign manufacturing site. *It is necessary to change the origin of the product (only for subsidiaries, branches or related). *It is necessary to change the contract manufacturer, either local or foreign: Issued to the manufacturing site.

1. veraqueconsulting.com/mx/good-manufacturing-practices-guide-for-mexico/

*It is necessary to change the local or foreign manufacturing site: FSC must be issued by the Ministry of Health from the Country of origin. *It is necessary to change the origin the product (only for subsidiaries, branches or related): FSC must be issued by the Ministry of Health from the Country of origin.

1. veraqueconsulting.com/mx/certificate-of-free-sales-issued-by-cofepris-and-requirements/
2. veraqueconsulting.com/mx/what-cofepris-requires-for-the-certificate-of-free-sale/

*It is necessary to change the local or foreign manufacturing site: 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. *It is necessary to change the origin of the product (only for subsidiaries, branches or related): 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. *It is necessary to change the contract manufacturer, either local or foreign: 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.

*It is necssary to change the contract manufacturer, either local or foreign: It must be dully certified by a Notary Public.

*It is necessary to change the medical device classification: stating the reason of the reclassification of the device. The reason must be based upon the level of product sanitary risk.

1. veraqueconsulting.com/mx/classification-and-grouping-ultimate-guide/

*It is necessary to change the primary or secondary packaging material: This may include the stability studies using the new packaging material, leakage tests and any other report proving the change is not affecting the device quality, safety and efficacy.

*It is necessary to change the expiration date: for medical devices that have an expiration date given their characteristics and intended use. Summary and conclusions for the Stability Studies on the proposed primary package supporting the new expiration date.