Health Supplies

Regulatory Update New Agreement on Health Supply Import Permits Ensures Public Sector Access

Regulatory Update New Agreement on Health Supply Import Permits Ensures Public Sector Access

On December 4, 2024, an agreement was published in the Official Journal of the Federation (DOF), outlining the requirements for importing medicines and medical devices for the public sector. This agreement allows importing these products without a COFEPRIS sanitary registration, provided certain criteria are met. It aims to expedite supply processes, especially for consolidated purchases under BIRMEX scheme.

Regulatory Update Agreement on Equivalence of Sanitary Registration and Importation Requirements for Health Supplies

Regulatory Update Agreement on Equivalence of Sanitary Registration and Importation Requirements for Health Supplies

In 2020, Mexico implemented an agreement allowing expedited importation and equivalence of certain health supplies approved by recognized international regulatory bodies, aiming to address shortages and streamline access. However, an update in September 2024 nullified this agreement, requiring full compliance with Mexican regulatory processes for all health supplies.