The Mexican market is complex and diverse, so it's essential to have a tailored strategy for each product.
IPS is a leading provider of regulatory services for the health industries in Mexico. We help manufacturers and distributors of medical devices, dietary supplements, and cosmetics navigate the complex Mexican regulatory landscape. Contact us today to learn more.
On July 11, 2025, COFEPRIS published a landmark Agreement in the Official Gazette of the Federation, marking a decisive step toward the nationwide simplification and modernization of sanitary procedures.
Dietary supplements are defined as products intended to increase or complement the total dietary intake, or to supply one or more of their components. COFEPRIS is the authority in Mexico responsible for regulating these products and for establishing the labeling requirements they must meet to be marketed in the country.
On July 7, 2025, Mexico’s regulatory authority, COFEPRIS, issued a new decree that substantially revises the classification framework for medical devices, thereby formally repealing the agreements published in 2011 and 2014.