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.
This Decree, published in the Official Gazette of the Federation on June 2, 2025, establishes a regulatory framework aimed at promoting investment within Mexico to strengthen the pharmaceutical industry, the production of medicines, health inputs, and medical devices, as well as fostering scientific research. Its main objective is to reduce import dependency and ensure the availability of these essential products, using consolidated public procurement as a lever for economic development.
COFEPRIS is undergoing a significant transformation under "Plan México," aiming to become an agile, transparent, and internationally harmonized agency. This includes a push for 100% digitization of procedures, fostering clinical research, streamlining regulatory pathways, and modernizing the regulatory framework to boost investment and ensure public health.
In Mexico, cosmetic product labeling is regulated to ensure consumers receive accurate and sufficient information, enabling them to make safe and informed purchasing decisions. Compliance with these regulations is essential for manufacturers and importers looking to sell their products in the country.