Mexico's regulatory authority, COFEPRIS, has introduced a landmark agreement to modernize its regulatory processes. For medical devices, multiple submission categories for new registrations and renewals are now consolidated into a single, unified procedure. This reform streamlines submissions and shortens review timelines considerably. Additionally, the agreement introduces updated requirements for advertising notices.
On August 11, 2025, the Agreement establishing actions for the simplification of procedures before the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) was published in the Official Gazette of the Federation (DOF).
On July 18, 2025, COFEPRIS published the Agreement outlining the General Guidelines for the application of the Abbreviated Regulatory Pathway for granting sanitary licenses for medical devices and drugs.
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.
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.
The cosmetics industry in Mexico is subject to a robust regulatory framework enforced by the Federal Commission for Protection against Health Risks (COFEPRIS). This oversight aims to safeguard consumer health and ensure product safety and quality. Given the growing popularity of cosmetics, understanding these regulations is crucial for businesses operating within this sector.
