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.
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.
COFEPRIS has implemented a series of simplification and modernization measures aimed at streamlining procedures and reducing the regulatory burden for establishments. These actions are part of the federal government’s regulatory improvement policies. This update specifically applies to the Operating License.
COFEPRIS has published a new agreement recognizing the evaluations and approvals from key international regulatory authorities and the WHO Prequalification Program for sanitary registrations of medicines and medical devices. This move, effective 60 business days after publication, aims to expedite access to quality health inputs by adopting a "reliance" approach, simplifying import procedures for essential products during health crises.
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.
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.
