IPSNEWS
COFEPRIS Enables Regulatory Reliance Through Abbreviated Pathway
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.
Unlocking Efficiency: COFEPRIS Modernizes Regulatory Framework
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.
Keys to the Labeling of Dietary Supplements in Mexico
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.
COFEPRIS Modernizes Medical Device Framework: What You Need to Know
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.
Simplification of Operating License and Modification Process for Products and Services
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.
Convocatoria para asistir a Korea Sourcing Week - 2025
Este año, IPS colaborará estrechamente con Korea SMEs and Startups Agency (KOSME) para convocar e identificar a dos grandes compradores mexicanos del sector cosmético interesados en participar en Korea Sourcing Week 2025, que se llevará a cabo del 3 al 6 de septiembre en Ilsan, Corea del Sur.
Classification Query: A Regulatory Tool for Marketing Your Cosmetics and Dietary Supplements
The classification query submitted to the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) is a crucial step in regulating cosmetic products and dietary supplements.
Keys to Efficient Medical Device Importation in Mexico
Importing medical devices into Mexico involves a series of steps regulated by health and customs authorities. Due to their impact on public health, these products must meet specific requirements from their origin through to commercialization. Therefore, proactive planning and specialized advice are essential to avoid setbacks.
Revolutionizing Health Product Access in Mexico: COFEPRIS Embraces Global Regulatory Reliance
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.
Health Transformation: Key Incentives for Investment and Scientific Development in Mexico
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.