IPSNEWS
COFEPRIS adopts the MDSAP and NOM-241 equivalence
The publication in the Official Gazette of the Federation (DOF) refers to the Recognition of the Medical Device Single Audit Program (MDSAP) as equivalent to the Certificate of Good Manufacturing Practices (GMP), whose conformity assessment is based on NOM-241-SSA1-2025 Good Manufacturing Practices of Medical Devices.
Tariff Classification as a compliance tool
Tariff classification is, without a doubt, the most important step for any foreign trade operation. It represents the standard code that allows customs to unequivocally identify the merchandise and, based on it, apply the entire regulatory framework.
Keys to International Trade: EUR.1 and USMCA Certificates for Mexico
In foreign trade, competitiveness and operational efficiency largely depend on effective document management. Among the most important documents is the certificate of origin, which certifies the country where a product was manufactured and, in Mexico’s case, is essential for obtaining tariff reductions or exemptions under free trade agreements.
Big Changes at COFEPRIS! Mexico Simplifies Medical Device Registration and Advertising Notice
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.
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.
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.
Tariff Landscape for Medical Devices Mexico-U.S.
On April 2, 2025, the United States government announced the implementation of "reciprocal tariffs" on multiple countries, establishing a base tariff of 10%. However, a week later, a 90-day pause was applied for most trading partners; nevertheless, tariffs on China were simultaneously increased. This decision is part of a strategy aimed at correcting trade balance imbalances and strengthening the U.S. domestic industry.
Regulatory Update Mexico updates regulations with NOM-241-SSA1-2025
In Mexico, the Official Mexican Standard NOM-241-SSA1-2025, Good Manufacturing Practices for Medical Devices, has been published, updating the previous version issued in 2021. This modification, in addition to providing more explicit guidelines, aims to enhance regulatory alignment at the international level.
Innovation, Regulation, and Collaboration: A 10th Anniversary Interview with the CIB
In commemoration of the 10th Anniversary of the College of Biomedical Engineers of Mexico (CIB), IPS spoke with Montserrat Godínez, President of this important institution. This interview delves into the organization's milestones, challenges, and future aspirations.
Regulatory Update COFEPRIS Issues New Guidelines for certificate Good Manufacturing Practices
On March 20th of this year, the Federal Commission for Protection against Sanitary Risks (COFEPRIS) published the Guidelines that define the requirements for Certificates of Good Manufacturing Practices (GMP) or equivalent documents, necessary for sanitary registrations, renewals, and modifications.