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
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.
The Importance of sharing updated documentation in Medical Device distribution
In the medical device sector, safety and regulatory compliance are fundamental to ensuring quality and protecting patients. A key aspect of this process is traceability within the supply chain. As distributors, sharing updated information, such as the Notice of Operation and the Registration of the Tecnovigilance Unit, with the sanitary registration holder is not only a regulatory obligation but also an essential practice to ensure operational continuity and avoid setbacks in procedures with COFEPRIS.
Regulatory Update COFEPRIS proposes changes to NOM-240: Responsibilities for Manufacturers and Distributors (Updated)
The Ministry of Health in Mexico is proposing changes to a standard (NOM-240-SSA1-2012) regarding medical device safety and reporting. The draft standard strengthens reporting requirements for manufacturers, distributors and adds new responsibilities. Public feedback is welcome to evaluate the impact of the proposed changes.
