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.
COFEPRIS Modernizes Medical Device Framework: What You Need to Know
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.
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.
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.
