COFEPRIS Publishes New Guidance on Medical Device Registration via Equivalence and Abbreviated Pathways
In June, COFEPRIS released new guidance outlining the documentation requirements for medical device sanitary registration in Mexico through two…
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COFEPRIS Finalizes Medical Device Labeling Standard
On May 19, COFEPRIS published an updated medical device labeling standard, NOM-137-SSA1-2025, in the official Diario Oficial de la Federación (DOF). The update replaces…
New Medical Device Approval: Regulatory COFEPRIS Reforms
On August 22, 2025, as part of the new COFEPRIS regulatory reforms, the authority issued a new agreement concerning…
Expansion of Mexico’s Regulatory Pathway for Medical Devices
Mexico’s expedited regulatory medical device pathway, known as the Equivalence Route, was previously limited to recognizing marketing authorizations issued…
New List of Low-Risk and Deregulated Medical Devices in Mexico
On July 7, 2025, an updated Agreement including an updated list of low-risk and deregulated devices…
COFEPRIS Warehousing Compliance for Medical Devices
Learn about COFEPRIS warehouse requirements in Mexico for medical devices and IVDs, covering licensing, storage, and distribution compliance.
Technovigilance: PMS Reporting Requirements in Mexico
Learn about technovigilance requirements in Mexico for medical devices, including COFEPRIS compliance, adverse event reporting, and more.
Navigating COFEPRIS: Medical Device Distribution in Mexico
Mexico is one of the largest importers of medical devices in Latin America yet the importation process is highly…
Medical Device Registration in Mexico with COFEPRIS
Navigating medical device registration in Mexico with the Federal Commission for Protection against Health Risks (COFEPRIS) can be challenging for…
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