COFEPRIS Submission Mistakes That Delay Device Approvals
In 2025, Mexico’s COFEPRIS made major changes to its medical device regulatory process in which can produce common submission mistakes…
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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 medical…
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 by…
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 in…
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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