Understanding Mexico's New Abbreviated Pathway

This video provides medical device manufacturers with a step-by-step guide to navigating Mexico’s new Abbreviated Regulatory Pathway, which goes into effect September 1, 2025. Overseen by COFEPRIS, the pathway is designed to reduce approval times, harmonize Mexico’s regulatory framework with trusted global authorities, and accelerate patient access to safe and innovative medical devices. By accepting prior approvals from major regulators (including FDA, European Commission (MDR/IVDR), Health Canada, Swissmedic, ANVISA, TGA, NMPA, and more) COFEPRIS is signaling a shift toward regulatory convergence and global alignment.

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Topics covered in this video include:

• Mexico’s evolving regulatory landscape under COFEPRIS
• Key benefits of the Abbreviated Regulatory Pathway for manufacturers
• Expanded list of accepted international regulators and standards (FDA, EU, WHO, IMDRF, MDSAP, etc.)
• Requirements for eligibility under procedure COFEPRIS-04-050
• Technical and administrative documentation essentials
• New 30-business-day review timeline and its impact on market access
• Strategic implications for making Mexico a priority launch market

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Partner with Pure Global for Mexico Market Access‍

Pure Global’s Mexico regulatory team helps you prepare and localize your technical dossiers and acts as your in-country representative to manage interactions with COFEPRIS. With our expertise, you can minimize delays, stay compliant, and position Mexico as a priority launch market in your global expansion strategy. Learn more about COFEPRIS Mexico Medical Device Registration.

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