Mexico launches abbreviated regulatory pathway for medical devices

In Mexico, regulatory authority COFEPRIS announced a new Abbreviated Regulatory Pathway for medical devices, effective September 1, 2025. The pathway allows device manufacturers to leverage existing approvals from international reference authorities (members of IMDRF or MDSAP) and importantly reduces documentation requirements, with a decision timeline of up to 30 business days. 

The July 18 2025 agreement stipulates that COFEPRIS will recognize decisions by other regulatory authorities as equivalent provided they meet safety, quality and efficacy standards and were not granted solely via emergency or accelerated mechanisms. 

For device-manufacturers aiming at Latin America, this reform effectively shortens the time to market in Mexico and positions the country as a potential priority launch market in the region. Analysis shows the reduced timeline and document duplication removal significantly improve market-entry prospects. 

Sources:

• “Mexico COFEPRIS 2025 Abbreviated Pathway for Medical Devices – PureGlobal.” Aug 6 2025. Link 

• “Mexico Expands Health Product Registration Process with New Guidelines.” RRMA Global, Aug 13 2025. Link