When seeking sanitary registration for medical devices in Mexico through COFEPRIS, companies have traditionally followed one of two routes: the ordinary process or the fast-track equivalency agreements. From those, the equivalency pathway has become a central topic of discussion following the implementation of the Expanded Equivalency Agreement.
This article outlines the implications of the recently published Simplification Agreement, which officially renders previous equivalency agreements obsolete as of October 3, 2025.
Background: Shifting Regulatory Pathways in Mexico
Until recently, the two main registration options were
- Ordinary/ Standard Registration Process
- Equivalency Agreements (commonly referred to as fast-track approvals)
However, on August 22, 2025, the Official Mexican Gazette published the Simplification Agreement for Procedures at COFEPRIS. This regulation introduces major changes, most notably on the elimination of prior equivalency agreements.
Obsolete Agreements: What is Being Phased Out?
Since 2010 and 2012, Mexico had adopted equivalency models recognizing regulatory authorizations from:
- Canada
- United States
- Japan
Each pathway had a designated unique procedure code (homoclave) for submission. Under Article 6 of the Simplification Agreement, these codes will be removed, effectively retiring:
The New Pathway: Expanded Equivalency Agreement
In response, COFEPRIS has introduced a single, unified pathway for equivalency-based registration:
- Code COFEPRIS-04-050: Application for Sanitary Registration of Medical Devices via Equivalency with Reference Regulatory Authorities
This new route incorporates reference authorities aligned with MDSAP and IMDRF as detailed in our previous article: Mexico’s Expanded Equivalency Agreement for Medical Devices: Key Implications
The updated process promises approval timelines of 30 business days, enhancing access to the Mexican market.
Additional Implications: Accelerated Timelines for Ordinary Process
Interestingly, Article 5 of the Simplification Agreement suggests that the ordinary registration process will now offer timelines comparable to the equivalency agreement route.
Estimated processing times by device class are:
|
Device Class |
Estimated Timeline |
|
Class I |
20 business days |
|
Class I (Low Risk) |
15 business days |
|
Class II |
25 business days |
|
Class III |
35 business days |
These timelines are indicative and may be subject to extension in practice.
Conclusions
The Simplification Agreement marks a pivotal shift in Mexico’s regulatory landscape for medical devices. With its official implementation on October 3, 2025, stakeholders must reassess their registration strategies to align with the new framework and leverage available efficiencies.
If you have questions or comments regarding this new equivalency agreement, feel free to contact Veraque . You can also subscribe to our LinkedIn newsletter to stay connected, and ensure you never miss regulatory insights.
