On June 11, 2025, the Mexican Ministry of Health published a new Equivalency Agreement in the Official Mexican Diary. This agreement recognizes the equivalency of authorizations from reference regulatory authorities, as well as evaluations from the World Health Organization (WHO) Prequalification Program.
This update is important if your medical device or IVD has been approved by a regulatory authority of reference. Specifically in terms of timelines. In this article, we provide more details about it.
Regulatory Equivalency and Expanded Recognition
As a reference, Mexico has previously implemented equivalency agreement models as a mechanism for streamlining regulatory approval processes. Prior to this update, Mexico acknowledged authorizations from Canada, Japan, and the United States.
However, with this latest agreement, COFEPRIS has extended recognition to the IMDRF (International Medical Device Regulators Forum) Management Committee, which as of 2025 includes Regulatory Agencies from:
- Australia
- Brazil
- Canada
- China
- European Union
- Japan
- Russia
- Singapore
- South Korea
- Switzerland
- United Kingdom
- United States of America
In other words, medical devices and IVDs approved by Regulatory Agencies from these countries are eligible for the equivalency agreement and would benefit with a 30 days working day revision period upon submission of the documents.
Critical Considerations for Authorization Validity
It is essential to highlight that, under Article 9 of this agreement, authorizations must have undergone a complete and independent review. This implies that COFEPRIS will not necessarily reduce the documents they currently request for any actual regulatory pathway.
It is expected that submitting regulatory processes under the framework of this new agreement can be a strategic move, regardless of the officially stated processing timelines (30 working days upon submission). This is because, given its recent implementation, this equivalency agreement may receive increased attention from Mexican authorities, offering a potential advantage in prioritization and potentially expediting approvals.
Notes
The agreement officially takes effect in the first week of September 2025, making this a crucial period for medical device industry stakeholders seeking to leverage regulatory efficiencies in Mexico. During this period, further instruments related to this agreement are expected to be published. We will be notifying you through our webpage and newsletter.
If you are interested in further understanding the equivalency agreement process, you will find the following articles interesting:
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.
