Mexico’s regulatory landscape has been active, presenting important updates. Previously, we discussed the agreement published on June 11, 2025. However, as that version will soon be obsolete, this article has been updated to reflect the latest Agreement published on July 18 by the Mexican Ministry of Health in the Official Mexican Diary. This new agreement outlines the recognition of authorizations issued by reference regulatory authorities, as well as evaluations conducted under 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, especially in terms of timelines. In this article, we offer deeper insight into the changes
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 MDSAP and 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 from a 30 days working day revision period following submission.
Special Considerations for Authorization Validity
There are several key provisions to understand the relevance of this agreement:
- Article 16 emphasizes that this pathway may only be used for the same product authorized by the reference regulatory authority, which must have the same essential basic characteristics.
- Article 17 clarifies that if a product is registered in multiple reference countries, only one Certificate of Free Sales may be submitted. Therefore, using the registration from the country of origin, can help mitigate the risk of losing the Mexican registration if interest in another market is later withdrawn. Because, as article 18 states, the authorization document must remain valid throughout the application process.
- Article 20 highlights that eligible authorizations must have undergone a complete and independent regulatory review.
Noteworthy Additions to the Agreement
Articles 19 and 36 are especially notable, as they introduce elements not addressed in previous equivalency agreements:
- Article 19 addresses “duplicate submissions” and clearly states that applications submitted via this pathway that are already under review will be discarded.
- Article 36 establishes that COFEPRIS will not request any documentation or information beyond what is outlined in the current agreement. This unprecedented provision signals a commitment to streamlined processing.
Although the agreement sets a standard processing timeline of 30 working days, submitting under this regulatory framework may offer strategic benefits. Given its recent implementation, applications filed through this pathway may receive increased attention from Mexican authorities, offering a potential advantage in prioritization and potentially expediting approvals.
Frequently Asked Questions (FAQ)
- Are the 30 days promised by COFEPRIS counted as calendar days or working days?
The 30-day review period established under this equivalency agreement refers to working days (business days), not calendar days. This distinction is critical for regulatory planning, as weekends and official holidays are excluded from the timeline.
- Which foreign regulatory agencies are accepted by COFEPRIS for medical device equivalency approvals in Mexico?
COFEPRIS recognizes authorizations issued by regulatory agencies that are members of the IMDRF Management Committee or operate under MDSAP, as well as WHO Prequalification decisions. These include, among others:
- United States – FDA (Food and Drug Administration)
- Canada – Health Canada
- European Union – EMA / National Competent Authorities
- United Kingdom – MHRA
- Japan – PMDA
- Australia – TGA (Therapeutic Goods Administration)
- Brazil – ANVISA
- China – NMPA (National Medical Products Administration)
- South Korea – MFDS (Ministry of Food and Drug Safety)
- Singapore – HSA (Health Sciences Authority)
- Switzerland – Swissmedic
- Russia – Roszdravnadzor
Medical devices and IVDs approved by these agencies may qualify for the Mexican regulatory equivalency pathway, provided all other requirements are met.
- Can a product authorized in multiple reference countries be submitted under this pathway?
Yes. If a medical device or IVD is registered in more than one reference country, only one Certificate of Free Sale (CFS) is required for submission. Strategically, using the authorization from the country of origin is often advisable, as the selected reference authorization must remain valid throughout the entire COFEPRIS review process. If that authorization is withdrawn or expires, the Mexican application may be affected.
Conclusions
The agreement officially goes into effect on August 29, 2025, making this a crucial period for medical device industry stakeholders seeking to leverage regulatory efficiencies in Mexico.
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.