Abbreviated Pathway Reference Authorities: IMDRF Members and MDSAP

1. Key takeaways

For medical devices, the Mexican abbreviated pathway relies on decisions issued by regulatory authorities of countries that are members of the IMDRF Management Committee, and on GMP certificates issued under the MDSAP framework. The reference approval must have been obtained through a conventional procedure, must not be older than 5 years, and emergency use authorizations, accelerated approvals and conditional approvals are never eligible. These rules come from the abbreviated pathway guidelines and they define who can serve as a reference authority at all. Getting the list right is the first gate in pathway selection: an application built on a non-qualifying approval will be redirected to the standard route, together with its full documentation burden. The checks that matter are the identity of the issuing authority, the procedure under which the approval was granted, and the date on which it was obtained, and all three must be verified against the approval document itself rather than against marketing claims about it. This page walks through the acceptable authorities, the special role of MDSAP certificates, the age limit on reference approvals, and the transition away from the older bilateral equivalence agreements that these guidelines superseded.

2. Legal basis

The current reliance framework rests on the 2025 guidelines, while the earlier bilateral equivalence agreements with the United States, Canada and Japan have been superseded. The homoclave agreement marks the cut-off date after which the old routes ceased to be accepted, which makes the table below useful both for confirming eligibility today and for closing out any legacy documentation that still cites the earlier agreements. The table below lists each instrument with its date and the point it establishes.

3. Expert insights

Insight 1: the reliance lists for devices and for drugs are different. The guidelines provide that drugs rely on the founding members of ICH or standing regulatory authorities, including the EMA and the FDA, as well as on WHO prequalification; devices, by contrast, rely on the members of the IMDRF Management Committee and on MDSAP. Mixing the two lists is a direct route to selecting the wrong pathway. A team working on a combination product or on adjacent device and drug portfolios must check the correct list for each product category separately.

Insight 2: the role of MDSAP in the list is as quality system evidence. GMP certificates issued by MDSAP members can be used to satisfy the quality system requirements, which is a separate matter from reliance on a product approval. Holding an MDSAP certificate does not by itself make the product eligible for the abbreviated pathway; what matters additionally is which regulatory authority issued the product approval. The two credentials answer two different questions and must be filed as two different pieces of evidence.

Insight 3: the 5-year figure is an age limit on the reference approval. The guidelines require that the approval issued by the reference regulatory authority have been obtained within 5 years. An older approval remains perfectly valid in its own country, yet once it exceeds this window it can no longer support the abbreviated pathway. Renewal of the reference approval is therefore a scheduling lever: where the Mexican filing is being planned, the age of the reference certificate should be checked first, before any dossier work is commissioned. Because certificate ages are easy to overlook, this is the condition most often discovered late, after the dossier strategy has already been built around the faster route.

Insight 4: the type of approval is a more common pitfall than the identity of the authority. Approvals issued by the very same qualifying regulatory authority are excluded if they were granted as emergency use authorizations, accelerated approvals or conditional approvals. Only approvals issued through the conventional procedure count. The check must therefore run on the procedure type printed in the approval, not merely on the letterhead of the issuing agency, because an otherwise perfect authority choice collapses the moment the approval turns out to be conditional, accelerated or emergency in nature.

Insight 5: the old bilateral equivalence agreements have been superseded. The agreements of 2010-10-26 covering the FDA and Health Canada, and of 2012-01-25 covering Japan, were uniformly replaced by the new guidelines published in DOF 2025-07-18, and from 2025-10-06 applications are no longer received under the old codes. Any dossier template that still cites the 2010 or 2012 agreements is obsolete and must not be filed.

4. Practical recommendations

• Build a reference approval verification sheet with four fields: the authority, the procedure type, the issue date, and the product scope, and tick each field off one by one before committing to the route.
• If the approval is approaching the 5-year limit, give the abbreviated pathway filing the highest scheduling priority; if the limit has already passed, prepare under the standard pathway instead.
• File the MDSAP certificate separately within the quality system evidence package, kept apart from the product approval documents.
• Where approvals from several countries exist, select the one obtained within the last 5 years that matches the version submitted in Mexico exactly.
• After October 2025, do not cite the old bilateral equivalence agreements as the basis for any application.

5. Verification checklist

• □ The reference regulatory authority is an IMDRF Management Committee member or an MDSAP member
• □ The reference approval was obtained through a conventional procedure
• □ The reference approval was obtained within the last 5 years
• □ The MDSAP certificate has been filed within the quality system evidence package
• □ The 2010 / 2012 former equivalence agreements are not cited

Regulatory information verified as of October 28, 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Mexican market. Our team manages COFEPRIS registrations and equivalence (equivalencia) reviews, coordinates third-party authorised centre routes, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com