Mexico strengthens its commitment to simplify access to the Medical Devices market. With the publication of Acuerdo nel Diario Oficial de la Federación on June 11, 2025, COFEPRIS formalised a major expansion of its programme for the recognition of Regulatory Reference Authorities (RRAs). The upgrade not only enhances the already existing equivalence and abbreviated registration route but also marks a new opening to foreign manufacturers, consolidating Mexico’s position as a strategic market and an attractive investment opportunity.

Recognised RRAs and Accepted Certificates: a significant expansion

The Acuerdo (Agreement) formally extends the list of recognised RRAs. From a more selective approach, Mexico now officially accepts approvals from all members of the International Medical Device Regulators Forum (IMDRF) and all authorities participating in the Medical Device Single Audit Programme (MDSAP).

In summary, the recognition concerns the regulatory authorities of the following countries:

  • European Union (via CE marking according to MDR/IVDR)
  • Australia (TGA)
  • Brazil (ANVISA)
  • Canada (Health Canada)
  • China (NMPA)
  • South Korea (MFDS)
  • Japan (PMDA)
  • United States (FDA)
  • United Kingdom (MHRA)
  • Singapore (HSA)
  • Switzerland (Swissmedic)

Consequently, EC Certificates of Conformity, MDSAP Certificates and GMP (Good Manufacturing Practices) certificates issued by these RRAs are now formally accepted as equivalent proof of conformity; this allows for a faster evaluation phase and a shortened registration path.

Full equivalence: the essential condition

To access the shortened pathway, complete equivalence between the device to be entered into Mexico and the one already approved by the relevant RRA is essential. That is, the essential characteristics of the medical device to be registered in Mexico must be identical to those of the MD already authorised by the reference RRA, with regard in particular to the appearance of the medical device, intended use, operating principles and performance. Any deviation may necessitate recourse to the standard registration route. The Acuerdo emphasises that the approval of the RRA must result from an ordinary and comprehensive review, excluding approvals based on accelerated or emergency mechanisms of other jurisdictions.

The abbreviated COFEPRIS pathway: timing and realism

The abbreviated COFEPRIS approach is designed for Medical Devices that have already obtained strict approvals from the RRA. Although theoretically the assessment in the shortened pathway could be concluded in only 30 working days, as desired by COFEPRIS, our experience in the Mexican regulatory landscape, which has recently faced several critical issues – suggests that the actual approval time could be longer. In any case, thanks to the new acuerdo, processes can be optimised and time reduced.

The main objective of this route is to optimise processes by exploiting the concept of ‘reliance‘ (recognition of the decisions of other regulatory agencies), provided that it is based on comprehensive and independent reviews of the reference authorities, while ensuring product safety.

The important thing is to proceed with the right regulatory strategy and with the support of those with experience in the Mexican regulatory environment.

As of July 20, 2025

Just over a month after the June 11th Acuerdo, on July 18, 2025, Cofepris published a new Acuerdo regarding the abbreviated pathway. This new Acuerdo cancels and replaces the previous one while maintaining the substance of its provisions. The new Acuerdo adds clarity and specific details, eliminating any ambiguities.

In particular, the following aspects are now clearer:

  • Accelerated registrations will have the same legal effects and obligations as ordinary registrations.
  • A more explicit list of required documents has been provided, specifying that they must be legalized in the country of origin and translated into Spanish by a certified translator.
  • Registration applications already submitted are not eligible for this new regime.

👉If you want to distribute Medical Devices in Mexico, we are at your side to guide you through the product registration and as your Authorised Local Representative.

With Thema, your Medical Devices are always in order, wherever they go.

SOURCE:
Acuerdo

07/31/2025