Mexico’s Abbreviated Regulatory Pathway is a Game-Changer for Medical Device Market Access

Watch the video below for an overview of this article on Mexico's new Abbreviated Route for medical devices:

From September 1, 2025, COFEPRIS will activate its Abbreviated Regulatory Pathway, a bold framework designed to reduce approval times, harmonize with global standards, and accelerate patient access to medicines and medical devices. The new pathway allows manufacturers to leverage prior authorizations from trusted regulators such as FDA, EMA (CE), Health Canada, Swissmedic, ANVISA, TGA, MFDS, and NMPA, as well as other ICH, WHO, IMDRF, and MDSAP-recognized bodies to dramatically expedite COFEPRIS evaluations.

This initiative sends a clear message: Mexico is embracing regulatory convergence and collaboration with trusted international health authorities.  

What does Mexico’s new Abbreviated Pathway mean for the medical device industry?

The Abbreviated Pathway brings three main advantages for Mexico and foreign Manufacturers placing devices on the Mexico market:

Regulatory Efficiency
Historically, COFEPRIS registration meant duplicating regulatory processes, even for manufacturers with active authorizations in other major markets. With the acceptance of trusted international regulators, COFEPRIS allows repetitive evaluations to be cut down, making registrations more efficient and reducing administrative burden.  

Global Consistency & Alignment
In the past, Mexico provided Abbreviated Pathways solely for medical devices approved by Health Canada, FDA and PMDA. By significantly broadening the list of accepted international regulators, Mexico has aligned its framework with international regulatory best practices. This allows foreign Manufacturers to uphold their regulatory portfolio and technical documentation with global standards.  

Expedited Access
Decisions under the previous abbreviated pathway (known as the ‘equivalence route’) could take 3 to 6 months. Under the new Abbreviated Pathway, COFEPRIS has introduced a target review timeline of just 30 business days. We are yet to see how this will work in practice. If consistently upheld, this will represent a fundamental shift in how quickly patients, hospitals, and healthcare providers gain access to safe, effective, and innovative foreign medical devices. Shorter timelines mean your medical device can reach local patients and healthcare providers sooner. Consequently, enabling faster access to innovative, effective, safe and life-saving medical devices in Mexico.

How will Mexico’s new Abbreviated Regulatory Pathway work?

For medical devices, the applicable procedure is COFEPRIS-04-050. To qualify, the Manufacturer must ensure that the device remains identical to the one already approved by the reference authority: same formulation, manufacturing process, indications, and technical specifications.  

Foreign Manufacturers are required to provide the technical documentation of the medical device they wish to place on the Mexico market. This includes:

• Device description

• Details on components, accessories, and formulation

• Manufacturing process summary

• Primary and secondary device packaging  

• Label(s) translated into Spanish  

• Instructions for Use/User Manuals translated into Spanish

• Performance and conformity testing results

• Clinical evaluation

• Risk analysis

• Analytical certificate

• Post-market surveillance

• Technovigilance report(s)

As applicable, they will be required to provide the following administrative documents:

• Certificate of Good Manufacturing Practices (GMP) or equivalent

• Certificate of Free Sale  

• Market authorization from the reference authority

• Letter of representation for the Mexican applicant

Manufacturers must ensure all documentation is ready for submission. This means keeping existing technical documentation up to date, translating required documents, and requesting any applicable Certificate(s) to Foreign Government and Certificate(s) of Free Sale within a timely manner.

Mexico’s Abbreviated Pathway represents more than faster approvals

If used effectively, Mexico’s new Abbreviated Pathway could make the country a priority launch market instead of a secondary one, particularly for high-value and advanced medical devices. By recognizing additional trusted regulators, COFEPRIS aims to streamline approvals, reduce delays, and ensure faster patient access to safe medical devices.

COFEPRIS’ Abbreviated Regulatory Pathway is not just a procedural update; it’s a strategic regulatory evolution. For companies aiming to expand in Latin America, this could be the difference between a slow rollout and an accelerated, competitive market entry.

Learn more about COFEPRIS Mexico Medical Device Registration.

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