Mexico COFEPRIS 2025 Abbreviated Pathway for Medical Devices

Following our previous update on “COFEPRIS Streamlines Medical Device Registration: Key Takeaways from Articles 22 to 25 of the Official Gazette” published on July 7, Mexico’s regulatory authority COFEPRIS has released further guidance via the General Guidelines for the Application of the Abbreviated Regulatory Pathway.

This Abbreviated Pathway or the new equivalency route, effective September 1, 2025, further simplifies the medical device registration process by recognizing prior foreign approvals, reducing documentation redundancy, and enforcing a clear 30-day decision timeline. It directly builds on the June 2025 reforms and significantly enhances predictability, efficiency, and alignment with global regulatory standards.

What Is the Abbreviated Pathway?

The Abbreviated Regulatory Pathway is a fast-track approval mechanism that allows COFEPRIS to recognize prior evaluations from foreign regulatory authorities. For medical devices, this includes agencies that are:

• Members of the International Medical Device Regulators Forum (IMDRF)

• Participants in the Medical Device Single Audit Program (MDSAP)

To qualify, the device submitted must be identical to the one previously approved in another market—this includes the design, components, formulation, intended use, and manufacturing process.

How to Apply for Medical Devices

Applications for medical devices must follow this process:

• Procedure Code: COFEPRIS-04-050

• COFEPRIS will issue its decision within 30 business days of receiving a complete application.

This significantly shortens the review period compared to the traditional route.

Required Documents for Medical Devices

I. Administrative-Legal Documents:

• Spanish-language product label

• User manual or instructions, if applicable

• GMP certificate or equivalent

• Certificate of Free Sale

• Marketing authorization from the reference authority

• Letter of representation for the Mexican applicant

II. Technical Documentation:

• Introductory description of the device

• Details on components, accessories, and formulation

• Manufacturing process summary

• Performance and conformity testing results

• Details of primary and secondary packaging

• Clinical evaluation

• Risk analysis report

• Analytical or finished product certificate

• Technovigilance report

When Does It Take Effect?

This abbreviated pathway becomes valid on September 1, 2025, 30 business days after publication of the guidelines.

Why It Matters for Manufacturers

This new mechanism enhances regulatory alignment with global practices while offering manufacturers a faster, more efficient path into Mexico’s healthcare market.

Benefits include:

• Reduced time to market

• Less duplication of regulatory reviews

• Greater harmonization with IMDRF and MDSAP standards

Learn More

• Visit our Mexico medical device registration page for step-by-step guidance

• Review device classification details on our Mexico medical device classification page

Resources

• Official COFEPRIS Guidelines (Published in the Diario Oficial de la Federación – July 18, 2025)

Mexico’s COFEPRIS 2025 abbreviated pathway lets manufacturers register medical devices based on foreign approvals (FDA, IMDRF, MDSAP). Devices must match the approved version exactly and follow the COFEPRIS-04-050 procedure. Key documents include GMP and Free Sale certificates, risk analysis, and clinical evaluation. Decisions are issued within 30 days.

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