COFEPRIS Simplifies Medical Device Registration Procedures in Mexico

Following our previous updates on “COFEPRIS Streamlines Medical Device Registration: Key Takeaways from Articles 22 to 25 of the Official Gazette” (July 7) and “Mexico COFEPRIS 2025 Abbreviated Pathway for Medical Devices” (August 6), Mexico’s regulatory authority, COFEPRIS, has issued a new update on August 22, 2025. This update aims to further simplify medical device registration in Mexico.  

The new agreement consolidates procedures, introduces new homoclaves for low- and higher-risk devices, and cites legal provisions to reduce bureaucratic steps. These measures are designed to help both domestic and foreign manufacturers achieve faster, more efficient regulatory approvals.

Key Simplification Measures for Medical Devices

1. Elimination of Redundant Documentation

Manufacturers will no longer need to resubmit documents already issued by COFEPRIS, such as permits or certificates. This change reduces unnecessary paperwork and prevents delays caused by duplicate submissions.

2. Introduction of new Homoclaves

Clear homoclaves have been established for different categories of medical devices, distinguishing between low-risk and higher-risk products. This classification enables manufacturers to quickly determine the regulatory requirements for their devices, simplifying the application process.

3. Merging and Debugging of Application Modes and Codes

The agreement addresses the complexity of multiple overlapping application types by merging and clarifying modes and codes. This makes it easier for manufacturers to identify the correct pathway for their devices, whether low-risk consumables or high-risk implantables.

4. Time Reduction for Approvals

Approval timelines have been shortened. Certain sanitary registrations that previously required 30 business days are now set at 20 business days. While practical outcomes depend on implementation, this change signals COFEPRIS’s intent to accelerate the review process, benefiting companies introducing urgent or innovative devices.

Broader Simplification Actions Affecting Devices

In addition to these medical device–specific measures, the agreement introduces broader regulatory improvements:

• Merging multiple procedures for sanitary registration of medical devices, medicines, and biological products.

• Updated and simplified requirements for registrations, permits, and certificates.

• Elimination of certain procedures, particularly those related to equivalence agreements with other countries, that will now be covered by a unified pathway.

• Transitional provisions, with most changes taking effect 30 business days after publication and others requiring up to 180 business days.

• Requirement to accredit legal representation, ensuring procedural clarity.

• Promotion of digital platforms, enabling faster submissions and real-time tracking.

Why This Matters for the Medical Device Industry

For manufacturers—both domestic and foreign—these reforms bring tangible benefits:

• Faster Market Access – Shortened approval timelines enable devices to reach hospitals and patients sooner.

• Lower Compliance Burden – Reducing redundant documentation and steps saves time and costs.

• Simpler Pathways – Merged and clarified application codes minimize errors and confusion.

• Encouraged Innovation – A more efficient regulatory framework fosters confidence to introduce advanced medical technologies.

For patients and healthcare providers, these changes mean earlier access to innovative medical devices, from diagnostic tools to life-saving implants, without compromising safety or quality.

Conclusion

The August 22, 2025 COFEPRIS simplification agreement, effective October 6, 2025, represents a milestone for Mexico’s medical device sector. By eliminating redundant requirements, merging application pathways, and shortening approval timelines, COFEPRIS is creating a more agile and predictable regulatory environment.

If effectively implemented, these reforms could make Mexico a more attractive market for medical device innovation while ensuring that patients benefit from faster access to advanced healthcare technologies.

Internal links:

• Learn more about COFEPRIS Mexico Medical Device Regulation

• Learn more about COFEPRIS Mexico Medical Device Registration

External links:

• COFEPRIS Official Publication – August 22, 2025

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