New Regulatory Agreement by COFEPRIS for Simplification of Medical Device Registration Procedures and Shorter Timelines in Mexico:
The Federal Committee for the Protection against Sanitary Risks (COFEPRIS), Mexico, has issued a new regulatory agreement with significant updates for the medical devices industry for simplifying the registration process and shortening the review timelines by COFEPRIS.
Introduction to the COFEPRIS new simplification agreement
On August 22, 2025, Mexico published an agreement “establishing simplification actions for procedures carried out before the Federal Commission for the Protection against Health Risks”. The agreement introduces consolidated registration procedures and a reduction in resolution timelines for streamlining and expediting the approvals of medical devices.
Additionally, it eliminates certain equivalence agreements, which leads to new regulatory strategies, an important update for further registration procedures with Mexico. The agreement aims to reduce the bureaucratic costs and avoid duplication to provide the maximum possible benefit to both the industries and patients.
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Major Implications of the Agreement
2.1 Simplification of the registration procedures
One of the major implications of the agreement for simplification of the registration procedures is the consolidation of certain modalities for registration of medical devices, as follows:
- The application for medical devices manufactured in Mexico, imported medical devices manufactured by a foreign manufacturer, and the products of National Manufacture that are manufactured by another establishment are merged into a common procedure, “Medical Device Health Registry” under the Homoclave COFEPRIS-04-060.
- For low-risk medical devices, the domestically manufactured low-risk devices, imported low-risk devices, and domestically manufactured low-risk devices manufactured by another establishment are consolidated into the “Health Registry of Medical Devices Considered Low Risk” (Homoclave COFEPRIS-04-070).
- Additionally, the applications for the first extension of registration for domestically manufactured and imported medical devices are merged into “Extension of the health registration of medical devices” (Homoclave COFEPRIS-04-090).
Also Read: COFEPRIS Regulations For Medical Device Registration
2.2 Reduction in resolution timelines
- Along with the registration procedure changes, the agreement has also introduced significant reductions in the resolution timelines for medical devices, a crucial step for expediting the medical device approvals in Mexico.
- The resolution time for Class I medical devices has been shortened from 30 business days to 20 business days, for Class II medical devices, from 35 business days to 25 business days, and for Class III medical devices from 60 business days to 35 business days.
- For registration of low-risk medical devices, the resolution timeline has now been reduced from 30 business days to 15 business days. Additionally, the resolution timeline for the extension of registration of medical devices has been significantly reduced from 120 calendar days to 45 calendar days.
Also Read: COFEPRIS Reliance Pathway Agreement
2.3 Elimination of equivalence pathways
- Another major change in the regulatory procedure of Mexico, as per the new agreement, is the elimination of equivalence agreements for the medical devices seeking registration based on prior approvals by certain foreign authorities.
- The applications for medical devices based on the US FDA for Class I, II, and III registrations, based on Health Canada for Class II, III, and IV medical devices registrations, and based on the Japan equivalence agreement (Class II, III, and IV) will no longer be accepted. However, the registrations based on the Reference Regulatory Authorities (RRA) agreement, according to the agreement published in July 2025 by Mexico, will still be considered acceptable.
Major Key Takeaways from the COFEPRIS New Agreement
Simplified registration procedures: The new agreement has consolidated medical devices registration procedures for new medical devices registration, registration of low-risk devices, and first extension applications of medical devices registration under a single procedure, and renamed as Medical Device Health Registry, Health Registry of Medical Devices Considered Low Risk, and Extension of the health registration of medical devices. This led to the simplification of registration procedures for medical devices in Mexico.
- Faster approvals: To speed up the medical device approvals and provide faster access to patients in Mexico, COFEPRIS has shortened the review timelines for medical device applications.
- Shift in the regulatory strategies: The elimination of the equivalence pathways based on previous registrations for faster approvals of medical devices in Mexico marks a major shift for the industry, which may increase the market entry time of the product. Manufacturers must comply with the COFEPRIS requirements and plan their approval based on the RRA reliance pathway for faster approvals.
Conclusion
The COFEPRIS, Mexico, is simplifying the registration procedures for medical devices by transitioning towards accelerating the approval processes and providing faster access to medical devices for patients. With the evolving regulatory landscape of Mexico, manufacturers must adjust their regulatory strategies to comply with the Mexican regulatory requirements.
Artixio provides strategic regulatory support for faster and efficient approvals of medical devices in Mexico and ensures the timely compliance with evolving COFEPRIS regulatory requirements.
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