Discover COFEPRIS new regulatory reforms for medical devices in Mexico.

New Medical Device Approval: Regulatory COFEPRIS Reforms

August 28, 2025

5 mins

Home » Resources & News » New Medical Device Approval: Regulatory COFEPRIS Reforms

On August 22, 2025, as part of the new COFEPRIS regulatory reforms, the authority issued a new agreement concerning medical devices and drugs, aimed at streamlining regulatory processes. This initiative includes the consolidation of procedures, shortened timelines, and the elimination of redundant requirements, aligning with the latest updates and strategic pathways proposed by the authority.

COFEPRIS published an initial agreement on June 11, 2025, outlining the new expedited pathway. The July 18, 2025, COFEPRIS publication further clarified critical elements, including which Recognized Regulatory Authorities (RRAs) would be accepted and the distinct application forms required for each pathway. These changes will take effect on September 1, 2025.

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Key Highlights of COFEPRIS Regulatory Reforms

The changes described below will come into effect on October 6, 2025. It should be noted that the projected timelines are subject to change and cannot be confirmed until the agreement is fully enacted.

Merged Procedures:

The consolidated processes are to standardize Homoclaves and reduce timelines:

Sanitary Registration submission	New identification name	Homoclave (COFEPRIS code)	Class	Current Timeline (business days)	New timeline (business days)
For National Manufacturers	Medical Device Sanitary Registration	COFEPRIS-04-060	Class I	30 days	20 days
For Foreign Manufacturers			Class II	35 days	25 days
For contract manufacturers for National Manufacturers			Class III	60 days	35 days
For National LOW-RISK devices Manufacturers	LOW-RISK Medical Device Sanitary Registration	COFEPRIS-04-070	Class I Low Risk	30 days	15 days
For Foreign LOW-RISK devices Manufacturers
For contract manufacturers for National LOW-RISK devices Manufacturers

Renewals and Modifications:

Beyond the standardization of the Homoclave for Renewals and modifications, the agreement outlines specific requirements and introduces a significantly reduce timeline for processing.

Description	New identification name	Homoclave (COFEPRIS code)	Requirements	Current Timeline (business days)	New timeline (business days)
Sanitary Registration Renewal for National Manufacturers	Sanitary Registration Renewal	COFEPRIS-04-090	1. ISO 13485 or equivalent document 2. Letter of Representation for the holder of the registration	120 days	45 days
Sanitary Registration Renewal for Foreign Manufacturers	Sanitary Registration Renewal	COFEPRIS-04-090		120 days	45 days
Medical Device Sanitary Registration Modifications	Medical Device Sanitary Registration Modifications	COFEPRIS-2022-022-004-A	Technical Information Project Label Instructions for Use in Spanish	22 days	11 days

Equivalence Route

Mexico’s expedited regulatory medical device pathway, known as the Equivalence Route, recognizing marketing authorizations issued by the health authorities of the United States, Canada, and Japan countries will now be eliminated according to this agreement by October 6. This is intended to avoid duplicating processes, given the existence of the new abbreviated route (General Guidelines for the Application of the Abbreviated Regulatory Pathway for Health Supplies) Under the updated guidelines, COFEPRIS regulatory reforms will recognize evaluations conducted by members of the International Medical Device Regulators Forum (IMDRF) and participants in the Medical Device Single Audit Program (MDSAP). This recognition enables COFEPRIS to treat these foreign evaluations as equivalent to national assessments, significantly accelerating the approval process for medical devices.

Homoclave (COFEPRIS code)	Process name
COFEPRIS-04-001-D	Sanitary Registration submission for Medical Devices class I with FDA approval (USA and Canada Equivalence Route).
COFEPRIS-04-001-E	Sanitary Registration submission for Medical Devices class II and III with FDA approval (USA and Canada Equivalence Route).
COFEPRIS-04-001-F	Sanitary Registration submission for Medical Devices class II III and IV with Health Canada approval (USA and Canada Equivalence Route).
COFEPRIS-04-001-G	Sanitary Registration submission for Controlled Medical Devices with conformity criteria (Class II) (Japan Equivalence Route).
COFEPRIS-04-001-H	Sanitary Registration submission for Medical Devices Class II (without conformity Criteria), III, IV with approval letter of Japan MHLW (Japan Equivalence Route).

Overview of Regulatory Pathways

The following table provides an overview of all available updated regulatory pathways for medical devices in Mexico.

Pathway	Description	Key Features	Applicable To
1. Standard Registration (Registro Sanitario Ordinario)	Traditional evaluation route requiring full dossier review by COFEPRIS.	Local or foreign products without eligible prior approval – Full technical documentation required – Includes administrative and technical evaluation.	All classes (I, II, III)
2. Abbreviated Regulatory Pathway via (Vía Regulatoria Abreviada)	Updated as of July 2025 – based on recognition of foreign regulatory decisions.	Relies on approvals from recognized Reference Regulatory Authorities (ARRs) or WHO Prequalification. Faster review (max. 30 working days)- Only minimal documentation required for validation.	Devices approved by: IMDRF members and MDSAP participants
3. Low-Risk devices Registration	Low-risk devices.	Applies to low-risk devices that requires registration.	Class I Low-Risk devices
4. Modification or Renewal of Registration	Used for updating device registration or renewing it before expiry.	Requires original registration to be in good standing – Must follow COFEPRIS guidance on changes (e.g., labeling, indications).	All registered devices
5. NOM-241 / Import Authorization Only	For low-risk Class I devices exempt from registration but needing customs clearance.	Applies to low-risk devices in the NOM-241 list- Requires import permit but not full registration.	Class I devices
6. Emergency Use Authorization (EUA)	Temporary authorization during public health emergencies.	Limited use scenarios (e.g. pandemics) – Time-limited – Non-transferable.	Urgent-use products only

What to Expect as a Manufacturer:

The series of regulatory reforms introduced by COFEPRIS throughout 2025 marks a transformative shift in Mexico’s approach to medical devices and drugs oversight. By consolidating procedures, redefining Homoclaves and significantly reducing review timelines, the authority aims to efficiency transparency and alignment with international best practices.

The elimination of the Equivalence route and the emphasis on reliance mechanisms reflect a strategic pivot toward deeper regulatory harmonization and more robust evaluation standards.

While these changes promise to streamline market access and reduce administrative burdens, stakeholders should remain attentive to the evolving implementation landscape.

Close monitoring of COFEPRIS communications will be essential for manufacturers importes and regulatory professionals navigating this new framework.

How MedEnvoy Can Support

MedEnvoy offers expert regulatory support to manufacturers in navigating COFEPRIS requirements. Our expertise ensures that your registration meets the applicable standards, enabling safe ongoing compliance. We encourage you to contact our team for tailored support.