Expansion of Mexico’s Regulatory Pathway for Medical Devices

Mexico’s expedited regulatory medical device pathway, known as the Equivalence Route, was previously limited to recognizing marketing authorizations issued by the health authorities of only three countries: the United States, Canada, and Japan. However, on July 18, 2025, Federal Commission for the Protection against Sanitary Risk (COFEPRIS) published a landmark agreement in the Diario Oficial de la Federación, establishing the General Guidelines for the Application of the Abbreviated Regulatory Pathway for Health Supplies, which includes both drugs and medical devices.  

An initial agreement outlining the new expedited pathway was published on June 11, 2025. While it introduced the framework, it lacked specific details regarding which Recognized Regulatory Authorities (RRAs) would be recognized as well as information on the distinct application forms required for each pathway.  These critical elements have now been clarified in the July 18, 2025 publication. The changes will come into effect on September 1, 2025.  

Under the updated guidelines, COFEPRIS will recognize regulatory 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. 

Medical devices approved by the health authorities of the following jurisdictions are now eligible for expedited registration in Mexico: 

• Australia  

• Brazil  

• Canada  

• China  

• European Union  

• Japan  

• Russia  

• Singapore  

• South Korea  

• Switzerland  

• United Kingdom  

• United States 

This initiative marks a major advancement in regulatory convergence and international harmonization. It is designed to streamline access to safe, effective, and high-quality health technologies in Mexico, fostering innovation and improving public health outcomes. 

Submission Requirements Under the Expedited Process

The specific requirements for this expedited pathway are outlined in the newly published agreement. 

A new application form tailored to this expedited process has been introduced. Currently, there are no changes to the registration fees based on the device’s risk classification.   

Legal and Administrative Documentation 

Applicants must submit the following: 

1. Proof of legal status of the registration holder in Mexico. 

2. Proof of payment of applicable fees.  

3. Certificate of Good Manufacturing Practices (GMP) or an equivalent document from the medical device manufacturer.  

4. Certificate of Free Sale or equivalent issued by the recognized RRA. 

5. Official health authorization for the medical device from the recognized RRA. 

6. Letter of representation for the registration holder in Mexico. 

Technical Documentation 

The technical dossier must include: 

1. Draft labeling in Spanish, in accordance with the corresponding Mexican Official Standard;  

2. Instructions for Use (IFU); 

3. Introductory description of the medical device;  

4. Specifications and description of main components, accessories, and formulation;  

5. Summary of the manufacturing process; 

6. Conformity assessment submitted to the Authority of Recognition, according to the nature and characteristics of the medical device, to ensure its functionality and performance (summaries of processes and tests).  

7. Description of primary and secondary packaging materials;  

8. Clinical evaluation;  

9. Risk analysis;  

10. Certificate of analysis or finished product certificate, and  

11. Technovigilance report.  

It is essential that all technical documentation aligns with the standards and requirements established by the International Medical Device Regulators Forum (IMDRF) and other applicable harmonized international standards relevant to the device type. 

Strategic Implications 

This regulatory reform is expected to: 

• Reduce approval timelines for critical health products (30 days for medical devices) 

• Facilitate market entry for internationally approved technologies 

• Enhance public health outcomes by accelerating access to innovative therapies 

• Strengthen international collaboration in regulatory science and oversight 

Important for ongoing marketing registration applications: 

If the expedited pathway is selected as a regulatory strategy, and a submission has already been filed through the standard process, COFEPRIS will automatically discontinue the ordinary procedure to prevent duplication of efforts. Decisions to do so require a clear regulatory impact assessment regarding the potential impact on timeline to approval involved. 

Overview of Regulatory Pathways 

The following table provides an overview of all available 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 Equivalence(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 (Previously allowed for fast-tracking based on only FDA, EMA, TGA approval) – Faster review (max. 30 working days)- Only minimal documentation required for validation	Devices approved by: IMDRF members and MDSAP participants
3. 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
4. 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
5. Emergency Use Authorization (EUA)	Temporary authorization during public health emergencies.	Limited use scenarios (e.g. pandemics) – Time-limited – Non-transferable	Urgent-use products only

Mexico’s Regulatory Device Pathway

The introduction of Mexico’s abbreviated regulatory pathway represents a significant milestone in the country’s health regulatory framework. By aligning with internationally recognized standards and incorporating trusted foreign regulatory evaluations, Mexico is enhancing the efficiency, transparency, and accessibility of its health system. This strategic shift not only accelerates the availability of medical technologies but also reinforces the country’s commitment to global regulatory harmonization and the advancement of public health. 

How can MedEnvoy Support 

If you have any questions about this summary on Mexico’s regulatory medical device pathway or the accompanying guidance document, or if you require assistance with regulatory reviews, product classification, or compliance planning, our regulatory experts are available to support you. Please feel free to reach out to us here. To learn more about our Mexico Registration Holder services, click here.