COFEPRIS’ New Abbreviated Regulatory Pathway: Transforming the Registration of Medicines and Medical Devices in Mexico

On July 18, 2025, COFEPRIS published an agreement that promises to significantly speed up processing times for health registration applications for medicines and medical devices in Mexico. This new Abbreviated Regulatory Pathway will come into effect on September 1, 2025, and represents a significant change in the way health products are approved in the country.

What is the abbreviated regulatory pathway?

This new modality allows pharmaceutical and medical device companies to obtain health registrations in Mexico based on prior approvals from internationally recognized Reference Regulatory Authorities (RRAs). This means that products already approved by these agencies can access the Mexican market more quickly and efficiently.

Recognized regulatory authorities of reference

For medications

• Founding members of ICH or permanent regulatory members: ICH Official web site : ICH
• Authorities included in the World Health Organization’s WLA list (with registration and marketing authorization functions): list_of_wla_may24.pd
• This includes agencies such as the FDA (United States), EMA (European Union), TPD (Canada), and Swissmedic (Switzerland), among others.

For medical devices

• Member countries of the IMDRF Management Committee: https://www.imdrf.org/about/management-committee
• MDSAP member regulatory authorities for good manufacturing practice certificates: Medical Device Single Audit Program (MDSAP) | FDA

Key benefits of the new route

Faster resolution times:

• Medicines: 45 business days
• Medical devices: 30 business days
• These deadlines represent a significant reduction compared to traditional health registration processes.

Internationally standardized requirements

For medicines, the dossier must be submitted in CTD format in accordance with ICH guidelines, which facilitates compliance for companies already operating in international markets.

In the case of medical devices, the content and quality of the documentation must comply with IMDRF guidelines, applicable international standards, and COFEPRIS evaluation criteria.

Product equality criterion

The products must have basic characteristics identical to those authorized by the ARR, demonstrating equality in:

• Product features
• Quality study results
• Safety and efficacy or performance

Limitations on types of approval

It is essential to note that only ordinary approvals are accepted, meaning that the following cannot be considered for this route:

• Reliance
• Recognition
• Accelerated approvals
• Conditional approvals
• Emergency authorizations
• Court-ordered approvals
• Any modality other than ordinary approval

Validity of the authorization

In the case of medicines, the marketing authorization issued by an ARR must have been issued within a period of no more than 5 years, ensuring that the regulatory information is up to date.

Documentary requirements

For medications

Module 1. You must submit the following documentation, applicable to the type of application and in accordance with the classification of the medicine:

a. Document proving legal status or RUPA.

b. Proof of payment of fees.

c. Full and reduced IPP.

d. Label and instruction leaflet designs, if applicable.

e. Title, license, or sublicense for exploitation of the patent.

f. For foreign owners: License, certificate, or equivalent document certifying that the company has permission to manufacture medicines, issued by the competent authority of the country of origin.

For holders of the national health registration: must have a health license for a drug factory or laboratory.

g. CBPF or equivalent document for the manufacturer of the drug, biopharmaceutical, antigen, and chemically synthesized drug, issued by an ARN, in accordance with current regulations.

h. CLV or equivalent issued by the Health Authority of Origin with which equivalence is requested

i. Letter of representation from the manufacturer for non-affiliated laboratories

j. For biological and biotechnological (BT) products, the number or folio of the intensive pharmacovigilance program application must be indicated, in accordance with the applicable provisions.

k. Depending on the Authority with which equivalence is requested, the following must be submitted:

1. European Medicines Agency (EMA): Marketing Authorization.

2. Swiss Agency for Therapeutic Products (Swissmedic): Marketing Authorization.

3. United States Food and Drug Administration (FDA): Letter of Approval, Pharmaceutical Product Certificate, and Registered Drug Establishment Document or equivalent.

4. Health Canada – Therapeutic Products Directorate (TPD): Notice of Compliance, Pharmaceutical Product Certificate, and Establishment License Number.

5. Other Reference Regulatory Authorities: Marketing Authorization or equivalent.

For medical devices

I. Administrative and legal information:

1. Document certifying legal status or Single Registry of Accredited Persons (RUPA);
2. Proof of payment of fees
3. Label design in Spanish
4. Instructions or user manual, if applicable, for marketing in Mexico
5. Certificate of good manufacturing practices from the medical device manufacturer or equivalent document
6. Certificate of Free Sale or equivalent issued by the health agency with which equivalence is being sought
7. Health authorization for the medical device issued through the applicable procedure by the health agency of the country with which recognition is being sought
8. Letter of representation

II. Technical information:

1. Introductory descriptive information about the medical device
2. Description and specification of the main components, accessories, and formulation
3. Summary of the manufacturing process
4. Conformity assessment submitted to the ARR, in accordance with the nature and characteristics of the medical device, to ensure its functionality and performance (summaries of processes and tests)
5. Description of primary and secondary packaging materials
6. Clinical evaluation
7. Risk analysis
8. Analytical certificate or finished product certificate
9. Reporte de tecnovigilancia.

This new regulatory pathway represents an unprecedented opportunity to:

1. Accelerate access to innovative medicines and medical devices for Mexican patients.
2. Reduce costs and time for companies in the healthcare sector.
3. Align Mexico with international best regulatory practices.
4. Promote competition and potentially reduce prices for consumers.

Next steps

COFEPRIS is currently preparing to publish the specific format for submitting applications through this new channel. Interested companies should begin preparing their documentation in accordance with the established requirements so that they are ready when the system becomes operational.

Getting ready for change

The successful implementation of this new regulatory pathway requires healthcare companies to adapt quickly to the new requirements and take advantage of the opportunities presented by this modernized regulatory framework.

Does your company need to focus on innovation and regulatory compliance in the pharmaceutical and medical device sector?

Learn about the specialized solutions ANCE offers for the pharmaceutical and medical device industries, designed to help you successfully navigate these new regulatory frameworks and accelerate your entry into the Mexican market.

Contact us:

📧 horacio.buitron@ance.org.mx
📱 +52 56 2552 3562