The Mexican government, through the Ministry of Health and the Federal Commission for the Protection against Sanitary Risks (COFEPRIS), has issued a new agreement that marks a significant shift for international companies seeking to introduce medicines and medical devices into the country.
Effective 30 business days after its publication in the Diario Oficial de la Federación on July 18, 2025, marketing authorizations may be granted within:
- 30 business days for medical devices, and
- 45 business days for medicines,
provided they originate from recognized regulatory authorities.
What does this mean for international companies?
The new framework establishes an abbreviated regulatory pathway based on the principle of regulatory reliance, whereby COFEPRIS adopts assessments conducted by reference health authorities such as:
- U.S. FDA
- European Medicines Agency (EMA)
- Swissmedic
- Health Canada
- Therapeutic Goods Administration (TGA, Australia)
- WHO Prequalification Programme
Key Benefits:
- Significant reduction in approval timelines (from years to weeks)
- No duplication of technical assessments already validated by trusted agencies
- Automatic recognition of authorizations issued by high-surveillance regulatory bodies
- Streamlined process with no additional requirements or prior COFEPRIS-issued documentation
Eligible Products:
- Medicines: generics, innovative biotechnological products, biosimilars, biologicals, and vaccines
- Medical Devices: of any risk class, provided they originate from countries participating in the IMDRF or MDSAP
Core Requirements for Submission:
- Technical dossier in CTD format, aligned with ICH guidelines
- Valid marketing authorization from a recognized reference authority
- Good Manufacturing Practice (GMP) certificates
- Certificate of Free Sale, technical documentation, and labeling compliant with Mexican NOMs
- For medical devices: evidence of compliance with IMDRF guidelines
Important: Only authorizations granted through standard procedures are eligible. Emergency use authorizations, accelerated, or conditional approvals are not valid under this pathway.
Strategic Implications for Market Entry
This reform positions Mexico as a more accessible and attractive destination for global medical innovation. Companies with existing approvals in the U.S., Canada, Europe, or other recognized jurisdictions can bypass redundant evaluations, reducing regulatory risk, operational costs, and time to market.
Additionally, the new agreement repeals all previous related provisions, unifying criteria and eliminating inconsistencies that previously caused uncertainty or procedural delays.
The release of these guidelines marks a pivotal moment in Mexico’s regulatory policy, aligning the country with international standards of efficiency and quality. For global companies, it presents a unique strategic opportunity to expand into one of Latin America’s largest and most influential healthcare markets.
If your company holds regulatory approvals from the U.S., Europe, Switzerland, Canada, Australia, or other recognized reference authorities, now is the ideal time to initiate or accelerate your entry into the Mexican market.
Need support or want to learn more? Get in touch with us at infomarketing@clarkemodet.com. We’re here to help.