How medikana supports you

At medikana, we specialize in helping medical device manufacturers from the United States, Canada, and Europe expand into Latin America. Our team assists in navigating regulatory frameworks, identifying qualified distributors, and designing market-entry strategies that ensure a smooth and successful launch.

With COFEPRIS introducing a new Fast-Track Regulatory Pathway, this is an excellent opportunity for global manufacturers to bring their innovations to Mexico faster. medikana can guide you through the process, from assessing eligibility to managing local partnerships and documentation, so you can leverage this new route effectively and accelerate your commercialization timeline.

About the COFEPRIS Fast-Track Pathway

COFEPRIS has announced a new Fast-Track Regulatory Pathway that will transform how medical devices obtain sanitary registration in Mexico. Starting September 1, 2025, products approved by high-standard regulatory agencies will be able to enter the Mexican market through a faster and more streamlined process.

What’s changing?

Devices with ordinary approvals from Reference Regulatory Authorities (RRA) such as the FDA, Health Canada, TGA, or CE under MDR will be eligible to obtain their Mexican registration within 30 business days.

This significantly reduces time-to-market and provides greater predictability for both global manufacturers and local distributors.

Key eligibility requirements

To qualify, a device must:

• Be identical to the version approved by the international authority (specifications, quality, safety, and performance).
  
  
• Hold an ordinary (full) approval, meaning:
  
  
  • The authority conducted a complete safety and efficacy evaluation.
    
    
  • The product went through the standard review process.
    
    
  • There are no pending conditions or temporary authorizations.
    
    
  • It was not accelerated, conditional, or emergency-based.
    
    
  • Examples include: FDA PMA or 510k approval or CE Mark under MDR without special conditions.
    
    
• Present technical documentation aligned with IMDRF standards and COFEPRIS criteria.
  
  

Why this matters for the industry

The fast-track pathway creates an opportunity to:

• Bring innovative technologies to Mexico more efficiently.
  
  
• Reduce regulatory timelines and associated costs.
  
  
• Strengthen competitiveness and accelerate adoption of advanced medical solutions.
  
  

For manufacturers with products already approved by high-standard agencies, this is the perfect moment to plan entry or expansion into the Mexican market with the right local support.