ARTICLE SUMMARY:
Each month in Global Spotlight we provide market access facts from the country highlighted on the cover of Market Pathways' print issue. The November/December 2025 cover features the Legislative Palace of San Lázaro in Mexico City, where Mexico's Congress meets.
Regulation
Authority: Federal Commission for the Protection against Health Risks (COFEPRIS)
Key Leader: Armida Zúñiga Estrada, PhD, Federal Commissioner, COFEPRIS
Points of Interest
- COFEPRIS offers two authorization routes:
- Standard, requiring the full suite of technical documents, and
- Equivalency, relying on authorization from one of 10 national authorities that sit on the IMDRF Management Committee to streamline review.
- The agency recently expanded the scope of the Equivalency route and committed to quicker reviews overall.
Market Access
Authority: Laboratorios de Biológicos y Reactivos de México SA de CV (BIRMEX)
Key Leader: Carlos Alberto Ulloa Pérez, Managing Director, BIRME
Points of Interest
- BIRMEX is a state-owned firm that runs biennial, centralized procurement of devices.
- Starting in 2026 (for 2027 and 2028 supplies), companies with facilities in Mexico will be prioritized in procurement decisions.
- Procured devices are free to patients via the public healthcare system, covering most of the population.
More Resources
- Market Pathways detailed COFEPRIS’ commitments to expand global reliance and speed review times and warnings from at least one local regulatory expert that companies shouldn’t expect the enhanced performance to last.
- Veraque Consulting Service’s “Ultimate Guide for Regulatory Affairs in Mexico” offers an comprehensive outline of the country’s regulatory framework, procedures, and expected timelines.
