Mexico COFEPRIS Equivalence Pathway: New Guidance for Medical Device Registration

Medical Device Global Market Access · Aug 5, 2026 · 5m

Mexico's COFEPRIS released new guidance in late July 2026 clarifying documentation requirements for its Equivalence and Abbreviated regulatory pathways. This episode provides a practical breakdown of the key changes affecting medical device and IVD manufacturers. We discuss the updated specifications for critical documents like the Certificate of Free Sale and Letter of Equivalence, who is impacted by these immediate changes, and actionable steps your regulatory team can take to ensure your submission dossiers are compliant and can avoid unnecessary delays. Key Questions: - What are the…