Navigating COFEPRIS: A Deep Dive into Mexico's 'Reglamento de Insumos para la Salud' for Medical Devices

Medical Device Global Market Access · Nov 18, 2025 · 3m

This episode provides a detailed overview of Mexico's medical device regulations, focusing on the Reglamento de Insumos para la Salud. We explore the role of the regulatory authority, COFEPRIS, the risk-based device classification system, and the available registration pathways, including the Standard and Equivalency routes. The host also covers the crucial updates from the 5th edition of the Mexican Pharmacopoeia's supplement, which became effective in July 2023. - What is the primary regulation for medical devices in Mexico? - How does COFEPRIS classify medical devices based on risk? - What…