How Classification Works
Mexico's medical device risk classification system under the Reglamento de Insumos para la Salud — Class I, II, and III, and the 2025 Annex framework.
Class I · II · III — Overview
Detailed overview of Mexico's three medical device risk classes, their characteristics, and the regulatory requirements that apply to each.
Low-Risk Devices — Annexes 1, 2 & 3
The July 2025 COFEPRIS classification decree and its three-Annex system that replaces prior exemption agreements for low-risk medical devices.
IVD Classification
Classification rules for in vitro diagnostic (IVD) devices in Mexico under the Reglamento de Insumos para la Salud and COFEPRIS guidance.
Software & SaMD Classification
How COFEPRIS classifies software as a medical device (SaMD), including mobile health apps, AI/ML tools, and IVD software, and when software falls outside device regulation.