NOM-137-SSA1-2025: Updated Labelling Standard for Medical Devices
NOM-137-SSA1-2025 replaces NOM-137-SSA1-2008 as Mexico's primary labelling standard for medical devices. The updated standard revises minimum label content requirements, Spanish-language IFU obligations, and the conditions under which importers and distributors may add a complementary label rather than relabelling the device.
📅 Effective / published: 2025
Manufacturers and importers placing medical devices on the Mexican market should review all existing labels and IFUs against NOM-137-SSA1-2025. Pay particular attention to mandatory Spanish-language content, prominence requirements, and distributor labelling conditions. Devices entering the COFEPRIS registration pipeline from 2025 onwards must comply with the updated standard. Verify current transitional arrangements directly with COFEPRIS for devices already registered under the 2008 standard.
View official source (Diario Oficial de la Federación) ↗