The new Mexican labeling standard is mandatory for manufacturers, importers, distributors, and establishments involved in the manufacture, conditioning, and commercialization of medical devices for human use in Mexico. It establishes updated requirements for the health information that must accompany medical devices, while strengthening regulatory expectations regarding labeling, risk management, traceability, and post-market surveillance.
Companies planning to market medical devices in Mexico should assess the impact of NOM-137-SSA1-2025 on product labeling, regulatory compliance, and market access strategies to ensure timely implementation and continued compliance with COFEPRIS requirements.