Mexico Medical Device Labeling

On May 19, 2026, the Mexican Health regulator (COFEPRIS) published NOM-137-SSA1-2025, replacing NOM-137-SSA1-2008. The new standard updates medical device labeling requirements, including provisions covering labeling, traceability, and risk communication. It takes effect May 14, 2027, with an additional 180 days (until November 10, 2027) to deplete existing inventories of devices whose labeling cannot be modified to meet the new requirements.

The NOM 137 standard ties labeling to traceability, risk management, and techno-vigilance, and adds requirements for electronic labeling, SaMD, and standardization labeling symbols. U.S. manufacturers and exporters should review their labeling and packaging requirements with Mexican importers ahead of the effective date. Manufacturers registering devices in Mexico should view this as a significant compliance update rather than a minor administrative change.

The full regulation is available in the Mexican Official Gazette. 

For further questions, please reach out to: Sylvia Montaño: sylvia.montano@trade.gov