NOM-137-SSA1-2025: New labeling framework for medical devices

On May 19, 2026, the Ministry of Health, through the Comisión Federal para la Protección against Riesgos Sanitarios ( "COFEPRIS“), published in the Official Gazette of the Federation (“DOF") the "Official Mexican Standard NOM-137-SSA1-2025, Labeling of Medical Devices"(From"NOM-137-2025“), which updates and clarifies the health information requirements that must be included on the labels of medical devices for human use intended for sale or distribution within the national territory. NOM-137-2025 repeals NOM-137-SSA1-2008Published on December 12, 2008, it establishes more precise controls and procedures to ensure the safe and effective use of these supplies by users, health professionals and the general population.

KEY POINTS OF NOM-137-2025

Object and Scope of Application

NOM-137-2025 establishes the health information requirements for the labeling of medical devices for human use, including information on their proper use and traceability. Compliance is mandatory throughout Mexico for establishments that manufacture, package, distribute, or import medical devices for sale or supply in Mexico. The term "medical device" encompasses a wide range of products, from medical equipment, prostheses, orthoses, and assistive devices to diagnostic agents, surgical materials, dental supplies, hygiene products, and software used for medical purposes (ScDM).

General Labeling Requirements

All health information must be expressed in Spanish, using legible font and size, and in terms understandable to the user. Labeling may be supplemented electronically using RFID, QR codes, or other digital platforms, provided that such information does not replace or contradict the information authorized in the Sanitary Registration. Labeling elements must be developed and evaluated based on risk management and must be subject to version control by the holder or manufacturer. When the original label does not contain the information required by the NOM—as is often the case with imported devices—the supplementary information may be added via a counter-label after customs clearance and prior to marketing or distribution.

Mandatory Identification and Traceability Information

The labeling of all medical devices must include the following identification elements:

• Generic name and distinctive name (name or trademark) of the medical device.
• Health registration number granted by COFEPRIS.
• Expiry date y Manufacturing date.
• Batch or serial number, anywhere on the primary, secondary, multiple or collective packaging.
• Catalog number, model, code or version to distinguish the device from other similar ones.
• Content of the medical device, indicating number of units, pieces, dimensions or volume, as applicable.
• Identification of the manufacturer, legal manufacturer, importer and/or distributor, with full company name and address.

Warnings, Precautions and Instructions for Use

The labeling must include all warnings and precautions that must be communicated to the user, including those relating to latex materials, potentially infectious substances, sterile devices, single-use devices, and devices with radiation sources. The instructions for use must provide, among other things, procedures for preparation, installation, maintenance, disinfection, and disposal, as well as the information necessary to identify any adverse incident and the competent authority to contact in such an event. Residual risks identified through risk management must be incorporated into the instructions for use or any other element of the labeling.

Specific Requirements by Device Type

NOM-137-2025 includes additional rules for the following cases:

• Devices with size limitations: They must contain at least the batch number, generic and distinctive name, contents and expiry date on the primary packaging; the rest of the health information must appear on another element of the labeling.
• Software as a Medical Device (ScDM): It must be identified with a unique identifier (version, revision level, or release date), and its labeling may be available in an electronic format accessible from the software itself.
• Devices for use by the general population: Instructions for use should be written in easily understandable terms and may be supplemented with drawings or diagrams.
• Kits (Game/Package): They must identify all their components, declare the sanitary registration number of the kit and of each component input, and indicate the expiration date of the input with the shortest period.
• In vitro diagnostic (IVD) agents: They require information on the type and principles of the test, characteristics of the analytical and clinical performance, conditions for collecting and handling samples, and specific signage for exclusive use in laboratories when applicable.

Conformity Assessment and Surveillance

The enforcement of NOM-137-2025 is the responsibility of the Ministry of Health, through COFEPRIS, whose personnel will conduct the necessary verifications. Conformity assessment will be carried out through verifications at the distributor's manufacturing sites and warehouses, as well as during the evaluation of applications for Sanitary Registration and their modifications.

KEY DEADLINES

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For more information on the requirements applicable to the marketing, import and registration of medical devices in Mexico, and compliance with NOM-137-SSA1-2025, please contact us.