Publication of NOM-137-SSA1-2025, Labeling of Medical Devices

May 25, 2026

Through this announcement, we would like to give notice that the Official Mexican Standard NOM-137-SSA1-2025, Labeling of Medical Devices, issued by the Secretary of Health through the Federal Commission for the Protection against Health Risks (COFEPRIS), was published today, May 19, 2026, in the Official Gazette of the Federation (DOF).

This new standard repeals and replaces NOM-137-SSA1-2008, Labeling of Medical Devices (published on December 12, 2008) in order to bring the national regulatory framework for medical device labeling up to date and align it with current international standards, including the guidelines of the International Medical Device Regulators Forum (IMDRF). Below is a summary of the most relevant points of this new regulation.

1. Purpose and Scope

The objective of NOM-137-SSA1-2025 is to establish requirements for the health information that must be included on the labeling of medical devices intended for human use, thus ensuring their correct identification, proper use, and traceability.

Compliance is mandatory nationwide for operators engaged in the manufacturing, packaging, distribution, or importation of medical devices intended for commercialization or distribution in Mexico.

2. General Labeling Requirements

All health information appearing on labels and back labels must be expressed in Spanish with comprehensible language, with a typography and font size that is legible for the user. The most important general requirements are:

• Health information may be electronically supplemented with radio-frequency identification (RFID), QR codes, websites, or other electronic platforms, none of which may replace or contradict the authorized information of the health registration.
• Labeling must be developed and evaluated with basis in risk management.
• Labels and back labels must be subject to document control (version control) by the holder of the health registration or the manufacturer.
• When the original label does not contain all of the required health information, the supplementary or missing information must be clearly and legibly placed on a visible location of the back label without covering relevant information.
• For imported medical devices, the back label may be affixed within the country after customs clearance and prior to commercialization or distribution to the public.
• Symbols used on the labeling must correspond to the Regulatory Appendix A of the NOM, which contains a catalog of 70 standardized symbols, including categories for: the manufacturer, sterility, storage, safe use, in vitro diagnostic agents, transfusion/infusion, and patient data, among others.

3. Minimum information required on the labeling

The labeling of medical devices must include, at a minimum, the following identification information:

• Generic name of the medical device (as accepted by the COFEPRIS).
• Brand name (trademark or trade name).
• Health registration number issued by the COFEPRIS.
• Expiration date, expressing the year and month (and the day when the nature of the device requires it), using the following terms: “Expiration¨, “Expiry date”, “Use by” (or their abbreviations), or the corresponding regulatory symbol.
• Date of manufacture, which may be included in the lot or serial number provided it is clearly identifiable.
• Lot number or serial number.
• The catalog, reference, model, code, or version number.
• Contents of the device (units, dimensions, volume, weight, and number of tests or applications, as applicable).
• Identification of the manufacturer, packager, importer, or distributor, including the company name and complete address (street, number, district, city, state, ZIP code, and country).
• Country of origin of the medical device.
• Applicable warning, precaution, and safety labels (e.g., sterile device, single-use, contains latex, radioactive material, hazardous substances, etc.).
• Usage instructions with guidelines for the proper use, maintenance, storage, and final disposal of the device, along with user guidance regarding whom to contact in case of an adverse event, including the competent authority.

4. Identification of the manufacturer and importer

The standard specifies which labels should be used to identify the manufacturer or importer, as applicable:

• Devices manufactured in Mexico: “Manufactured in Mexico by:”, “Packaged by:”, “Manufactured for:”, or “Distributed by:”, followed by the company name and complete address.
• Imported medical devices: “Manufactured by:”, “Imported by:”, “Packaged by:”, “Distributed by:”, or the combination “Imported and Distributed by:”, with the company name and full address.
• It is important not to confuse the term “manufacturer,” as approved in the health registration, with “country of origin,” which may be different.

5. Specific requirements by device type

The NOM includes additional requirements for specific categories of medical devices:

• Devices for public health institutions: must include the legend “Not for sale” or “Property of the Health Sector.”
• Radiopharmaceuticals: must indicate the expiration date and time.
• Kits: health registration number of the kit, list of components, and expiration date of the component with the shortest shelf life.
• Formulated devices: must state the qualitative formula or active ingredients.
• Devices incorporating drugs, cells, or tissues of human or animal origin, or blood derivatives: must expressly indicate this.
• In vitro diagnostic (IVD) agents: additional specific requirements regarding analytical and clinical performance, quality control procedures, self-tests, calibrators, and sample handling.
• Software as a Medical Device (ScDM): must be identified with a version number or revision level; labeling may be available electronically, accessible from the software itself or via a URL.
• Devices for the general public: instructions written in easily understandable terms, which may be supplemented with drawings and diagrams.
• Devices with size or design limitations: the primary packaging must display, at a minimum: batch number, generic name, brand name, contents, and expiration date.

6. Conformity Assessment and Monitoring

Compliance monitoring corresponds to the Secretary of Health through the COFEPRIS, which can be carried out via inspections at:

• Manufacturing sites and the manufacturer’s or distributor’s warehouses, as authorized by the Health Registration Certificate.
• Evaluating applications for health registrations or applications to amend these, based on the submitted health labels.

7. Validity and Transitory Provisions

• NOM-137-SSA1-2025 will enter into force 360 calendar days after its publication in the Official Gazette of the Federation (approximately May 14, 2027).
• Upon entry into force, NOM-137-SSA1-2008 will be repealed.
• Operators who cannot immediately modify the labeling on their medical devices will have an additional period of 180 calendar days following the NOM’s entry into force to deplete their inventory of packaging materials and finished products that bear the previous labeling.

The Regulatory Team at Arochi & Lindner is at your service to address any questions or comments and provide an impact analysis as a result of the publication and implementation of the NOM, whether with regard to reviewing and adapting labels or back labels, conducting applicable risk management assessments, or any required procedure with the COFEPRIS. Please don´t hesitate to contact us.