NOM-137-SSA1-2025: Mexico’s New Labeling Standard for Medical Devices

Mexico now requires strict label matching for medical devices. NOM-137-SSA1-2025 replaced the 2008 standard and was published on May 19, 2026. Its rules cover all printed information on packaging. The law says manufacturers must include specific health details on labels before devices can reach Mexican users. Companies must ensure labels match the exact wording already approved in COFEPRIS registration record.

This article covers what NOM-137-SSA1-2025 actually says, including key labeling obligations, applicability and the link to COFEPRIS registration.

What Is NOM-137-SSA1-2025?

NOM-137-SSA1-2025 is now the legally binding labeling rule for medical devices in Mexico. It mandates that every piece of health-related information on labels and accompanying documents must be precise and fully compliant. It was signed on March 11, 2026, and officially published in the Official Gazette (DOF) on May 19, 2026, marking the start of a strict compliance clock. The standard doesn’t take effect immediately. It becomes enforceable exactly 360 calendar days later, around mid-May 2027. This creates distinct preparation and compliance deadlines for manufacturers.

Quick facts

• Official title, NOM-137-SSA1-2025, Etiquetado de dispositivos médicos, issued by the Secretaría de Salud through COFEPRIS.
• Signed in Mexico City on March 11, 2026, then published in the DOF two months later, on May 19.
• Fully replaces NOM-137-SSA1-2008 once it takes effect as per Transitorio Primero
• Applies to manufacturers, packagers (“acondicionadores”), distributors and importers of medical devices commercialized or supplied in Mexico.

Its objective is to set the health information requirements for labeling, correct use, and traceability of medical devices for human use marketed or supplied in Mexican territory. Medical equipment, prostheses, orthoses, functional aids, diagnostic agents (in vitro diagnostics included), dental supplies, surgical and healing materials, hygiene products. Foreign or domestic, all of it falls under this scope.

What Changed Under NOM-137-SSA1-2025?

The DOF preamble explains why the standard was updated. The 2008 version had been included in Mexico’s National Quality Infrastructure Program for several years running, flagged for revision, specifically so its minimum labeling rules could get more precise.

A direct comparison of the 2008 and 2025 official texts confirms the following changes:

The removal of the numeric expiration-date cap is notable for products whose stability data supports a longer shelf life than the old 5-year ceiling allowed.

And the disappearance of a standalone “a granel” category means bulk, variable-content devices should be checked against the general size/design provision in Section 6.2 rather than assumed to fall under a dedicated bulk-labeling rule.

What Must Appear on a Medical Device Label

Manufacturers should review their complete label, counter-label, and packaging artwork against Chapter 5 (General Requirements) and Chapter 6 (Specific Requirements) of NOM-137-SSA1-2025 before placing a device on the Mexican market, because the standard lists specific data points rather than general principles.

The core Mexico Medical Device Labeling Requirements include, where applicable to the specific device:

• Generic name accepted by COFEPRIS, and brand name, the only element allowed to appear in a language other than Spanish.
• The Registro Sanitario number issued by COFEPRIS
• Expiration date, tied to the manufacturer’s stability studies, expressed at minimum as year and month
• Manufacturing date, which may be embedded in the lot or serial number if clearly identifiable
• Lot or serial number, catalog or model number, and net content or quantity.
• Warnings, precautions, sterility status, single-use or reusable status, and where relevant, radiation, latex, biological material, or hazardous-substance declarations.
• Intended use, declared by the manufacturer or Titular del Registro Sanitario.

Not every item applies to every device.The standard scales requirements to a device’s nature and risk profile, and small devices that can’t carry a full label follow a separate rule. Required information must appear on the primary, secondary or collective packaging, or in the instructions for use. And electronic content via website, QR code, barcode or RFID may complement the physical label but never replace it.

There’s also a practical difference in where information can legally sit. NOM-137-SSA1-2025 breaks this into five layers.

• The device itself, direct marking, where size and design allow.
• The primary package, the material in direct contact with the device.
• The secondary package, the outer commercial packaging.
• The multiple/collective package, any outer container holding two or more primary or secondary packages.
• The instructions for use (IFU) or manual, carrying more detailed technical or safety information.

Some data points, like the generic name, lot number, model number and expiration date, generally need to travel with the smallest saleable unit. More detailed technical information can live in the IFU instead.

Since the standard only requires labeling to be “appropriate” to the device’s nature and user rather than meeting a fixed technical spec, companies should build their own internal legibility and durability criteria into their labeling procedures.

Symbols are part of this same content requirement. NOM-137-SSA1-2025 includes a mandatory Appendix A with 70 identification symbols (manufacturer identity, expiration dates, sterility, storage, safe use, latex, biological content and IVD-specific symbols) plus a separate 13-symbol hazard table. If a symbol’s meaning isn’t obvious and isn’t already covered in Appendix A, its description must appear within the labeling.

The standard’s bibliography references ISO 15223-1, ISO 15223-2, ISO 7010 and ISO 3864-1 as supporting material. But none of them are declared legally equivalent under Section 7, so they’re reference sources only, not substitute requirements.

Language, Manufacturer, Importer and Origin Information

Manufacturers should not assume an English-language label can be used unchanged in Mexico. NOM-137-SSA1-2025 requires label content to be in Spanish, using comprehensible terms and legible typography and size for the user, while also allowing other languages or measurement systems to be included.

Two specific rules stand out.

• When health information is also expressed in a language other than Spanish, that other-language text may be up to the same size and typographic proportion as the Spanish text, provided it does not oppose or contradict the Spanish version.
• The brand name is the only labeling element the standard expressly permits to remain in a language other than Spanish, when applicable.

Counter-Labeling for Imported Devices

For imported devices whose original label does not fully carry the required Spanish-language health information, the standard allows a counter-label carrying the missing information. This counter-label may be applied inside Mexican territory, after customs clearance and before the device is commercialized or supplied to the public. It must be clear, legible, placed visibly and must not cover health information in a way that compromises the device’s quality or use.

Manufacturer, Importer, Distributor, and Origin Legends

NOM-137-SSA1-2025 treats manufacturer, importer, distributor and Titular del Registro Sanitario as distinct roles. It prescribes the exact legends each one triggers on the label, each followed by the corporate name and address.

A few additional rules apply on top of the legends:

• A country-of-origin legend is required separately. The standard specifically notes that “fabricante” as authorized in the Registro Sanitario is not the same concept as “país de origen,” since the two can differ.
• The required address format includes street, number, neighborhood (colonia), city, state, postal code, and country, and abbreviations are permitted.
• The standard does not use “local representative,” “importer,” and “Titular del Registro Sanitario” interchangeably. Its own definitions separate distribuidor (distributor), fabricante (manufacturer), fabricante legal (legal manufacturer) and Titular del Registro Sanitario as distinct figures, each with a different legal responsibility.

Labeling Rules by Device Type and for Imports

NOM-137-SSA1-2025 sets out additional, device-type-specific requirements in Chapter 6, on top of the general requirements in Chapter 5.

Distinctions include:

• Devices for exclusive use by public health institutions: must carry the Spanish-language legend “Prohibida su venta” (Not for sale) or “Propiedad del Sector Salud” (Property of the Health Sector).
• Radiopharmaceuticals: must show both date and time of expiration.
• Kits/packages: shared registration number, listed components, the shortest expiration date among components and a distinct lot number for the kit.
• Devices incorporating human or animal tissue, blood derivatives, plasma derivatives or a drug: must disclose the presence, quantity and whether it contacts the patient directly.
• In vitro diagnostic agents: extensive IFU content on test type, analyte, sample handling, quality control and performance characteristics, plus a required diagnostic-agent legend.
• Software as a Medical Device: must carry an accessible version or revision-level identifier.
• Devices sized or designed so a full label cannot fit: at minimum, lot number, generic name, brand name, content and expiration date must appear on the primary package, with the rest carried elsewhere in the labeling.

General medical devices without one of these specific triggers just follow Chapter 5. And there’s no separate labeling chapter for “active devices” or “devices with accessories” as their own categories, those terms only show up in definitions, not as dedicated labeling rules.

For foreign manufacturers, the language and legend requirements covered above apply in full to imported devices.

One thing worth stressing though, this is a labeling requirement, not a customs clearance procedure. Customs classification and shipment documentation fall under separate Mexican customs law. A device can be fully compliant on labeling and still face a separate customs process before it reaches the Mexican market.

Instructions for Use and Accompanying Information

NOM-137-SSA1-2025 dedicates a substantial part of Section 5.10.11 to instructions for use (IFU), tying each requirement to a safety or performance purpose rather than listing them as a generic checklist.

IFU content requirements include:

• Any specification needed to use, process, or maintain the device.
• Preparatory handling steps such as sterilization, assembly, configuration or calibration.
• Special facility or user-training requirements.
• Maintenance, cleaning, disinfection and disposal information.
• Handling of hazardous consumables.
• Combination-use information when the device is meant to work with other devices.
• Where the device emits radiation, detailed information on the type and protective measures.

The IFU must also carry the manufacturer’s or legal manufacturer’s name, address and contact information for technical assistance. For IVD agents specifically, the requirements extend further, into test principles, quality-control procedures, analytical performance data and clinical performance data.

COFEPRIS’s Role: Registration, Modifications, and CE Marking

NOM-137-SSA1-2025 sets what a label must say. COFEPRIS, through the Secretaría de Salud, is the separate authority responsible for monitoring compliance and evaluating conformity. It matches label content against the device’s Registro Sanitario, both at manufacturing/distribution sites and during registration review.

A Spanish-language draft label is a required part of the registration dossier, so labeling decisions should happen early, not as a final packaging step.

Changing a label after registration

Adding a new warning, distributor legend, or IFU statement can require a formal modification to the existing Registro Sanitario. COFEPRIS handles this through two procedures:

• COFEPRIS-2022-022-003 (administrative modifications) covers trade name, catalog number, distributor or importer changes. Fees run 50% of the registration fee for name or owner changes and 75% for other changes, ranging $8,249 to $23,098 MXN.
• COFEPRIS-2022-022-004-A (technical modifications) covers manufacturing site, packaging material, expiration date or risk classification changes. Fees run $12,374 MXN for Class I, $18,149 MXN for Class II, or $23,098 MXN for Class III.

Both require submitting an updated Spanish-language label draft. The administrative track resolves in 15 business days, with an interim accelerated option at 10 business days. The technical track resolves in 11 business days. For incomplete filings, COFEPRIS has 4 days to flag missing administrative info or 8 days for missing technical info, and the applicant gets a minimum of 5 business days to respond before the request is dropped.

CE marking’s role

A foreign regulatory mark does not automatically replace a Mexican labeling requirement. NOM-137-SSA1-2025 grants no labeling status to CE marks or other foreign certifications. A separate DOF Acuerdo does let COFEPRIS accept a CE certificate as equivalent GMP evidence, but only for registration purposes, not labeling. A CE mark on packaging is not a substitute for the Spanish legends or registration number the label itself requires.

Staying Compliant After Launch

Compliance doesn’t end once artwork is approved. NOM-137-SSA1-2025 requires document and version control over labeling content, and COFEPRIS enforces this through ongoing checks at manufacturing and distribution sites.

A recurring issue is that the artwork team, regulatory team, local importer and other stakeholders work from different versions of the product information The label may look fine on its own but still conflict with the COFEPRIS submission. That’s where avoidable problems tend to appear.

Common practical mistakes:

• Outdated artwork after a registration modification
• Manufacturer or importer legends that don’t match COFEPRIS records
• Product names that differ from the Registro Sanitario
• Missing Spanish-language content on imports
• Lot or expiration dates in the wrong format
• IFU content that contradicts the physical label
• Uncontrolled or informal translations
• Marketing claims broader than the approved intended use
• Counter-labeling not reassessed after a sourcing change

How Manufacturers Should Prepare for NOM-137-SSA1-2025

This is a practical compliance sequence:

1. Confirm whether the product falls within the scope defined in Section 1.2 of NOM-137-SSA1-2025.
2. Read Chapters 5 and 6 in full against the specific device type and risk classification.
3. Compare current labels and packaging artwork against the exact wording required.
4. Review all Spanish-language content for completeness and accuracy.
5. Verify manufacturer, importer, distributor and country-of-origin legends match current business arrangements.
6. Cross-check label content against the authorized Registro Sanitario file.
7. Determine whether any needed label change also requires a registration modification.
8. Route artwork changes through a controlled document/version process.
9. Keep records showing when and why each labeling update was made.

NOM-137-SSA1-2025 Compliance Timeline

The May 14, 2027 date comes from the standard’s own 360-day rule and is confirmed by Secretaría de Economía’s official tracker.

Costs and Practical Impact of NOM-137-SSA1-2025

NOM-137-SSA1-2025 does not itself specify a fee tied to labeling compliance.

Realistic cost categories to plan for include:

• Internal compliance costs: regulatory review time, document/version control systems, staff coordination between artwork, regulatory and importer teams.
• Printing and packaging costs: label and packaging artwork redesign, inventory transition during the 180-day stock-depletion window.
• Translation costs: professional Spanish-language translation and validation of labels and IFUs.
• Consulting costs: external regulatory affairs or labeling specialists engaged to review compliance.
• Government fees: as covered above, administrative modifications cost $8,249–$23,098 MXN depending on the change type, and technical modifications cost $12,374–$23,098 MXN depending on risk class, with resolution periods of 15 business days (administrative) and 11 business days (technical).

Conclusion

NOM-137-SSA1-2025 updates Mexico’s medical device labeling standard, with detailed requirements in Chapters 5 and 6 covering scope, Spanish-language content, manufacturer/importer legends and the Appendix A symbols. Manufacturers should confirm their products fall within scope and keep labels consistent with what COFEPRIS authorized in the Registro Sanitario..

Artixio supports medical device companies with NOM-137-SSA1-2025 compliance, labeling, and COFEPRIS registration. Learn more about our regulatory services in Mexico or contact us at info@artixio.com.

FAQs

Q1. What is NOM-137-SSA1-2025?

It is the Official Mexican Standard, “Etiquetado de dispositivos médicos,” published in the DOF on May 19, 2026, that sets the health information requirements for medical device labels, IFUs and packaging in Mexico.

Q2. When does NOM-137-SSA1-2025 become effective?

May 14, 2027. That date follows from the 360-calendar-day rule. The standard’s official status as of this writing is “Pendiente” (pending), not yet in force.

Q3. Who must comply with NOM-137-SSA1-2025?

Establishments that manufacture, package, distribute, or import medical devices for commercialization or supply in Mexico, per Section 1.2 of the standard.

Q4. What information must appear on a medical device label in Mexico?

At minimum, and depending on the device, it includes generic name, COFEPRIS registration number, lot/serial number, expiration date, manufacturer or importer legend and any applicable warnings or symbols from Appendix A, per Chapter 5.

Q5. Are medical device labels required to be in Spanish in Mexico?

Yes. Section 5.1 requires health information to be expressed in Spanish, in comprehensible terms and legible typography, without preventing additional languages from also being included.