Final Version of Medical Device Labelling Standard (NOM-137-SSA1-2025) by COFEPRIS: Essential Updates You Should Know

Mexico's regulatory authority, COFEPRIS, issued the final version of NOM-137-SSA1-2025, Medical Device Labelling Standard, on May 19, 2026. This publication replaces the draft version released on 23 April 2024 and contains a number of major revisions to the labelling requirements for medical devices.

The final version incorporates several notable revisions to these topics.

Key Changes to Definitions Compared with the 2024 Draft #

New Definition of "Component" #

There's a new definition of component : Any substance, material, or ingredient intended for use in the manufacturing of a medical device intended to be present in the finished device . This definition is of particular relevance for the classification of kits and supports the need for labelling of components in the Instructions for Use (IFU) and on the labelling of the kit.

Revised Definition of Single-Use Medical Device #

The amended definition of single-use medical device further highlights the disposal of the device after a single use. This must be clearly stated by the manufacturer on the product label and the IFU.

Clarification of Stability #

There is one further note under the definition of stability. It now explicitly covers sterile and non-sterile medical devices that have physical, chemical or functional properties that may change over a specified period.

New definitions for manufacturer and legal manufacturer; #

The definitions of “manufacturer” and “legal manufacturer” have been substantially modified. The reform of the wording enhances the legal accountability of the manufacturer – irrespective of whether the manufacturing process is carried out by a third party or not. Moreover, the new definition of manufacturer is more in line with the European Medical Devices Regulation (EU MDR 2017/745).

Revised Definition of Incident #

The definition of an incident has been amended to better reflect the MDR approach. In the meantime, it features incidents which could be due to misuse outside the manufacturer’s intended use, or due to inadequate data provided by the manufacturer.

Broadened Definition of Safety #

The expansion of the definition of safety is based on the concept of risk-benefit assessment, as described in the ISO/IEC Guide 51:2014.

Clarification of Intended Use #

The definition of intended use now includes a new explanatory note, clarifying that indications may be included in the intended use statement. As in the European Union framework, each medical device should have an intended purpose or intended use, although not all devices need to have a separate indication.

Changes to IFU content #

The Instructions for Use (IFU) now must include:

• Device Restrictions
• Precautions regarding potentially carcinogenic, mutagenic or toxic materials

Such information is no longer required to be printed directly on the product label unlike in the draft version.

Device Lifespan Required #

The final standard requires the product label to state the expected lifetime of the medical device. In the draft version, this information was only to be specified in the IFU.

Extended Responsibilities for Registration Holders #

The range of responsibilities of the registration holder has been extended to joint liability with the manufacturer. This includes participation in the definition of the intended use as shown on product labelling and in the contribution to the preparation and revision of the IFU.

Other Significant Updates #

Narrower Scope of the Standard #

The general requirements have been amended to remove the reference to advertising. The standard is now therefore only dealing with labels and secondary labels on primary, secondary and collective packaging.

Symbol Use and Label Material #

The final version contains requirements on the integrity of label materials depending on the type of medical device.

Manufacturers may use symbols other than those in Appendix A, provided the meaning of such symbols is obvious to users. If a symbol is subject to misinterpretation, then supplementary steps need to be taken to ensure that its meaning is clearly conveyed.

The standard also specifies that the Instructions for Use addressed to the general public should be in plain and understandable language, facilitating the safe and intended use of the device.

Software as a Medical Device (SaMD) #

The previously proposed individual listing of labelling requirements for Software as a Medical Device (SaMD) has been replaced.

In spite of this, SaMD products must have a unique identifier (software version, revision number or release/edition date) that is easily accessible to the intended user.

Based on the characteristics of the software and risk assessment according to the final wording, the remaining medical device labelling requirements are expected to apply to SaMD.

Final Remarks #

NOM-137-SSA1-2025 will take effect between Mid-May, 2027 (360 calendar days), one year after its publication.

This final standard includes a number of important labelling requirements including: The obligation to include:

• Intended Use
• Date of manufacture
• Catalog/Model number
• Single use device identification
• Instructions for handling adverse incidents

The content requirements for the Instructions for Use (IFU) are changed substantially in the standard compared to the 2008 version. Many of these additions, such as product preparation, sterilisation, verification procedures and, for in vitro diagnostic devices, test type, determination parameters and intended population align the Mexican requirements with internationally accepted regulations such as the EU MDR and standards such as ISO 15223-1.

The final regulation does not establish requirements for Unique Device Identification (UDI), although NOM-137-SSA1-2025 does allow manufacturers to supplement the labelling through QR codes, RFID and other electronic media. With the 17-year gap between the previous and current versions of the standard, widespread implementation of UDI in Mexico is not likely to occur in the near future.

FAQs #

1. When did the NOM-137-SSA1-2025 become operational? #

It becomes operational 360 calendar days after its publication, which is expected to be around mid-May 2027.

2. What is the primary alteration in the new labelling standard? #

The standard introduces enhanced labelling and Instructions for Use (IFU) requirements that are more closely aligned with international regulations, including the EU MDR.

3. Are manufacturers now required to include the device's expected lifetime on the label? #

Yes. The anticipated service life of the medical device must be specified as part of the labelling information.

4. Does NOM-137-SSA1-2025 require Unique Device Identification (UDI)? #

No. The standard does not mandate UDI. However, manufacturers may use QR codes, RFID, or other digital technologies to provide supplementary labelling information.

5. How does the standard impact Software as a Medical Device (SaMD)? #

SaMD must include an easily accessible unique software identifier. Additional labelling requirements apply depending on the software's risk classification and characteristics.