Mexico’s COFEPRIS Publishes Final Version of Medical Device Labeling Standard

By Pedro Omar Sánchez Neri

COFEPRIS, the regulator in Mexico, published (May 19) the final version of the Labeling Standard for Medical Devices, NOM-137-SSA1-2025. This publication is a revised version of the draft published on April 23, 2024.  At the time, Emergo by UL published a series of regulatory updates: new definitions included, (April 24), standardization of symbols and contents (April 30), warnings, precautions, intended use and instructions for use (May 7), and labeling specifications and manufacturer identification (May 8, 2024). This final release contains a few alterations.

Key differences in definitions from the 2024 draft

There is a new definition for component, defined as any substance, material or ingredient used in the manufacture of a medical device present in the final product, which is later relevant for the definition of kit, and the requirement for these to be identified on the Instructions for Use (IFU) and kit labeling. 

The definition of single-use medical device was also reworded to emphasize the need to discard them after use and to confirm this is reflected on the labels and IFU. 

An additional note was included within the scope of stability to include sterile and non-sterile medical devices in which the physical, chemical or functional properties may be altered or affected within a stated period.

The manufacturer and legal manufacturer definitions were also heavily reworded (replacing each other to a certain extent), elevating the legal manufacturer’s responsibilities into true accountability regardless of whether a third party performs the manufacturing activities. The manufacturer definition is now much more closely aligned with the European Medical Devices Regulation 2017/745  (MDR) definition. 

The definition of incident was also revised to resemble MDR’s more closely, emphasizing its possible misuse per the manufacturer’s indications, or even on behalf of insufficient information provided by the manufacturers. 

The definition of safety was also expanded from ISO/IEC Guide 51:2014’s mentioning the risk-benefit assessment.

 A note was also added to the definition of intended use, stating that the indications may be contained within the intended use. Also, similar to the EU where all devices have an intended purpose/use, though may not possess an indication. 

Other important updates

The first point of the general requirements was revised to remove the reference to advertisement, narrowing the scope of the NOM to labels, and secondary labels within the primary, secondary and collective packaging. 

The integrity of the label material is also addressed as a regulated topic depending on the medical device’s nature, and there is leeway to employ more symbols than those included under Appendix A, as long as their meaning is obvious. Otherwise, additional precautions will need to be in place to confirm its description is legible. This published version highlights that instructions for use intended for the general population must be clear, easy to understand and readily interpretable to support the device being used safely and that it performs as intended.

The IFU must now include device limitations, precautions concerning the presence of potentially carcinogenic, mutagenic, or toxic materials, rather than placing this information on the labeling, as previously required in the draft. 

Unlike the above point, the expected lifetime of the device is expected to be included on the labels, while the draft requested this information on the IFU. 

The scope of the registration holder’s responsibilities is broadened to include shared accountability with the manufacturer, particularly in defining the intended use on the labeling, as well as participation in the development and revision of the IFU.

Software as a medical device (SaMD)

The list of requirements for SaMD was replaced with a unique identifier, such as version, revision, or release/edition date, which must be accessible to the intended user. We can infer that all the other medical device labeling requirements are applicable to SaMD based on its nature and risk assessment considerations.

Concluding remarks

This published version of NOM-137-SSA1-2025 will enter into force on May 14, 2027, one year after publication. It introduces several significant updates, including the requirement to include on the labeling the device’s intended use, manufacturing date, catalog or model number, an indication of whether the device is for single use and instructions on how to proceed in the event of adverse incidents.

In addition to the above, substantial revisions affect the contents of the IFU, as compared with the previous 2008 version of the standard. However, many of these requirements concerning detailed explanations about the product’s preparation, sterilization, verification and (for IVDs) type of test, parameters of determination, or intended population (among others); align with international regulations such as the MDR and international standards such as ISO 15223-1.

It is worth noting that despite NOM-137-SSA1-2025 endorsing the ability to complement the information on the labeling with QR codes, RFID or other electronic media, there is no mention of UDI or its adoption, and considering the 17-year gap between the previous version of the standard and now, we don’t expect this technology to be implemented any time soon in Mexico.