Mexico COFEPRIS Announces Revised Labeling Standard

By Pedro Omar Sánchez Neri

This is the first in a series of regulatory updates on the labeling standard in Mexico.

What is a medical device NOM in Mexico?

In simple terms, a Norma Oficial Mexicana is a Mexican regulatory standard that manufacturers meet to protect the safety of medical device, IVD and pharmaceutical users.

The Mexican Secretariat of Health is the agency in charge of enforcing the national health policy and other aspects of health services, including regulating drugs and medical devices.

In Mexico, a Norma Oficial Mexicana (Official Mexican Standard, NOM), is compulsory. Thus, there are several required medical device NOMS. Unlike ISO standards, there is no prescribed time when NOMs need to be reviewed and potentially revised.

Background on NOM-137-SSA1-2024

COFEPRIS or the Federal Committee for Protection from Sanitary Risks is the department within the agency that deals with the importation of medical devices and issues advertising permits for them.

COFEPRIS released (April 23) a new NOM for the medical device labeling project, NOM-137-SSA1-2024.

This much-needed update (released 16 years after the 2008 version) contains an increased number of definitions reflecting the latest concepts from and other recently updated Mexican regulations, provides further alignment with international labeling regulation (US FDA 21 CFR PART 801, and European Medical Devices Regulation (2017/745, MDR) and In Vitro Diagnostic Devices Regulation (2017/746, IVDR), and GHTF/SG1/N43:2005). The updated NOM elaborates on requirements involving reference technology, such as electronic labeling, bar and QR codes, RFID and labeling for SaMD, as well as an extended appendix of labeling symbols.

Note the acronym advanced for SaMD in both this NOM and edition 5.0 of the Suplemento para Dispositivos Médicos from the Mexican Pharmacopoeia is ScDM, Software Como Dispositivo Médico.

Definitions now included in NOM-137-SSA1-2024

Some of the most significant concepts included in this new version of the standard are:

In vitro diagnostic agents for self-testing: Medical device for in vitro diagnosis that is intended to be used by personnel who do not have formal training for its use.

Electronic labeling: Any form of labeling content provided by the manufacturer to a medical device user through an accessible electronic medium.

Legal manufacturer: The entity that has the ultimate legal responsibility of confirming compliance with all regulatory requirements that are applied by COFEPRIS to the medical device.

NOTE: Manufacturers are considered those marketing companies that use original equipment manufacturing contracts, OEMs using their brand for products manufactured entirely by other manufacturers.

Real manufacturer: Entity in charge of the manufacturing, assembly, or remanufacturing of a medical device (which may be a subsidiary of the legal manufacturer), or contracted by the legal manufacturer to carry out the manufacturing through a quality or maquila agreement.

Incident/event: Any unexpected or unusual event that is related to the use of a medical device and that may or may not trigger an adverse incident.

Adverse incident/adverse event: Any event that has sufficient evidence of the causal relationship between the incident and the medical device, which could be caused by a deficiency of the medical device, which results in serious deterioration in the user's health and even death.

Set/Package (Kit): The sales configuration of two or more types of medical devices packaged together, intended to be used in the same determination or the same medical procedure. Kit classification is based on the highest class of device provided in the package. All components of the kit must be identified on its label. Each component must comply with the corresponding current regulations.

Outpatient diagnostic tests: Tests performed outside of a laboratory by a health professional, who is not necessarily a laboratory professional, are generally performed in the patient's presence.

Rapid tests: Those used for scrutiny of the measurements of components of medical interest in samples of tissues, fluids, and secretions of the human body that give a rapid result, which laboratory tests and/or a clinic must confirm.

Definitions extracted verbatim from NOM-137-SSA1-2024

A few other definitions like Accessories to a Medical Device, Consumables and Software as a Medical Device are included directly from edition 5.0 of the Suplemento para Dispositivos Médicos from the Mexican Pharmacopoeia , aligning the  medical device regulatory framework in Mexico.

It’s worth noting that the NOM now includes definitions of Performance, Stability and Risk Management to standardize requirements in labeling and instructions for use (IFUs).

Concluding remarks

NOM-137-SSA1-2024 is subject to further commentary, but no significant changes are expected based on previous behavior during consultation on NOM-241-SSA1-2021.

We will continue to share details in subsequent posts, including:

• Label Designs for Medical Devices.
• Identification of the Medical Device
• Warnings, and precautions
• Instructions for Use
• Instructions for Use for IVDs
• Manufacturer’s information
• Special considerations for:
  • Kits
  • Formulated devices
  • Devices with human/animal tissue
  • IVDs
  • SaMD
• Updated Symbols

This is an exciting and much-needed update and hence welcomed.

Pedro Omar Sánchez Neri is Consulting Manager, Mexico at Emergo by UL.