Mexico COFEPRIS Announces Revised Draft Labeling Standard

By Ana Karen Hidalgo Rodríguez

The regulator in Mexico, COFEPRIS, released (March 12) a new project for the NOM for Medical Device labeling, NOM-137-SSA1-2024. This is in part to align with ISO 15223-1:2021, as well as other international expectations. This is a project open for comment. Part two discusses fundamental aspects of the proposed draft standard.

Fundamental General Requirement in NOM-137-SSA1-2024

One of the new concepts considered in NOM-137-SSA1-2024 is that all health information related to identification, technical description, indication for use and correct usage must be in the labeling and can now be complemented electronically. This is through radio frequency identification (RFID), bar or two-dimensional codes, such as QR or any other that may physically accompany the medical device or direct the user to where the health information can be accessed.

According to this update, the elements of medical device labeling must be developed and evaluated based on the level of risk to the patient or user.

Label designs for medical devices

The information on the labels or counter labels must align with the sanitary registrations authorized by COFEPRIS. The user manuals submitted during registration must also comply with this standard.

To support the correct use of medical devices and minimize risks, the NOM now emphasizes that labeling information shall consider the technical knowledge, experience, education and training of the intended users and people with special needs who may use the products. It is also suggested that manufacturers consider the location and environment in which the product is used and the consistent use of terminology. Labeling version control is the responsibility of the manufacturer and the Mexico registration holder.

This update includes a detailed glossary of symbols that must be used on the labels. Other symbols may be used, as long as medical device safety is not compromised by unclear meanings. If the symbol is not in the NOM glossary or an international reference, its description must be in the labeling and must be evaluated in a risk assessment. 

Identification of the medical device

The medical device symbol must be used for all medical devices. This symbol was in ISO 15223-1:2021 and addresses the requirements in the NOM related to the identification of the medical device.

Other requirements include generic name, distinct name, sanitary registration number granted by COFEPRIS, expiration date, manufacturing date, lot number or serial number, catalog number or control or reference or model or code or version number, contents of the medical device and additional labeling for potentially carcinogenic, mutagenic, toxic or endocrine disruptors.

Specific conditions for some of the information

The name of the medical device is the only information that can be in a language other than Spanish. The expiration date section was updated to clarify the date format. The day needs to be included if it applies to the product use. It has also removed the shelf-life restriction of five years.

The date of manufacture was not a requirement in the previous version. While the date of manufacture is now always required, even with the expiration date, this can be part of the lot or serial number as long as it is clearly identifiable.

More is expected in this draft new version of the NOM related to the catalog number, control or reference or model or code or version number, of the medical device. A medical device must be distinguished from other similar devices by the use of a catalog, code control, reference, model or version number or any other method that enables identification of the model and its distinct features.

When the device includes substances or materials that are potentially carcinogenic, mutagenic, toxic or endocrine disruptors for which there is scientific evidence of probable adverse incidents, the labeling must indicate this is the case with a legend or a symbol. This was not a requirement in the previous version.

Concluding remarks

We at Emergo by UL expect that there will be limited changes to the proposed NOM. However, until the consultation closes, and this is published in the official diary, it is not official.

We will continue to report on these rapidly emerging Mexican medical device labeling requirements. Our subsequent posts will cover updates as they are released from Mexican medical device regulators.