Introduction
Medical Device labeling includes all labels and printed text or graphics directly on the device or its primary or secondary packaging. Worldwide manufacturers follow international standards and local directives or regulations when labeling its products.
However, there are special requirements for medical devices labeling to be distributed in Mexico. In this text we summarize these requirements and some tips to successfully meet local regulations.
NOM-137
The Mexican Official Standard for medical device labeling is the NOM-137-SSA1-2008, Etiquetado de dispositivos médicos (Medical Device labeling).
The aim of this standard is to define the minimal requirements of information to be included in the labels of medical devices to be sold in Mexico.
It is worth mentioning that this technical standard is well aligned with other Mexican and international regulations related to medical devices labeling.
A key point to consider is that the NOM-137, although mandatory, it is flexible enough to allow foreign manufacturers to keep their original labels by only adding missing information as we will explain below.
Key definitions
There are three main definitions that will help us to understand the Mexican regulation related to medical device labeling:
Label: tag, label, inscription, graphic image that has been written, printed, stenciled, marked, embossed, drawn, adhered, or sealed on any material capable of containing the medical device including the container itself.
Back-label, over-label or secondary label: label containing the full or complementary information (to that included in the original label) when the original label of the device does not meet fully or partly the requirements of the NOM-137.
Symbol: design or graphic to complement or substitute information required to be included in the medical device label (NOM-137 appendixes A and B).
An interesting concept is the so called Back-label, over-label or secondary label, this is an especially useful alternative to be in compliance with the Mexican regulation.
Specifically, foreign medical devices companies are allowed to import and distribute their products in Mexico with their original labels without the need of making an especial label for the Mexican market. This reduce operative and logistic costs for the manufacturers. However, original labels must be carefully reviewed and in most cases a Back-label, over-label or secondary labels need to be created to complement the information not originally included.
Back-label, over-label or secondary label
As mentioned, the Back-label, over-label or secondary label consists in a written document that is printed in adhesive paper with the purpose of being attached to the medical device packaging.
The following points must be included in the Back-label, over-label or secondary label when not included in the original label:
- Product trade name (registered trademark)
- Generic name of the product (common name)
- Model(s) and catalog number(s) or part number or reference number
- Sanitary registration number (local approval code)
- Made in (country of origin) by
- Manufactured for (third party manufactured products), when applicable
- Imported (foreign manufactured products) and distributed by
- Batch / serial number
- Expiration date, when applicable
- Storage conditions
- Product sterilized with (sterilization method), when applicable
- Single-use product (not reusable), when applicable
- Description of non-standardized or special symbols on the label
It is important to mention that the Back-label, over-label or secondary label must match the original label, instructions for use or user manual, technical file and sanitary registration issued by COFEPRIS. The sanitary registration holder and/or distributors are responsible for attaching the Back-label, over-label or secondary label after the importation process, but most importantly, before the commercialization.
Conclusions
Medical devices in Mexico must be in conformance with the NOM-137. This norm is a flexible standard to be implemented with original labels by attaching a Back-label, over-label or secondary label before distributing the product in Mexico. Please contact us at contact@veraqueconsulting.com to know more about this topic or any other question you may have about the sanitary regulation in Mexico. You can also check our guidelines with more details about the regulatory process in Mexico.
