If you have ever wondered what a label is and what is known as a "contraetiqueta" (counter-label), as well as the requirements they must meet, this article from our blog is perfect for you.
In this blog post, we will guide you to understand and reinforce this information and familiarize yourself with the regulatory framework that establishes the characteristics that labels and counter-labels must have.
To begin with, it is important to understand what is indicated in Section II of Article 179 of the Health Supplies Regulation (RIS) and NOM-137-SSA1-2008.
Article 179 of the RIS lists the requirements to obtain the Sanitary Registration of a Medical Device (MD). Number II establishes as a requirement for the project of the label in the Spanish language. Additionally, the same article mentions that the label must comply with the corresponding standard's terms, NOM-137-SSA1-2008.
NOM 137-SSA1 establishes the minimum requirements that must be met to communicate information to users on the labeling of medical devices, whether they are of national or foreign origin, marketed, or intended for use in Mexico. This includes medical equipment; prosthetics, orthesis, and functional aids; diagnostic agents; dental supplies; surgical and healing materials; and hygiene products.
Labels allow for the communication of information to users, and according to the definition of NOM-137-SSA1-2008, they refer to any label, tag, inscription, mark, or graphic image that is written, printed, stenciled, embossed, engraved, adhered, or sealed on any material that can contain the medical device, including the packaging itself.
Unlike the label, the counter-label contains additional or mandatory minimum health and commercial information when the original label does not partially or fully comply with NOM-137-SSA1-2008.
Now that we have covered the regulatory framework and definitions, it's time to review the more practical part of the requirements we must meet to avoid observations from the Health Authority.
The answer is not so simple, as it largely depends on the class, category, and specific characteristics of our MD. However, in general terms, MD labels must comply with the following:
- They must provide complete or additional information (counter-label) in the Spanish language, in accordance with the terms of NOM 137-SSA1. This includes, among others:
- Generic denomination.
- Distinctive denomination.
- Manufacturer's information.
- Country of origin.
- Registration number.
- Lot number or serial number.
- Contents.
- Instructions for use.
- Information about any adverse incidents that may occur due to the use of the product.
- Warning or cautionary statements, if necessary.
- For sterile products, the following statements or symbols must be included:
- "Sterile product."
- "Sterility of the product is not guaranteed if the primary packaging shows signs of prior breakage."
- "Sterilized with ethylene oxide."
- "Sterilized with gamma radiation."
- "Sterilized with dry or moist heat."
- "Processed using aseptic techniques" or other similar statements.
- If applicable, include "Non-toxic," "Pyrogen-free," or other related statements.
- Single-use products must bear the following statements or symbols:
- "Disposable."
- "For single-use only" or similar expressions.
- Reusable sterile medical devices must indicate the methodology for their re-sterilization.
- Symbols for units of measurement must follow the units of the General System of Units of Measurement.
- For formulated devices:
- Include the qualitative formula or the declaration of active ingredients or drug substances contained, as applicable.
- For diagnostic agents, include the statement:
- "Diagnostic agent" and, if applicable, "For exclusive use in Clinical Laboratories or Cabinets."
- The symbols included in normative Appendices A and informative Appendix B of NOM-137-SSA-2008 can be optionally used.
- If applicable, the label or counter-label must include the information indicated in the specific current standards for the product or corresponding pharmacopoeial monographs.
- The label project is submitted in a single copy and in a WORD file and must include the listing of presentations with the description and the code or catalog number of each presentation of the medical device, when necessary.
In conclusion, we can say that both the label and the counter-label play a crucial role in the marketing of MDs. While the original label provides the required basic information, the counter-label acts as a backup, ensuring that no important details are left out. Together, these two pieces form a complete set of necessary data for the sale and proper use of MDs.
We would love to hear your opinion on this topic and if there are any other topics related to Health Regulation that you would like us to address in future articles.
If you have any questions about this topic or need assistance with any procedure before COFEPRIS, do not hesitate to contact us at (+52) 55 6173 2592. We are here to help you with your project.
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