This article was first published on March 21 and updated on April 26.
The preliminary project of the Official Mexican Standard aims to define the labeling requirements, proper use, and traceability of medical devices for human use in Mexico.
Update
On April 23, 2024, the Ministry of Health, through COFEPRIS, published a draft in the Official Gazette of the Federation (DOF) to modify NOM-137-SSA1-2008. It's important to note that the draft standard will be open for public feedback for a period of 60 calendar days to allow interested parties to express their opinions and submit comments. Once the public consultation period is over, the relevant National Consultative Committee on Standardization evaluates the comments received and decides whether to approve the draft standard with modifications or reject it.
If the draft standard is approved, it will be published in the DOF and enter into force in 180 calendar days. The standard doesn't become enforceable until it's published as an official Mexican standard in the DOF and after the specific timeframe, which we estimate will be by the end of 2024 or the beginning of 2025.
The inclusion of additional terms and definitions is proposed to strengthen safety and quality among the parties involved. Among the proposals is a specific section dedicated to symbols and abbreviated terms. The sections have been reorganized to provide a more cohesive and detailed guide. Guidelines have been expanded and specified, incorporating sections that were not previously present.
Within the “General Requirements” (Requisitos Generales), specifications have been included to facilitate broader access to labeling information using technologies such as radiofrequency, barcodes, and QR codes. Risk management in labeling is addressed, including residual risks. Details such as the manufacturing date and reference number are added, paying particular attention to warnings related to hazardous measures or potentially harmful materials. Additional precautionary measures beyond those established in the NOM are considered, and liability disclaimers are excluded.
Additional usage instructions have been added to optimize the handling and performance of the device. Furthermore, a new section titled "Specific Requirements for the Labeling of Medical Devices" (Requisitos específicos para el etiquetado de los dispositivos médicos) is introduced, aiming to address the particular needs of medical devices such as kits, in vitro diagnostic agents, those containing human-derived materials, software used as a medical device, among others with more specific characteristics and limitations.
Finally, alignment with international standards is adjusted, specifying that there is no equivalence (NEQ) with any International Standard and that additional symbols are considered when labeling medical devices.
It’s important to note that On March 16, The National Commission for Regulatory Improvement (CONAMER) determined that it is not appropriate to grant an exemption for the submission of the Regulatory Impact Analysis (see in Sources) since the new proposal could impose an unexpected administrative burden on the entities subject to the regulation. We are expecting to see how COFEPRIS resolves this observation.
Regulatory framework
The regulatory framework is based on various articles of the Organic Law of the Federal Public Administration, article 39; the Federal Law of Administrative Procedure, article 4; and the General Health Law with articles 3o, 17 bis, 194, 194 bis, 195, 201, 210, 212, 213, 214, 262, 263, 264, 265, and 376. Additionally, the Law of Quality Infrastructure with articles 3, 10, 30, 34, 35, 37, 38, and 139 d, among others, is considered. Furthermore, regulations such as NOM-008-SCFI-2002, NOM-050-SCFI-2004 are considered, including in this draft the NOM-072-SSA1-2012, NOM-240-SSA1-2012, NOM-241-SSA1-2021, and specifying the Pharmacopoeias of the United Mexican States 5.0 and 6th Ed.
Effects from the RA update
The regulated industry should remain vigilant following this consultation period to stay informed about the initiative's outcome. Once accepted, the Standard will be published in Mexico's Official Gazette and become effective after 180 calendar days.
It covers areas that have been recently updated and were absent in other existing regulations. By being more precise and specific, the aim is to establish a more comprehensive and detailed regulatory framework that ensures clarity and structure in the labeling process, guaranteeing quality, safety, and compliance with established standards required in labeling.
The proposal agreement is undergoing internal processes between the National Regulatory Improvement Council (CONAMER) and COFEPRIS and is in a public consultation period.
Written By:
Ana Carla Díaz
About ips
Our regulatory affairs team helps medical device manufacturers obtain the necessary sanitary licenses to commercialize their products in Mexico. We have a deep understanding of the local regulatory framework and a proven track record of success. We offer a wide range of services to meet your specific needs. Contact your service leader or email us at info@insumosparasalud.com to learn more.