In Mexico, the Official Mexican Standard NOM-241-SSA1-2025, Good Manufacturing Practices for Medical Devices, has been published, updating the previous version issued in 2021. This modification, in addition to providing more explicit guidelines, aims to enhance regulatory alignment at the international level.
Update
On April 4, 2025, the Official Mexican Standard NOM-241-SSA1-2025, Good Manufacturing Practices for Medical Devices, was published in the Official Gazette of the Federation (DOF). It will enter into force 240 calendar days after its publication.
The update includes the following:
It applies to medical devices for human use.
It defines the scope of application as the commercialization or supply of medical devices within the national territory, covering processes related to their design, development, manufacture, storage (including conditioning and warehousing), and distribution.
It specifies the responsibility of the organization’s Directorate or Senior Management regarding the Quality Management System (QMS).
It references other regulatory documents to ensure compliance with validation, stability, and risk management activities.
Furthermore:
The section on terms and definitions has been updated.
Section 5, which addressed the risk classification of medical devices, has been removed, as this topic is already covered under Article 83 of the Health Supplies Regulation (RIS).
The content has been reorganized to clarify guidelines that are already part of the current regulations. These are now structured into dedicated sections to facilitate interpretation.
Regulatory Framework
The current standard is the Official Mexican Standard NOM-241-SSA1-2021, Good Manufacturing Practices, which came into effect on June 20, 2023. For proper interpretation, it must be considered in conjunction with other regulatory documents, such as the General Health Law (LGS), the Health Supplies Regulation (RIS), and the Supplements to the Pharmacopoeia of the United Mexican States (FEUM).
Effects from the RA update
This update, rather than introducing radical changes to the current regulations, focuses on clarifying the guidelines. It also reflects a degree of alignment with the provisions of ISO 13485:2016 regarding quality management systems for health products.
Changes include:
The objective specifies that the standard applies to the human-use medical device sector. This section also incorporates the concepts of efficacy and performance of the medical device, replacing the previous focus on functionality.
The scope of application reinstates that the standard applies exclusively to establishments that market health products within the national territory.
The terms and definitions section contains new terms, modifies or updates existing ones, and eliminates certain definitions. For example, includes: medical device performance, risk, relabeling, and relabel. It modifies: complaint, Quality Management System, software as a medical device, and sanitary registration holder. It updates: medical device, and eliminates: legal file.
For accurate interpretation, relevant regulatory documents are cross-referenced in specific sections addressing stability, validation, and risk management.
Also, in general:
The standard restructures or refines the wording and, in some cases, assigns specific numerals to certain guidelines. For example, in the manufacturing systems section, numeral 11.4 now includes guidelines for retention samples. While previously these were embedded within each type of system, they are now unified under a single provision. This same section also introduces specific subsections for software as a medical device, as well as for remanufactured and refurbished products.
Regarding risk management, it is no longer limited to quality risk management, allowing for broader system coverage. The standard also references the section titled “Application of Risk Management to Medical Devices” from the Supplement for Medical Devices of the FEUM.
Regarding stability, it specifies the types of products to which stability studies apply.
Finally, the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) issued a Q&A Guide to clarify common doubts and support the proper interpretation of the updated standard. The document emphasizes that compliance is required for sites established in Mexico and for products marketed within the national territory. It also notes that other certifications relevant to the sector do not replace compliance with this standard or the certification applicable to manufacturing sites. Furthermore, the guide highlights the importance of using the risk management system as a tool for decision-making.
Written By:
Alma Vargas
Ana Karen Deseusa
About ips
At IPS, our experts provide guidance on the correct interpretation and implementation of quality management systems to ensure compliance with good manufacturing, storage, and distribution practices for medical devices, under the current legal and regulatory framework in Mexico.
For more information, contact us at info@insumosparasalud.com.