Mexico’s COFEPRIS publishes the final version of the GMP Standard

By Pedro Omar Sánchez Neri

We reported in August of 2024, about the publication of a revised draft of the Mexican Standard for Good Manufacturing Practices for Medical Devices, titled PROY-NOM-241-SSA1-2024. In Mexico, a Norma Oficial Mexicana (Official Mexican Standard, NOM), is compulsory. We discussed some of the notable changes proposed by COFEPRIS in contrast with the previous 2021 version of the standard, subject to comment.

This past April 4, the Ministry of Health through COFEPRIS published in the Mexican Official Journal, NOM-241-SSA1-2025.

Important updates to NOM-241-SSA1-2025

This version removes the chapter on Classification of Medical Devices and all references to it. The classification rules are then solely addressed under the Suplemento para Dispositivos Médicos 5.0 from the Mexican Pharmacopoeia.

Descriptions and storage timelines for sample retention requirements are now in a single section.  For formulated products,  IVDs (in vivo), biologic processes and combination products, the scope is reduced to raw materials, primary packaging materials and finished product.

It is worth noting that the new version rewords the objective and scope of the standard to specify this is mandatory only to entities located in Mexico, that manufacture, condition, store and/or distribute medical devices that are also commercialized in Mexico; effectively excluding contract (maquila) manufacturers whose products are sold abroad.

A recent agreement published on March 20 elaborates on this topic, stating that concerning regulatory submissions, although COFEPRIS will accept proof of GMP compliance through certifications such as ISO 13485 under MDSAP, CE Marking or ISO 13485:2016 issued by a notified body for Mexican maquilas subcontracted by a legal manufacturer abroad, this will not be the case for manufacturers in Mexico whose finished products are sold in-country. The GMP regulatory requirement for such entities will be a GMP certification under NOM-241 issued by COFEPRIS.

Definitions of NOM-241-SSA1-2025

In addition to the definitions discussed in our analysis of the draft PROY-NOM-241-SSA1-2024, a few later additions were included in this version that are worth reviewing.

They are:

• Finished product: a medical device that has completed all manufacturing stages and is in its final presentation. This addition provides important context to delineate boundaries to the scope of the NOM.

• Risk management, the systematic application of management policies, procedures and practices, to the tasks of risk analysis, evaluation, control and monitoring. This definition seems to be more in line with ISO 31000 concepts, whereas the previous was aligned with ISO 14971. This new version of the NOM includes many edits delegating suitable criteria over different steps and controls in the manufacturing process, upon risk management.

• in vivo IVDs were also defined in chapter 11 as a separate item, complementing the in vitro IVDs definition, stating that the former will be applied to humans, providing examples such as contrast media, skin tests and others.

All references to unique device identifier (UDI)  have been removed. While this is consistent with the draft version circulated, it officially confirms COFEPRIS’s pause on the UDI system.

Concluding remarks

This new and final version of the Mexican standard for Good Manufacturing Practices for Medical Devices, does not include major revisions nor increases equivalence during conformity assessment with ISO 13485:2016. However, it does clear confusing elements from the previous 2021 version, with improved wording over its scope and objectives. A good example of this are the notes at the beginning of chapters 7 (Design and development), and 18 (Good storage and distribution practices), which outline the specific entities that are required to comply.

Overall, these additions reduce the intricate nature of the previous standard significantly, providing coherence and transparency to the regulated stakeholders in Mexico. In this same spirit, COFEPRIS published an accompanying FAQ guideline which addresses common inquiries from users.

The new NOM-241-SSA1-2025 will come into effect on November 30, 2025, 240 days after its publication in the Official Journal.