Last April the 4th 2025, the Ministry of Health in Mexico released the official update of the Good Manufacturing Practice (GMP) Norm for Medical Devices (NOM241-SSA1-2025). This new norm will substitute its previous version (NOM241-SSA1-2021), which will become obsolete by November 30th 2025.
This article will be focused on describing the main changes compared to the previous norms and how they will impact the industry. It is worth mentioning that the industry and authorities are still discussing the Norm to solve questions about it. Then, we will be updating this document as we learn more about it.
Applicability
The first point to consider is that this Norm is applicable only for manufacturers, distributors/importers of Medical Devices located in Mexico.
Manufacturers located in Mexico must request a certification to show compliance. This is not applicable for Distributors/Importers, even though it is not clearly stated in the norm.
Then, Manufacturers located outside of Mexico looking to register their products in the country only require presenting the certificates based on the latest GMPs Guides.
It is important to note that an agreement was published in the Official Mexican Diary on March 20, 2025, regarding COFEPRIS criteria for documents that guarantee GMP. According to this announcement, the MDSAP certificate (among another certificates) will continue to be recognized as an equivalent to GMPs for new registrations, renewals, and modifications of sanitary registrations.
In addition, on November 11, 2025, an interpretative criterion was published confirming that compliance with the Medical Device Single Audit Program (MDSAP) is considered equivalent to meeting the Quality Management System (QMS) requirements outlined in Mexico’s Official Standard NOM-241-SSA1-2025 for Good Manufacturing Practices of Medical Devices.
This means that audit reports, verifications, or certifications issued under the MDSAP framework are accepted as valid proof of QMS compliance. When MDSAP documentation is provided, no additional regulatory evaluations, inspections, or audits are required—regardless of whether the manufacturing site is located in Mexico or abroad, or where the products will be marketed.
It should be pointed out that the validity and application of the contents of this announcement relies solely on COFEPRIS’ criteria. We will closely monitor any further developments related to this new announcement.
2021 vs. 2025
The recent modifications to this NOM introduced various changes, starting with the elimination of section 5, which addressed the classification of medical devices. This section was deemed unnecessary for compliance with GMP, as its content is already covered in the Supplement of the FEUM.
Additionally, adjustments were made to clarify the guidelines for the Annual Product Review or Annual Product Quality Review. The updates specify that, based on the nature of the medical device and its associated risks, a different frequency for these reviews might be established. Moreover, new articles were included to define requirements for handling retention samples.
References to risk management were also strengthened, with guidelines now aligned to the appendix “Application of Risk Management to Medical Devices” from the Medical Device Supplement of the FEUM. Additional updates introduced provisions for specific manufacturing lines tailored for software as a medical device, as well as for processes like remanufacturing and refurbishment.
Finally, further clarifications were made regarding stability study requirements, ensuring they are aligned with the FEUM’s updated guidelines for medical devices. Updates also impacted storage and distribution practices, expanding the requirements to include detailed provisions for activities such as back-labeling, aimed at improving compliance and operational standards.
2012 vs. 2021
One of the new chapters included in the 2021 version is about Medical Device warehouses. The NOM241-SSA1-2012 inferred the requirements for warehouses and was not clear if Medical Device warehouses should use this document or the Supplement of the FEUM.
In the NOM241-SSA1-2021, there is a full set of articles clearly related to warehouses. This will have an impact for every Medical Device warehouse in Mexico, since those will require complying with new requirements like:
- A risk assessment system.
- An infrastructure equipment qualification scheme.
- Stricter supplier evaluations.
Regarding the Risk Assessment, this was precisely one of the updates affecting not only warehouses but also manufacturers. In other words, the industry located in Mexico will have to consider bolstering their risk management systems.
If you have any question or comment about this Norm, please feel free to contact us at contact@veraqueconsulting.com.
