Last December 20th 2021, the Ministry of Health in Mexico released the official update of the Good Manufacturing Practice (GMP) Norm for Medical Devices (NOM241-SSA1-2021). This new norm will substitute its previous version (NOM241-SSA1-2012), which will become obsolete by June 20th 2023.
This article will be focused on describing the main changes compared to the previous norm and how it 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 (this includes Original Equipment Manufacturers) must request a certification to show compliance. This is not applicable for Distributors/Importers, even though it is not clearly stated in the new 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 a recent announcement, made on July 7, 2023, was made that modifies COFEPRIS’ criteria regarding GMP relevance in the context of registrations, modifications, and renewals of Mexican sanitary registries. As stated in the announcement, the MDSAP certificate will now officially be recognized as an equivalent to GMP for the aforementioned processes. This recognition applies to products manufactured both within and outside Mexican territory.
It should be pointed out that the validity and application of the contents of this announcement rely solely on COFEPRIS’ criteria. We will closely monitor any further developments related to this new announcement.
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 new 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.
There are more differences to be considered for manufacturers but at this point we are still learning from the authorities to keep you updated on them.
If you have any question or comment about this Norm, please feel free to contact us at contact@veraqueconsulting.com.
