This article was first published on July 11, 2024.
On July 26, 2024 Mexico published in the Official Gazette of the Federation (DOF, by its acronym in spanish) the draft standard PROY-NOM-241-SSA1-2024, Good Manufacturing Practices for Medical Devices. If approved, this will replace the standard published in 2021.
Update
Last July 26, 2024 COFEPRIS, published a draft in the DOF to update the NOM-241-SSA1-2024 Good Manufacturing Practices for Medical Devices. This publication opens a 60-day public consultation period. During this time, interested parties can submit comments and suggestions to refine the standard before its final implementation.
The update is aimed at being a more specific standard, for example, in the following:
Establishes in its field of application that it applies to the marketing or supply of medical devices in the national territory, considering the related processes in terms of manufacturing, storage, warehouse, and distribution.
Specifies the scope and responsibility of the general management of the organization related to the quality management system (QMS)
Cross-references with regulatory documents, e.g., the medical devices supplement in its 5th ed., for the development of stability studies, validation of software as a medical device (SaMD), and good storage practices, in addition to what the standard describes.
Additionally:
The definitions section was updated, including back labeling, eliminating legal files, and updating SaMD, among others.
The section on risk classification of medical devices, which can today also be found in article 83 of RIS, was eliminated.
The term "performance of a medical device" is added, replacing the current term "functionality."
Regulatory framework
The current standard is the official Mexican standard NOM-241-SSA1-2021 Good Manufacturing Practices which came into force on June 20, 2023 it must be associated with other regulatory documents for its correct interpretation, such as the General Law of Health (LGS, by its acronym in Spanish), the Regulation of Health Supplies (RIS, by its acronym in Spanish) and the Supplements of the Pharmacopoeia of the United Mexican States (FEUM, by its acronym in Spanish).
Effects from the RA update
This project, rather than having radical changes to the current regulations, basically consists of detailing the following in a broader way:
1. The objective talks about the performance of the medical device beyond functionality.
2. In the field of application, it specifically describes that it only applies to establishments that market medical devices in national territory.
3. To ensure correct interpretation, it encourages the consultation of other regulatory documents to consider all the guidelines to be met, in addition to improving the definitions section.
4. Details the scope of the management in relation to compliance with this standard.
Written By:
Alma Vargas Ana Karen Deseusa
About ips
At IPS, we have experts who can advise you on the correct interpretation and implementation of the quality management system to ensure compliance with good manufacturing, storage, and distribution practices for medical devices based on the legal and regulatory framework of the Mexican territory.
Contact your service leader or email us at info@insumosparasalud.com to learn more.