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[Emergo, UL] Mexico’s COFEPRIS publishes the final version of the GMP Standard

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..

Our second post on the new draft of the NOM for Medical Device Good Manufacturing Practices (GMP), PROY-NOM-241-SSA1-2024, discusses relevant updates concerning the restructure of content and key changes over the requirements for manufacturers, conditioners, and distributors of medical devices in Mexico. Reorganization of PROY-NOM-241-SSA1-2024This new draft contains several structural changes t..

Background on NOM-240-SSA1-2024The regulator in Mexico, COFEPRIS, released on July 24, 2024, a new draft for the NOM for Medical Device Technovigilance, PROY-NOM-240-SSA1-2024. This update follows a trend of recent revisions over Mexican Standards (Emergo reported on PROY-NOM-137-SSA1-2024, Medical Device Labeling). The current version of NOM-240 was published in 2012, so an update was overdue t..

The regulator in Mexico, COFEPRIS, released a 5.0 edition of the Supplement of Medical Devices of the Mexican Pharmacopoeia (hereafter: Pharmacopoeia), which inserted regulatory requirements for Software as a Medical Device (SaMD). Software was included officially in the definition of medical devices and rule 16 was added to Appendix II to classify software according to risk (Class I, II, or III..

This is our fourth update on the recently released draft standard for medical device labeling published by Mexico’s medical device regulator COFEPRIS, NOM-137-SSA1-2024. Background on NOM-137-SSA1-2024COFEPRIS released (March 12) a new draft of the NOM for Medical Device labeling, NOM-137-SSA1-2024. We posted part 2 and part 3, to further clarify the proposed medical device labeling standard. In..

This is the first in a series of regulatory updates on the labeling standard in Mexico.What is a medical device NOM in Mexico?In simple terms, a Norma Oficial Mexicana is a Mexican regulatory standard that manufacturers meet to protect the safety of medical device, IVD and pharmaceutical users.The Mexican Secretariat of Health is the agency in charge of enforcing the national health policy an..