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 and other aspects of health services, including regulating drugs and medical devices.
In Mexico, a Norma Oficial Mexicana (Official Mexican Standard, NOM), is compulsory. Thus, there are several required medical device NOMS. Unlike ISO standards, there is no prescribed time when NOMs need to be reviewed and potentially revised.
Background on NOM-137-SSA1-2024
COFEPRIS or the Federal Committee for Protection from Sanitary Risks is the department within the agency that deals with the importation of medical devices and issues advertising permits for them.
COFEPRIS released (April 23) a new NOM for the medical device labeling project, NOM-137-SSA1-2024.
This much-needed update (released 16 years after the 2008 version) contains an increased number of definitions reflecting the latest concepts from and other recently updated Mexican regulations, provides further alignment with international labeling regulation (US FDA 21 CFR PART 801, and European Medical Devices Regulation (2017/745, MDR) and In Vitro Diagnostic Devices Regulation (2017/746, IVDR), and GHTF/SG1/N43:2005). The updated NOM elaborates on requirements involving reference technology, such as electronic labeling, bar and QR codes, RFID and labeling for SaMD, as well as an extended appendix of labeling symbols.
Note the acronym advanced for SaMD in both this NOM and edition 5.0 of the Suplemento para Dispositivos Médicos from the Mexican Pharmacopoeia is ScDM, Software Como Dispositivo Médico.
Mexico COFEPRIS Announces Revised Labeling Standard | Emergo by UL
Mexico COFEPRIS Announces Revised Labeling Standard
This is the first in a series of regulatory updates on the labeling standard for medical devices, IVDs and pharmaceuticals in Mexico.
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