What is NOM (Norma Oficial Mexicana)? Mexico regulatory standards that manufacturers meet to protect the safety of medical device, IVD, and pharmaceutical users.
Mexico COFEPRIS invalidated the standard NOM-137-SSA1-2008 on medical device labeling published in December 2008, and announced an updated new NOM for medical device labeling, NOM-137-SSA1-2024, on April 23, 2024.
Updated NOM-137-SSA1-2024 complies with international labeling regulations (US FDA 21 CFR PART 801 and European Medical Device Regulations (2017/745, MDR) and In Vitro Diagnostic Devices Regulations (2017/746, IVDR) and GHTF/SG1/N43 :2005). It also contains an expanded appendix of labeling symbols and requirements related to reference technologies such as electronic labeling, barcodes and QR codes, RFID and labeling for SaMD.
The label should contain medical device names, sanitary registration numbers, date of manufacture, lot numbers, management numbers, warnings and precautions.
- The information contained in the label must match that shown on the sanitary registration certificate approved by the Ministry of Health through COFEPRIS.
- The content on the label must appear in Spanish.
- Document management (version management) by the labeling owner or manufacturer is mandatory.
- Label symbols included in Appendix A must be used.
- The label must display the sanitary registration number assigned by COFEPRIS.
Please refer to the link below for more information.
Refer from https://dof.gob.mx/nota_detalle.php?codigo=5724246&fecha=23/04/2024#gsc.tab=0
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