Medical Device Labeling Requirement in Mexico

[karen12]

As linked in below, should the sanitary registration number of the device include in the label for Mexican market? We normally use universal label that complies with CE.

http://www.emergogroup.com/blog/201...ortance-proper-medical-device-labeling-mexico

Please let me know if there are specific requirements for medical device label in Mexico. I would really appreciate if you provide a sample of label.

Thanks.

 

[Stijloor]

A Quick Bump!

Can someone help?

Thank you very much!!

 

[jinggu]

According to NOM-137-SSA1-2008, LABELING OF MEDICAL DEVICES, clause 4.1.1.5 Registration Number issued by the Ministry of Health, it is required to be indicated.
I find this translation of the labeling requirements from Emergo helpful for folks who are not literate in Spanish.
emergogroup.com/sites/default/files/file/mx-cofepris-nom-137-medical-device-labeling-2008-eng.pdf
Jing