[Emergo, UL] Mexico COFEPRIS Announces Revised Labeling Standard

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-SSA1-2024

COFEPRIS 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 last part, we discuss the new symbols and share the descriptions.

 

Identification of the medical device manufacturer

The most remarkable changes in this draft are:

• The explanation that the country of origin of the medical device is not to be confused with the real manufacturer, which may differ. The country of origin was required in the previous NOM and while it has not been officially defined to date,  it is understood to be where the devices are shipped from before import into Mexico.
• Abbreviations are now permitted within the address.
• Medical devices imported as samples must be identified according to the manufacturer’s QMS and shall include the statement “Prohibited for sale”.

 

Mexico COFEPRIS Announces Revised Labeling Standard | Emergo by UL

Mexico COFEPRIS Announces Revised Labeling Standard

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