COFEPRIS Mexico Medical Device Labeling
Medical devices sold in Mexico must have a label that communicates the information necessary to safely use the device.
Medical device labeling in Mexico
Medical device labeling requirements in Mexico are defined by COFEPRIS, Mexico’s medical device regulator. NOM-137-SSA1-2008 is the Mexican standard that outlines the minimum requirements for medical device labeling. In 2024, COFEPRIS released a draft revision of the labeling standard, NOM-137-SSA1-2024. The revision aligns with international labeling requirements under FDA, EU MDR, IVDR, and the International Medical Device Regulators Forum (IMDRF).
Medical devices sold in Mexico must have a label that communicates the information necessary to safely use the device. Labels must be in Spanish, with the exception of the device trade name. The label should be affixed to the device itself or its packaging. The label design should be included with your registration submission to COFEPRIS; and printed labels must align with your approved label design.
Information to include in your medical device label in Mexico
Medical device labels should include the following information:
- Generic name of the product
- Distinctive name of the product
- Manufacturer's data
- Country of origin
- Sanitary Registration number
- The expiry date of the product, when applicable
- Batch number or serial number
- Quantity
- Any adverse incident that may occur from use of the product, when applicable
- Warning or caution legends
- Legends of sterility
- "Non-toxic," "pyrogen-free," or allusive legends, where applicable
- Single use, reusable, etc. using allusive legends or corresponding symbol
- Symbols for units of measurement
- Declaration of their active ingredients or drugs contained, when applicable
Instructions for Use (IFU) requirements for medical devices in Mexico
Instructions for Use contain essential information about how to properly and safely use the device. You must include a printed copy of your IFU. However, the new draft NOM for labeling will allow electronic IFU in acceptable formats, as long as electronic IFU is suitable to the target population and clinical setting for the intended use of the device.
Frequently
Asked Questions
What is a back label or secondary label?
The back label or secondary label is a supplemental label that can be added to your device to comply with labeling requirements in Mexico. NOM-137 allows for medical devices to be imported with their original label that may not be to Mexican labeling standards as long as there is a compliant secondary label.
I need to modify the device label approved in my Sanitary Registration. What should I do?
Your MRH may need to submit a modification to your application with the updated label design. Modifications can take several months to review and approve.
