Labelling — NOM-137
Medical device labelling in Mexico is governed by NOM-137-SSA1-2008 (Labeling of Medical Devices). All medical devices marketed in Mexico must carry a Spanish-language label compliant with NOM-137.
Core labelling requirements (NOM-137-SSA1-2008)
The label must include:
| Element | Requirement |
|---|---|
| Device name | Generic name and trade name |
| Manufacturer details | Name and address of manufacturer |
| MRH details | Name, address, and sanitary registration number of the Mexico Registration Holder |
| Registration number | COFEPRIS sanitary registration number (homoclave) |
| Lot/batch number | Or serial number, as applicable |
| Expiry / manufacturing date | As applicable |
| Instructions for use | In Spanish; full IFU must be supplied (may be separate document) |
| Storage conditions | Temperature, humidity, light requirements |
| Single-use designation | "Para uso único" — if applicable (cannot be reused) |
| Sterility statement | Method and status if device is supplied sterile |
| Warnings and precautions | In Spanish |
Language requirement
All labelling and Instructions for Use must be in Spanish. Where the device originates from a country using a different language:
- Official certified Spanish translations are required.
- The foreign-language label may be used for registration dossier purposes, but the device placed on the Mexican market must carry a Spanish label.
- Bilingual labels (Spanish + origin language) are acceptable.
Symbols
Standard ISO 15223-1 symbols may be used on labels, supplemented by Spanish text where COFEPRIS specifically requires it. Ensure symbols used are current (ISO 15223-1:2021 supersedes earlier versions).
IFU — Instructions for Use
A full Spanish-language IFU must accompany the device (or be accessible per applicable NOM-137 requirements). It must cover:
- Intended use and indications.
- Contraindications.
- Instructions for use, care, and maintenance.
- Warnings and precautions.
- Expected performance (for IVDs: analytical and clinical performance).
Draft NOM-137-SSA1-2024
A draft update to NOM-137 was published in 2024. The draft has not been finalised as of early 2026. Key expected changes include alignment with current international labelling standards and updated provisions for digital/electronic IFU.
Monitor the DOF and What's New for finalisation of NOM-137-SSA1-2024.
Advertising & promotional claims
Promotional materials for medical devices must not make claims beyond the approved intended use stated in the sanitary registration. COFEPRIS monitors advertising and can take action against misleading or unsupported claims. Permitted claims are limited to what is supported by the registered technical dossier.