NOM-137-SSA1-2008 — Labelling
NOM-137-SSA1-2008 (Etiquetado de Dispositivos Médicos) is the mandatory labelling standard for medical devices in Mexico. All medical devices marketed in Mexico must carry a Spanish-language label compliant with this NOM.
Publication and status
- Published: 2008 in the Diario Oficial de la Federación.
- Status: In force. A significant draft update (PROY-NOM-137-SSA1-2024) was published for public comment and is under finalisation as of early 2026.
Core requirements
NOM-137-SSA1-2008 requires labels to include:
- Device name (generic and trade name).
- Manufacturer name and address.
- Mexico Registration Holder (MRH) name and address.
- COFEPRIS sanitary registration number (homoclave).
- Lot or serial number.
- Expiry date or manufacturing date.
- Storage and handling conditions.
- Single-use designation ("Para uso único") where applicable.
- Sterility statement and method.
- Warnings and precautions in Spanish.
- Instructions for use reference (full IFU must accompany the device).
Language requirement
All labelling must be in Spanish. Bilingual labels (Spanish + country-of-origin language) are permissible, provided the Spanish content is complete and accurate.
Draft update — PROY-NOM-137-SSA1-2024
A draft revision was published for public comment in 2024. Expected changes include:
- Alignment with current international labelling standards (ISO 15223-1:2021 symbols).
- Updated provisions for electronic or digital IFU (e-IFU) — allowing digital instructions for use under defined conditions.
- Clarification of requirements for combination products.
- Updated provisions for IVD labelling consistent with international practice.
Monitor DOF for publication
As of early 2026, NOM-137-SSA1-2024 had not been formally published. Monitor the DOF and What's New for the finalisation date and any transition period.
Access the official text
Available through:
- DOF (dof.gob.mx) — search "NOM-137-SSA1-2008".
- COFEPRIS website — labelling guidance section.