Skip to main content

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.

Transition guidance (when PROY-NOM-137-SSA1-2024 is published as final): When the updated NOM-137-SSA1-2024 is formally published, COFEPRIS will announce a transition period. Manufacturers will be required to migrate labelling to comply with the new standard by a specified date. During the transition period, existing labels complying with the 2008 version may remain in use until inventory is exhausted, subject to COFEPRIS guidance. Monitor the DOF and COFEPRIS website for transition timeline and any grandfathering provisions.