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SaMD in Mexico — Overview

Software as a Medical Device (SaMD) is an area of active regulatory development in Mexico. COFEPRIS is progressively aligning with the IMDRF SaMD framework and has begun incorporating SaMD-specific provisions into updated standards, including NOM-241-SSA1-2025 and the Mexican Pharmacopoeia.

What is SaMD under Mexico's framework?​

Mexico applies the general medical device definition from the Reglamento de Insumos para la Salud to software. Software is a medical device when it is intended for:

  • Diagnosis, prevention, monitoring, treatment, or alleviation of disease.
  • Investigation, replacement, or modification of anatomy or physiological processes.

Software that does not meet this intent test — administrative tools, general wellness apps, data storage without clinical analysis — is not regulated as a medical device.

IMDRF SaMD guidance alignment​

COFEPRIS is a member of the IMDRF and is working toward alignment with IMDRF's SaMD guidance documents:

  • IMDRF/SaMD N10 — SaMD: Key Definitions.
  • IMDRF/SaMD N12 — Possible Framework for Risk Categorization.
  • IMDRF/SaMD N23 — SaMD: Clinical Evaluation.
  • IMDRF/SaMD N41 — SaMD: Software Lifecycle Processes.

In practice, COFEPRIS assesses SaMD using the standard three-class risk framework (Class I · II · III) until a dedicated SaMD classification rule is published.

Current regulatory pathway for SaMD​

SaMD manufacturers should:

  1. Determine if the software is a medical device — apply the Reglamento de Insumos para la Salud definition.
  2. Classify the software — using the general risk class framework, considering the severity of the clinical situation and the significance of the software's role in diagnosis/treatment decisions.
  3. Register via standard or equivalency route as applicable.
  4. Ensure GMP compliance — NOM-241-SSA1-2025 includes provisions for software lifecycle processes.
  5. Maintain technovigilance — adverse event reporting for SaMD incidents applies per NOM-240.

The Mexican Pharmacopoeia and SaMD​

The Farmacopea de los Estados Unidos Mexicanos (Mexican Pharmacopoeia) has introduced guidance for SaMD classification, reflecting its role as a reference for device categorisation under the 2025 classification framework. Manufacturers of borderline software products should consult the current Pharmacopoeia edition.

Regulatory evolution

COFEPRIS's SaMD framework is still maturing. Manufacturers with novel SaMD products should consider engaging COFEPRIS early for classification guidance and monitor DOF publications for new SaMD-specific rules.