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Software & SaMD Classification

Mexico's approach to Software as a Medical Device (SaMD) is evolving rapidly. COFEPRIS has begun aligning with IMDRF SaMD guidance and the Mexican Pharmacopoeia has introduced SaMD-specific provisions, reflecting the growing role of digital health products.

When software is a medical device​

Software is regulated as a medical device in Mexico when it meets the general definition in the Reglamento de Insumos para la Salud — i.e., it is intended for diagnosis, treatment, prevention, monitoring, or rehabilitation of disease.

Examples of software likely regulated as a medical device:

  • AI-powered diagnostic imaging analysis tools
  • Clinical decision support software with direct diagnostic output
  • Software controlling or monitoring a regulated medical device
  • IVD software for interpreting laboratory results

When software is NOT a medical device​

Software is generally not regulated as a medical device when it:

  • Is used purely for administrative purposes (scheduling, billing, records storage without clinical analysis)
  • Provides general wellness information without disease-specific guidance
  • Simply transmits or stores device data without providing clinical analysis

COFEPRIS's emerging approach​

COFEPRIS is developing its regulatory framework for SaMD in line with IMDRF guidance. The NOM-241-SSA1-2025 GMP standard references SaMD-related requirements, and the Mexican Pharmacopoeia has introduced guidance for software classification.

Regulatory evolution

The COFEPRIS SaMD framework is actively developing. Manufacturers of software products with medical claims should monitor COFEPRIS publications and the DOF for new guidance. See What's New for the latest updates.

Classification pathway for SaMD​

Absent a dedicated SaMD classification rule, COFEPRIS applies the general three-class risk framework:

  • Class I SaMD — low risk, general clinical support, no direct diagnosis output.
  • Class II SaMD — moderate risk, diagnostic tools for non-life-threatening conditions.
  • Class III SaMD — high risk, tools used for diagnosis or treatment of serious or life-threatening conditions.