Ley General de Salud
Overview of Mexico's General Health Law (Ley General de Salud) and the key articles that establish COFEPRIS authority and the sanitary registration requirement for medical devices.
Reglamento de Insumos para la Salud
The Health Supplies Regulation (Reglamento de Insumos para la Salud) — the principal secondary legislation governing medical device classification, registration, GMP, and post-market obligations in Mexico.
NOMs Overview — Official Mexican Standards
What Normas Oficiales Mexicanas (NOMs) are, how they differ from voluntary standards, and the key device-related NOMs manufacturers must comply with.
NOM-241-SSA1-2025 — Good Manufacturing Practices
The legislative detail of NOM-241-SSA1-2025 — scope, structure, key changes from the 2021 version, ISO 13485 equivalency, and how to access the official text.
NOM-137-SSA1-2008 — Labelling
The legislative detail of NOM-137-SSA1-2008 (medical device labelling in Mexico) and the status of the draft NOM-137-SSA1-2024 update.
NOM-240-SSA1-2012 — Technovigilance
The legislative detail of NOM-240-SSA1-2012 (installation and operation of Mexico's technovigilance system) and the significant draft 2024 update.
Recent Amendments & Consultations
Tracker of recent and upcoming changes to Mexico's medical device regulatory framework — new NOMs, COFEPRIS decrees, and open consultations.