General Health Law (Ley General de Salud)

The General Health Law, known in Spanish as Ley General de Salud, is Mexico’s foundational federal health law. Enacted in 1984 and amended many times since, it establishes the legal basis for Mexico's National Health System and for federal controls over health products, services, establishments, advertising, imports, and public-health risks.

How does the General Health Law apply to medical devices?

The law gives Mexico's Ministry of Health authority over medical devices and other regulated health products. COFEPRIS, the federal health-risk authority, exercises many of those functions through the law, its implementing regulations, official Mexican standards (NOMs), agreements, and administrative rules.

For manufacturers, this legal framework supports requirements for sanitary registration, licensed or notified establishments, import permits, compliant labeling, advertising controls, technovigilance, and enforcement. The detailed evidence and procedure for a specific product are not found in the General Health Law alone; they depend on the Health Supplies Regulation, applicable NOMs, classification, intended use, and current COFEPRIS criteria.

Does the law itself grant medical device registration?

No. The law establishes authority and core obligations, while COFEPRIS administers the product-specific authorization process. A foreign manufacturer generally works through a Mexico-based registration holder and should confirm the device's classification and submission route before preparing the dossier. See our Mexico medical device registration overview for the market-access process.

Because the law is amended regularly, use the current consolidated text. Read the official General Health Law (Spanish).

What other rules should be read with Mexico's General Health Law?

The law establishes the high-level legal framework, while regulations, official Mexican standards, COFEPRIS criteria and current administrative procedures provide many of the device-specific details. Manufacturers should use the consolidated legal text together with current Mexico medical device requirements when planning classification, registration, labeling and post-market compliance.