General Health Law (Ley General de Salud)
Mexico’s General Health Law is the foundation for medical device oversight. See how the law, COFEPRIS and product-specific requirements fit together.
MEXICO · VIDEO GLOSSARY
Mexico’s General Health Law, explained
A practical introduction for medical device teams: the legal framework, the role of COFEPRIS and three checks to make before planning a submission.
Open the video guideWhat you’ll learn
- How the law connects to regulations and official standards
- Where COFEPRIS fits into medical device oversight
- What to check before planning a product submission
Read the video transcript
Planning a medical device launch in Mexico? Before the submission checklist, there is a bigger question: what is the legal framework behind the rules?
Mexico’s General Health Law dates back to nineteen eighty-four. It puts the constitutional right to health protection into a national framework for health services and oversight.
Think of three connected layers: the law, the implementing regulations and official standards, then the requirements that apply to your particular product.
This is where COFEPRIS comes in. It carries out key health regulation and surveillance functions under the Ministry of Health, including oversight of medical devices.
For device teams, the scope goes beyond registration. Depending on the product and activity, imports, labelling, establishments and post-market responsibilities also need attention.
The law itself does not approve your device. A complete-looking dossier is only a starting point; the applicable route and supporting evidence still matter.
So begin with three practical checks: your device’s intended use and classification, the current submission pathway, and the Mexican registration-holder arrangement for a foreign manufacturer.
Use the current consolidated law alongside the relevant regulations and standards. Our glossary brings those pieces together, with links to the official source and Mexico guidance.
Explore the full explanation at Pure Global. One partner for medical device registration and regulatory support across more than thirty markets.
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.
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