Mexico’s General Health Law: Video Guide

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.