COFEPRIS (Federal Commission for Protection against Sanitary Risks)
The Federal Commission for Protection against Sanitary Risks, known as COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios), is Mexico’s primary federal authority overseeing the regulation of products and services that impact public health.
Mexico · COFEPRIS
COFEPRIS: What Mexico Device Teams Should Check
COFEPRIS is Mexico’s federal health-risk regulator under the Ministry of Health.
Open the video guideWhat you’ll learn
- COFEPRIS is Mexico’s federal health-risk regulator under the Ministry of Health.
- The General Health Law provides the legal framework.
- For a foreign manufacturer, clarify the Mexican registration-holder and import arrangements.
Read the video transcript
Preparing a medical device for Mexico? You will probably hear, we need COFEPRIS registration. That is a useful starting point, but it is not yet a complete market-entry plan.
COFEPRIS is Mexico’s federal health-risk regulator under the Ministry of Health. Its responsibilities include medical-device authorization, health surveillance and oversight of regulated activities.
Begin with the actual device: its intended purpose, how it is used and the evidence behind its claims. Those details help determine the applicable classification and route.
Mexico’s device guidance distinguishes classes one, two and three. There are also specific low-risk categories and alternative routes, so do not assume every product needs an identical submission.
The General Health Law provides the legal framework. Implementing regulations and official Mexican standards add requirements for areas such as manufacturing quality, labeling and technovigilance.
Review the product label alongside the dossier. Check that the device identity, manufacturer details and intended use remain consistent across the materials you plan to submit.
For a foreign manufacturer, clarify the Mexican registration-holder and import arrangements. Also assign responsibility for product changes, records and safety reporting after the device reaches the market.
An approval from another country does not by itself authorize sales in Mexico. Our COFEPRIS glossary connects the regulator with current official guidance and the next planning steps.
Read the full glossary at Pure Global. One partner for medical device registration and regulatory support across more than thirty markets.
The Federal Commission for Protection against Sanitary Risks, known as COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios), is Mexico’s primary federal authority overseeing the regulation of products and services that impact public health. COFEPRIS’s jurisdiction covers medical devices and in vitro diagnostics (IVDs), pharmaceuticals, biological products, foods and beverages, cosmetics, sanitizing agents, pesticides, tobacco products, organ and blood transplants, and advertising related to health products.
COFEPRIS ensures that regulated products in Mexico meet safety, efficacy, and quality standards throughout their life cycle. This includes evaluating technical documentation to grant marketing authorizations for medical devices and health products, applying risk-based classification systems, and overseeing compliance with Good Manufacturing Practices according to the currently effective NOM-241-SSA1-2021. COFEPRIS has also published criteria concerning a planned NOM-241-SSA1-2025 modification, so manufacturers should distinguish the effective standard from proposed updates. COFEPRIS also enforces post-market monitoring to ensure products maintain compliance and remain safe and effective.
When was COFEPRIS established?
COFEPRIS was officially established on July 5, 2001, as a decentralized body of the Mexican Secretariat of Health.
What medical device regulations does COFEPRIS enforce?
COFEPRIS enforces two key regulations with respect to medical devices in Mexico:
General Health Law (Ley General de Salud), which established the overall regulatory framework for medical devices and pharmaceuticals, and
Regulations of Health Supplies (Reglamento de Insumos para la Salud), which outlines regulatory requirements for medical devices and other health supplies.
Official Mexican Standards (Normas Oficiales Mexicanas, or NOMs) establish technical requirements for areas such as medical device GMP, labeling, and technovigilance. Current registration guidance and electronic procedures are available through COFEPRIS's official medical device portal, including DIGIPRiS.
Does COFEPRIS charge fees?
Yes, COFEPRIS charges non-refundable fees to process registrations, renewals, and modifications. Fees vary by the device's risk classification; higher risk devices cost more to register. However, renewal fees are generally less than registration fees.
How can I contact COFEPRIS?
The best way to contact COFEPRIS for general questions and information is via their toll free hotline at 800 033 5050. COFEPRIS can also be contacted via email at contactociudadano@cofepris.gob.mx.
Website: COFEPRIS
Address: Oklahoma 14 Col. Nápoles, Demarcación Territorial Benito Juárez, Ciudad de México, C.P. 03810.
Phone: 800 033 5050
Email: contactociudadano@cofepris.gob.mx
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