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. 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