COFEPRIS or the Federal Committee for Protection from Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios is a decentralized and autonomous body run by a commissioner appointed by the President of Mexico and regulates health facilities, advertising activities, and the manufacturing, import, or export of health products.

Please note that it is not possible for foreign companies to make administrative arrangements for issuing of pre-market approvals directly with COFEPRIS. Foreign companies shall have partner companies legally constituted in Mexico that will be legally responsible for the products imported to and distributed in the United Mexican States.

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