Sanitary Permit for Importing Medical Devices – Modality C

This document outlines the requirements and procedures for importing medical devices that do not contain narcotics or psychotropics, including those without registration or in the experimental phase.

Importers must provide personal and supplier details, including name, address, phone number, and email, along with general information such as entity type and RFC. The application requires a sanitary permit, which includes a health license, professional ID, technical product letter, and proof of fee payment.

For radiation sources and X-ray equipment, additional permits and certificates from COFEPRIS and health authorities are required. Establishment data and product classification details must also be included.

A declaration section affirms compliance with health regulations, acknowledging the possibility of verification by health authorities.

Source: https://www.ventanillaunica.gob.mx/vucem/Tramites/SALUD.html

Region: Latin America