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Regulation of Software as a Medical Device in Mexico

Discover how software is regulated as a medical device in Mexico. Understand its classification, the registration requirements with COFEPRIS, and best practices for ensuring compliance with current regulations.

Inside, you will learn about:

  • The essential elements that must be included in your submission

  • How to structure the information correctly

  • Types of requests that require a free-form letter (Escrito Libre)

  • Practical examples of free-form letters

Soluciones globales disponibles localmente

Contacto
  • Eje Central Lázaro Cárdenas 869, Nueva Industrial Vallejo, Gustavo A. Madero, 07700
  • 5551460791
  • salud@ance.org.mx

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