COFEPRIS and Medical Devices

In Mexico, the agency charged with overseeing medical devices is the Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS). COFEPRIS has not only medical devices but also the safety and import of drug and food products into Mexico. COFEPRIS promulgates regulations regarding the importation of medical devices and other medicinal products and works to ensure their safety in the Mexican marketplace.

Process to register a Medical Device in Mexico

Determine the Device’s Class

Classification based on risk

​• Class I: those that are known in the medical practice with a proven safety and efficacy record;
• Class II: those that are known in the medical practice with variations in their materials, and are not usually in the human body for more than 30 days; and
• Class III: those that are known in the medical practice and are usually in the human body for more than 30 days.

Appoint a Local Registration Holder

Get GMP Certificates

Compile Documents for medical device dossier

Present the application for sanitary registration before COFEPRIS

Classification based on funtion and purpose

• Prosthetics, orthotics and functional aids;
• Diagnostic agents;
• Dental supplies;
• Surgical materials; and
• Hygiene Devices.

Legal/Administrative information

Quality information

Good Manufacturing Practices