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.
Good Manufacturing Practices
REGULATE supports you in the whole process for obtaining the sanitary registry