All medical devices are regulated by Comision Federal para la Proteccion contra Riegos Sanitarios (COFEPRIS) Secretaria de Salud
Medical Device Definition
A medical device is a substance, mixture of substances, equipment, apparatus, instruments (including software needed for proper use or application), used alone or in combination in diagnosing, monitoring, or prevention of disease in humans or auxiliary in the treatment and disability, as well as employees in the replacement, correction, restoration or modification of the anatomy or physiological processes. Guidelines, 1.1.
Classification of Medical Device
|Class I Low Risk||Low|
|Class I||Simple surgical instruments, tongue depressor||Moderate-Low|
|Class II||Digestive catheters, infusion pumps, and powered wheelchairs||Moderate|
|Class III||Dialyzers, and orthopaedic implants||High|
|Postmarket Surveillance ||Must report adverse events and device recalls|
|Language||All documents must be translated into spanish.|
|Expected Time||Class I Low Risk: 1-3 months
All other devices:
Equivalency from recognized country review: 6-8 months.
Standard review: 4-10 months.|