All medical devices are regulated by The National Administration of Drugs, Foods and Medical Devices (ANMAT).
Medical Device Definition
A medical product is a health product such as equipment, apparatus, material, item or system of application use medical, dental or laboratory, for the prevention, diagnosis, treatment, rehabilitation or that does not use contraception and pharmacological, immunological, or metabolic to perform its primary function in humans, can meanwhile be assisted in its function by such means. (DisposiciÃ³n 2138/2002).
Classification of Medical Device
|Class I||Simple surgical instruments, tongue depressor||Low|
|Class II||Digestive catheters, infusion pumps, and powered wheelchairs||Low-Moderate|
|Class III||Dialyzers, and orthopaedic implants||High-Moderate|
|Class IV||Coronary stents||High|
|Postmarket Surveillance ||Must report adverse events and device recalls. Post market studies|
|Language||Documents and Labeling must be in Spanish.|
|Expected Time||Class I devices: 1-2 months.
All other devices: Officially the review time is 180 days for all classes of devices, however, actual review time is around one year.|