The National Administration of Drugs, Foods, and Medical Devices (ANMAT) regulates medical devices in South Argentina.
Medical Device Definition
A medical device in Argentina is any equipment, apparatus, material, article, or system used in medical, dental, or laboratory applications for human prevention, diagnosis, treatment, rehabilitation, or contraception. The device must not use pharmacological, immunological, or metabolic means to perform its primary function, although it may be assisted by such means.
Medical Device Classification System
|Simple surgical instruments, tongue depressors
|Digestive catheters, infusion pumps, and powered wheelchairs
|High- Moderate risk
|Dialyzers, and orthopedic implants
|In Vitro Diagnostics
|Diagnosis of non-infectious or non-communicable diseases.
|Diagnosis of infectious diseases except those belonging to GROUP C.
|Diagnosis of sexually transmitted infectious diseases, or transmitted by blood or its derivatives, as well as for identification of blood groups.
|Classes I and II 15 to 30 work days.
Classes III and IV 60 to 110 work days.
GMP 60 work days from the application.
|License validity period
|MD I 39800 ARS
MD II 51250 ARS
MD III 68000 ARS
MD IV 95000 ARS
IVD A and B 36050 ARS
IVD C and D 46150 ARS