Regulatory Agency
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
Classification |
Low Risk |
Examples |
Class I |
Low Risk |
Simple surgical instruments, tongue depressors |
Class II |
Low–moderate risk |
Digestive catheters, infusion pumps, and powered wheelchairs |
Class III |
High- Moderate risk |
Dialyzers, and orthopedic implants |
Class IV |
High risk |
Coronary stents |
In Vitro Diagnostics |
Class A |
Diagnosis of non-infectious or non-communicable diseases. |
Class B |
Diagnosis of infectious diseases except those belonging to GROUP C. |
Class C |
Diagnosis of sexually transmitted infectious diseases, or transmitted by blood or its derivatives, as well as for identification of blood groups. |
Class D |
For Self-Assessment. |