Argentina
REGULATORY AUTHORITY: Medical devices are regulated by the ANMAT or Asociación Nacional de Medicamentos, Alimentos y Tecnología Médica (National Administration of Drugs, Foods, and Medical Devices). 

CLASSIFICATION SYSTEM: Devices are classified according to risk following the EU model of Classes I, II, III and IV.

TIMEFRAME: The registration process takes 90-120 days for Class I devices, 180 – 365 days for Class II, III and IV devices and 180- 365 days for IVD devices.  

LICENSE VALIDITY: Licenses issued in Argentina expire after five years. 

AUTHORIZED REPRESENTATIVE: A License Holder is required to register medical devices in Argentina.

Last updated on April 6, 2017.



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For​ more information on registration in Argentina, check out the following articles on our blog:
Country at a Glance: Argentina
 
 
 
 
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