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