Medical Device Registration and Approval in Argentina
General country-specific regulatory information is provided on this page for medical device registration and approval in Argentina .
Last updated on November 23rd, 2021.
Medical Device Regulations and Classification in 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, including 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.
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