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. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Argentina, free of charge, to expedite the preparation of your medical device or IVD registration application.

 

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.

Last updated on January 22, 2018.

Other South American Countries:

Brazil, Chile, Colombia, Ecuador, Peru, Uruguay, Venezuela

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