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, 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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