All Medical Devices are subject to registration.
Foreign manufacturers must appoint a Local Authorized Representative responsible for submitting the documents required in the registration process to ANMAT.
Argentina Authorized Representative (AAR).
Timeframe and fees
Between 12 months and 15 months.
Labelling and documentation language
Documentation and labelling must be provided in Spanish.
Terminating the business relationship with the Local Authorized Representative and the ANMAT registration holder means starting over again the registration process with another AAR.