Argentina

The information on this page is valid and current. The legislative and regulatory provisions are subject to changes and updates by the Regulatory Authorities of the State to which they refer. Considering the above, the writer declines all responsibility regarding any non-actuality and/or inaccuracy of the information received concurrently with or following the publication of this page Disclaimer


 

Regulatory Authority:
Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT)

Classification:
I, II, III, VI

Quality System:
ISO 13485

Procedure:
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.

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Applicant:
Argentina Authorized Representative (AAR)

Timeframe and fees:
Between 12 months and 15 months

Validity:
5 years

Labelling and documentation language:
Documentation and labelling must be provided in Spanish.

Useful information:
Terminating the business relationship with the Local Authorized Representative and the ANMAT registration holder means starting over again the registration process with another AAR.

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