Argentina

Ministry of Health

Ministry of Health

Regulatory Authority

Administracion National de Medicamentos, Alimentos y Tecnologia Médico (ANMAT) (The National Administration of Drugs, Foods and Medical Devices)

Medical Device Regulation

Disposicion N 2124/2011

Mercosur Resolution No. 40 (Classification)

Disposicion N 2318/2002

Disposicion N 727/2013

Official Language

Spanish

Classification

Class I, II, III and IV

Registration Process

– Determine the Classification of the product

– Appoint Argentina Authorized Agent (AAR)

– AAR submits the documents to ANMAT through the HELENA portal and pays registration fees.

– AAR submits a notification to ANMAT for Class I devices prior to placing the device on market.

– Once approved,

ANMAT gives a notification number for Class I devices.

ANMAT provides clearance for Class II, III and IV devices for placing on the Argentina market.