Medical Device Registration in


Medical Device Registration in 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



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.

Documents Required

– Declaration of Conformity

– Device classification information

– Manufacturer Information

– Labelling & IFU

– Technical File

– Certificate of Free Sales or Foreign Govt. certificate

Post-market Requirements

Adverse events must be reported to ANMAT

Legalized/Notarised Documents (if any)

Certificate of Free Sales (FSC) required from recognised countries – Australia, Canada, Japan, US & EU.

Applicable QMS

GMP or ISO 13485:2016

Registration Timeline

Class I & II – 15 working days

Class III & IV – 110 working days

Authorized Representative


License Validity

Class I – Lifetime validity

Class II, III & IV – 5 years

Special Notes

All submission documents must be in Spanish

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