Medical Device Registration in
Argentina
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
Medical Device Registration in Argentina
– 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
Yes
License Validity
Class I – Lifetime validity
Class II, III & IV – 5 years
Special Notes
All submission documents must be in Spanish