CLASSIFICATION SYSTEM:

Medical devices: Class I, II, III, and IV.

IVDs: Class A, B, C, and D.

TIMEFRAME:

Medical devices: 60 days.

IVDs: 90 days.

LICENSE VALIDITY: Licenses issued in Argentina expire after five years.

LOCAL FEES (New Application):

Medical devices:

Class I: ~. USD 238.

Class II: ~. USD 307.

Class III: ~. USD 406.

Class IV: ~. USD 567.

IVDs:

Class A, and B: ~. USD 221.

Class C and D: ~. USD 267.

LICENSE TRANSFER: License transfer is possible. The application of license transfer must be submitted with the requirements established in the Annex IX of Disposicion No. 9688/2019. The dossier evaluation will take 50 days.

AUTHORIZED REPRESENTATIVE: A License Holder is required to register medical devices in Argentina.

ADDITIONAL INFORMATION: 

For a foreign manufacturing facility, an application for BPF/GMP certification must be submitted to ANMAT. An on-site inspection will be required for a manufacturer who is not located in countries with stringent regulatory framework such as USA, Australia, Canada, Switzerland, Member States of the European Union, Israel and Japan, otherwise only desktop/remote inspection is required. There are 2 pathways that can be chosen:

Regular pathway – is applicable for manufacturing facility located outside Mercosur member states.

Mercosur pathway – is applicable for manufacturing facility located in one of Mercosur member states