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Argentina Medical Device Registration Fees
ANMAT government fees for 2025
ARS 39,500
Low Risk Min
ARS 118,500
High Risk Max
ANMAT
Authority
2025-12-16
Last Updated
Complete Fee Breakdown
| Fee Item | Amount | Frequency |
|---|---|---|
Annual Maintenance - Class I | ARS 39,500 | Annual per product |
Annual Maintenance - Class II | ARS 52,000 | Annual per product |
Annual Maintenance - Class III | ARS 70,000 | Annual per product |
Annual Maintenance - Class IV | ARS 93,000 | Annual per product |
Transfer - Imported Product | ARS 587,700 | Per transfer |
Manufacturer/Importer Authorization | ARS 1,529,400 | One-time |
GMP Verification - Foreign (Main) | ARS 9,439,200 | Per facility |
Important Notes
- •Annual maintenance fees required per product
- •Fees updated every 6 months by ANMAT
- •Registration valid for 5 years
- •GMP verification required for foreign manufacturers
Frequently Asked Questions
Government fees are subject to change. Last data update: 2025-12-16. Always verify current fees with ANMAT.