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Ecuador Medical Device Registration Fees
ARCSA government fees for 2025
USD 905
Low Risk Min
USD 905
High Risk Max
ARCSA
Authority
2025-12-16
Last Updated
Complete Fee Breakdown
| Fee Item | Amount | Frequency |
|---|---|---|
MD/IVD Registration All classes | $905 | Per registration |
MD/IVD Renewal All classes | $185 | Per renewal |
Important Notes
- •Flat fee regardless of risk class
- •Low government fees
- •Renewal fee is ~20% of initial
- •Simplified fee structure
Frequently Asked Questions
Government fees are subject to change. Last data update: 2025-12-16. Always verify current fees with ARCSA.