How much does Ecuador medical device registration cost?

Ecuador (ARCSA) medical device registration fees range from $905 to $185 depending on device class. Flat fee regardless of risk class

What fees does ARCSA charge for medical devices?

MD/IVD Registration: $905. MD/IVD Renewal: $185.

Fee structure: Per registration. See the full breakdown for details on each fee category.

ARCSA government fees for 2026

USD 905

Low Risk Min

USD 905

High Risk Max

ARCSA

Authority

2026-01-12

Last Updated

Fee Item	Amount	Frequency
MD/IVD Registration All classes	$905	Per registration
MD/IVD Renewal All classes	$185	Per renewal

DJ Fang

MedTech Regulatory Expert

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Government fees are subject to change. Last data update: 2026-01-12. Always verify current fees with ARCSA.