Question 1

How much does Ecuador medical device registration cost?

Accepted Answer

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

Question 2

What fees does ARCSA charge for medical devices?

Accepted Answer

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

Question 3

Are Ecuador medical device fees annual or one-time?

Accepted Answer

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

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

Ecuador Medical Device Registration Fees