General country-specific regulatory information is provided on this page for medical device registration and approval in Nicaragua .
We review our Regulatory Information frequently; please check back often for updates
REGULATORY AUTHORITY: Medical devices are regulated by the MINSA or Ministerio de Salud (Ministry of Health).
CLASSIFICATION: Medical devices are divided into four classes (I, II, III, IV) based on risk level.
TIMEFRAME: The registration process takes around 2-3 months.
LICENSE VALIDITY: Licenses issued in Nicaragua expire after five years.
Other Central America and the Caribbean Countries: Belize, Costa Rica, Cuba, Dominican Republic, El Salvador, Guatemala, Honduras, Panama
For detailed device-specific compliance information for each market, including Nicaragua , to expedite the preparation of your medical device or IVD registration application.
Did you know you can onboard your medical device or IVD compliance information to our system in less than 15 minutes?
And, in less than a minute, you can start your device-specific registration application and a complete county-specific registration process in this country or any of the other 140+ countries available for you through the Arazy Group Medtech registration platform.
