Medical Device Registration and Approval in Nicaragua

General country-specific regulatory information is provided on this page for medical device registration and approval in Nicaragua. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Nicaragua, to expedite the preparation of your medical device or IVD registration application.

 

Medical Device Regulations and Classification in Nicaragua

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.

Last updated on February 9 2015.

Other Central America and the Caribbean Countries:

Belize, Costa Rica, Cuba, Dominican Republic, El Salvador, Guatemala, Honduras, Panama

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