MEDICAL DEVICE REGISTRATION AND APPROVAL IN Nicaragua

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
Last update: December 2022

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.

 

Other Central America and the Caribbean Countries: Belize, Costa Rica, Cuba, Dominican Republic, El Salvador, Guatemala, Honduras, Panama

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