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 updated on November 22nd, 2021.
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.
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