Medical Device Registration and Approval in Cuba
General country-specific regulatory information is provided on this page for medical device registration and approval in Cuba. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Cuba, to expedite the preparation of your medical device or IVD registration application.
Medical Device Regulations and Classification in Cuba
REGULATORY AUTHORITY: Medical devices in Cuba are regulated by the CECMED (Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos).
CLASSIFICATION SYSTEM: Cuba follows the EU model of risk-based classification into Classes I, IIa, IIb, III and IV.
TIMEFRAME: Obtaining a manufacturer’s license takes 1-2 months, while obtaining a product license takes 8-12 months.
LICENSE VALIDITY: License issued in Cuba are valid for five years.
AUTHORIZED REPRESENTATIVE: A local authorized representative is not required.
Last updated on March 17 2015.
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