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.
Last updated on November 22nd, 2021.
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.
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