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Medical devices in Cuba are regulated by the CECMED (Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos).
Cuba follows the EU model of risk-based classification into Classes I, IIa, IIb, III and IV.
Obtaining a manufacturer’s license takes 1-2 months, while obtaining a product license takes 8-12 months.
License issued in Cuba are valid for five years.
A local authorized representative is not required.
Last updated on March 17 2015.
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For more information on registration in Cuba, check out the following articles on our blog:
Country at a Glance: Cuba