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.



ARE YOU INTERESTED IN REGISTRATION IN CUBA? REQUEST A FREE QUOTE>​

For​ more information on registration in Cuba, check out the following articles on our blog:
Country at a Glance: Cuba
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