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.

We review our Regulatory Information frequently; please check back often for updates

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.


Other Central America and the Caribbean Countries: BelizeCosta RicaDominican RepublicEl SalvadorGuatemalaHondurasNicaraguaPanama

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For detailed device-specific compliance information for each market, including Cuba, to expedite the preparation of your medical device or IVD registration application.


Did you know you can onboard your medical device or IVD compliance information to our system in less than 15 minutes?

And, in less than a minute, you can start your device-specific registration application and a complete county-specific registration process in this country or any of the other 140+ countries available for you through the Arazy Group Medtech registration platform.

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