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.

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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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