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. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Cuba, free of charge, to expedite the preparation of your medical device or IVD registration application.

 

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.

Last updated on March 17 2015.

For more information on Medical Device Registration in Cuba, check out the following articles:

Other Central America and the Caribbean Countries:

Belize, Costa Rica, Dominican Republic, El Salvador, Guatemala, Honduras, Nicaragua, Panama

 

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