MEDICAL DEVICE REGISTRATION AND APPROVAL IN Cuba

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
Last update: December 2022

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

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