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, 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.

Other Central America and the Caribbean Countries:

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