REGULATORY AUTHORITY:

Medical devices and IVDs are regulated by CECMED – Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos.

CLASSIFICATION SYSTEM:

• Medical devices: Class I, IIa, IIb, III
• IVDs: Class A, B, C, D

TIMEFRAME:

• Medical devices (new registration): ~3–4 months
• IVDs (new registration): ~3–4 months

LICENSE VALIDITY:

Licenses (registration certificates) are valid for 5 years. Renewal is generally required before expiry (renewal submission recommended 90 days before expiration).

LOCAL FEES (New Application):

• Medical devices (new registration): fees depend on the selected procedure and class (approx. ~USD 35–70).
• IVDs (new registration): approx. ~USD 19–25 (Class A–D).

LICENSE TRANSFER:

Not applicable

AUTHORIZED REPRESENTATIVE:

A local Authorized Representative (AR) in Cuba is required. The foreign manufacturer must appoint a natural or legal person in Cuba, and the AR must also be registered with CECMED.

ADDITIONAL INFORMATION:

• Not all products require product registration: some devices are exempt if listed by CECMED or considered minimal risk / not meeting the medical device definition.
• Cuba has different registration procedures (A–E) depending on risk class, novelty, and whether the device is on the Sensitive Equipment List (some cases require regulatory audit).
• Foreign manufacturing site registration and inspections can be required, especially for products on the Sensitive Equipment List; however, on-site audit may be waived for products manufactured in certain reference countries (EU, US, Canada, Japan, etc.).
• A 2024 resolution introduced specific requirements for protective-function devices (e.g., surgical masks, respirators, certain radiological protection devices).