1. Oficina Nacional de Normalización (ONN)

ONN is Cuba’s national standardization authority. It develops and enforces Cuban standards across industries, including safety, performance, and labeling requirements.

2. Ministerio de Comercio Exterior y la Inversión Extranjera (MINCEX)

MINCEX supervises foreign trade and investment, including import licensing and control of conformity for imported goods.

3. Ministerio de Salud Pública (MINSAP)

MINSAP regulates health-related products such as pharmaceuticals, cosmetics, food items, and medical devices. It is responsible for evaluating product safety and effectiveness before they are allowed into the Cuban market.

4. Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos (CECMED)

CECMED is the authority that licenses, registers, and monitors pharmaceutical products and medical equipment.

5. Ministerio de Industrias (MININD)

MININD handles technical regulations, industrial product control, and compliance with national production standards.

6. Aduana General de la República (Cuban Customs)

Customs authorities verify the documentation, labeling, and approval status of imported goods and enforce border compliance checks.

Product Certification and Compliance Requirements

• Standards and Technical Regulations: Products must comply with Cuban technical standards (NC norms). These may be based on national criteria or harmonized with international standards when appropriate.

• Conformity Assessment: Certain categories of goods require prior testing, certification, or evaluation by designated national laboratories or inspection bodies. This includes health-related items, electronics, and industrial equipment.

• Import Authorization: Many products require an import license or authorization from MINCEX before they can be brought into the country. This process involves verifying compliance with Cuban regulations.

• Product Registration: Pharmaceuticals, cosmetics, medical devices, and processed foods must be registered with CECMED or MINSAP. The registration process includes safety testing and local representation.

• Labeling Requirements: Labels must be in Spanish and include product name, country of origin, manufacturer/importer name, usage instructions, production and expiration dates, and any necessary health or safety warnings.

• Customs and Inspection: Goods are subject to verification at customs. Products without proper documentation, registration, or labeling may be delayed, rejected, or confiscated.