Guatemala has an established product compliance system that combines national technical regulations with regional harmonization under the Central American Integration System (SICA). The country emphasizes consumer safety, product labeling, and conformity of imported goods.

Key Authorities:

• Dirección de Atención y Asistencia al Consumidor (DIACO) – Oversees consumer protection, including product labeling, advertising, and fair trade practices.

• Ministerio de Salud Pública y Asistencia Social (MSPAS) – Regulates food safety, cosmetics, pharmaceuticals, medical devices, and health supplements.

• Ministerio de Economía – Dirección de Administración de Comercio Exterior (DACE) – Manages technical regulations and foreign trade policy.

• Superintendencia de Administración Tributaria (SAT) – Customs authority responsible for import documentation, duties, and verification.

• Comisión Guatemalteca de Normas (COGUANOR) – Develops national standards and promotes conformity with international and regional norms.

Key Compliance Elements:

• Standards and Certification: Many product categories follow harmonized Central American Technical Regulations (RTCA). In other areas, international (ISO, Codex) or U.S. standards are accepted.

• Product Registration: Required for pharmaceuticals, medical devices, cosmetics, and processed food. Registration is done through MSPAS and requires technical dossiers and safety data.

• Labeling Requirements: Labels must be in Spanish and include product name, ingredients, net content, country of origin, usage instructions, manufacturer/importer details, batch/lot number, and expiration date (where applicable).

• Conformity Assessment: Some regulated products may require testing or certificates of conformity. High-risk goods may need pre-market approval or health permits.

• Import Oversight: Customs (SAT) verifies compliance documents, such as registration certificates, invoices, and conformity declarations.