Puerto Quetzal (GTPRQ)

Surgical devices that require an inscription are intended for cutting the skin or a membrane, or which touch blood, such as syringes or finger pricks. Devices such as anesthetics and asthmatic inhalers, high pressure measuring apparatus, laser-guided apparatus and others do not require an inscription. These would be classified under medical equipment and supplies and undergo normal customs clearance procedures. Pharmaceutical products, including but not limited to specialty pharmaceuticals, homeopathic, radiopharmaceutical, supplements, biological, biotechnology and allergens require a Sanitary permit to be imported and commercialized in Guatemala. A simplified list of requirements for obtaining a sanitary permit is below: * 1. Fill and submit the appropriate forms in original and duplicate 2. Product formula and composition (mention both common and scientific names) (using appropriate form) 3. Sanitary license, valid or prior license (usually from FDA or PAHO) 4. Legalized copy of the Trade Mark registry 5. Free Sale Certificate from the country of origin; CBL approved by a recognized organization such as the OMS 6. Monograph study, when it is a new product 7. Product description 8. Product specifications 9. Method of analysis used 10. Packaging materials used (a sample), originals and copy 11. Instructions on label in Spanish 12. Copy of contract (in case of manufacture under drawback or “maquila” law) 13. Stability study for products with 24 months life expectancy or more, according to product 14. Samples 15. Bio-equivalence study, when applied 16. Standard of raw material of active principle/s for new molecules 17. Copy of the Sanitary License of the local distributor 18. All foreign language documents must be legally translated into Spanish.