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    Guatemala Medical Equipment Import Process (USA → Guatemala)

    This guide helps Guatemalan hospitals, clinics, distributors, and licensed importers understand the process of importing pre-owned medical equipment from the United States.

    Export-Ready Documentation

    All documentation prepared to support Guatemalan customs requirements

    Faster Clearance

    Reduced customs delays through accurate pre-shipment documentation

    Export Support

    From quote to shipment, we prepare equipment for export from the USA

    Regulatory Authority: Departamento de Regulación y Control de Productos Farmacéuticos y Afines (DRCPFA)

    Pre-owned medical equipment can be legally imported into Guatemala with proper documentation and regulatory compliance.

    Classification System

    Class I-IV (I=External Non-Sterile, II=External Sterile, III=Internal Non-Sterile, IV=Internal Sterile/Highest Risk)

    Registration Timeframe

    3-6 months for registration approval

    License Validity

    5 years with renewal

    Local Representative

    Required for foreign manufacturers

    Registration Fees

    • Class I-II: GTQ 500-1,000 (~USD 65-130)
    • Class III-IV: GTQ 1,500-3,000 (~USD 195-390)

    Import Duties and Taxes

    Import duties 0-15% under CAFTA-DR free trade agreement with USA

    VAT Rate

    12% (IVA)

    Additional Charges

    • • Customs processing fees
    • • Sanitary registration fees
    • • Port handling

    Shipping to Guatemala

    Air Freight

    Transit: 5-10 business days

    Airport: La Aurora International Airport (GUA), Guatemala City

    Sea Freight

    Transit: 4-6 weeks

    Port: Puerto Quetzal (Pacific) / Puerto Barrios (Atlantic)

    Buyer Responsibility Notice

    Buyer is responsible for all Guatemalan regulatory approvals including DRCPFA registration, customs clearance, duties, and post-import certification. Rotala International provides export documentation from the USA; all Guatemalan import compliance is the buyer's responsibility.

    Required Documents Checklist

    From Rotala International (USA)

    • Commercial Invoice
    • Packing List
    • Bill of Lading / Airway Bill
    • Certificate of Origin

    Required in Guatemala

    • DRCPFA Product Registration
    • Certificate of Free Sale (notarized and apostilled)
    • Technical documentation and quality certificates
    • Spanish language labeling

    Ready to Import Medical Equipment to Guatemala?

    Browse our available inventory or contact us for a personalized Guatemala export quote.

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