Colombia Medical Equipment Import Process (USA → Colombia)
This guide helps Colombian 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 Colombian 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: Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA)
Pre-owned medical equipment can be legally imported into Colombia with proper documentation and regulatory compliance.
Classification System
Class I, IIa, IIb, III (aligned with EU MDR)
Registration Timeframe
6-12 months for new registration
License Validity
10 years for most devices
Local Representative
Required for foreign manufacturers
Registration Fees
- • Class I: COP 1,500,000 (~USD 375)
- • Class IIa: COP 3,000,000 (~USD 750)
- • Class IIb-III: COP 5,000,000-8,000,000 (~USD 1,250-2,000)
Import Duties and Taxes
Import duties 0-15% under US-Colombia Trade Promotion Agreement
VAT Rate
19% (IVA)
Additional Charges
- • INVIMA registration fees
- • Customs agent fees
- • Port handling
Shipping to Colombia
Air Freight
Transit: 5-10 business days
Airport: El Dorado International Airport (BOG), Bogotá
Sea Freight
Transit: 4-6 weeks
Port: Port of Cartagena / Port of Buenaventura
Buyer Responsibility Notice
Buyer is responsible for all Colombian regulatory approvals including INVIMA registration, customs clearance, duties, and post-import certification. Rotala International provides export documentation from the USA; all Colombian 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 Colombia
- INVIMA Sanitary Registration (Registro Sanitario)
- Colombian Importer Authorization
- Certificate of Free Sale
- ISO 13485 certification or equivalent
- Spanish labeling and Instructions for Use
Ready to Import Medical Equipment to Colombia?
Browse our available inventory or contact us for a personalized Colombia export quote.