Incoterms & Global Trade in Medical Devices

These flashcards cover key concepts and terms related to Incoterms and global trade in the medical devices sector.

EXW (Ex Works)

Seller makes goods available at their premises; buyer handles loading, export, freight, import. Risk transfers at seller’s door.

FCA (Free Carrier)

Seller handles export clearance and delivers goods to carrier; risk transfers when handed to carrier.

FAS (Free Alongside Ship)

Applicable for sea only; seller delivers goods alongside the vessel; risk transfers before loading.

FOB (Free On Board)

Applicable for sea only; seller loads goods on the vessel; risk transfers once on board.

CPT (Carriage Paid To)

Seller pays transport to destination; risk transfers at the first carrier handover.

CIP (Carriage and Insurance Paid To)

Same as CPT, plus seller provides insurance; risk transfers early.

CFR (Cost and Freight)

Applicable for sea only; seller pays ocean freight; risk transfers at loading on the vessel.

CIF (Cost, Insurance, Freight)

Applicable for sea only; same as CFR plus seller buys insurance.

DAP (Delivered At Place)

Seller delivers ready for unloading at destination; buyer handles import.

DPU (Delivered at Place Unloaded)

Seller delivers and unloads at destination; buyer handles import.

DDP (Delivered Duty Paid)

Seller responsible for transport, import clearance, duties, and taxes.

Exporter of Record (EOR)

Legal entity responsible for export declaration and compliance.

Importer of Record (IOR)

Entity legally responsible for import clearance and duties.

Liability of EOR/IOR

Liability follows the legal entity, not the corporate group.

Key Shipping Documents

Includes Commercial Invoice, Packing List, Air Waybill/Bill of Lading, Export Declaration.

Commercial Invoice Requirements

Must include HS code, product description, value, Incoterm, and country of origin.

Country of Origin vs Export Origin

Origin refers to where manufactured; export refers to shipping country.

Dual-Use Goods

Goods with both civilian and military applications.

Restricted Party Screening

Check entities against sanctions lists.

High-Risk Regions

May require extra checks due to sanctions and customs complexity.

Medical Devices & Import Controls

Require health authority approval.

Legal Manufacturer vs Importer

Manufacturer is responsible for compliance; importer is authorized locally.

Missing Regulatory Approval

Shipment may be blocked, returned, or destroyed.

Traceability

Critical for recalls and patient safety.

Causes of Border Delays

Can include wrong HS code, missing documents, sanctions issues, and Incoterm misuse.

Temperature Control

Prevents product degradation and non-compliance.

Importance of Insurance

Damage can cause financial and regulatory loss.

Role Purpose of Insurance

Protects company from customs penalties, delays, regulatory violations, and loss.