Medical Device Import Documents: Build the Checklist Before You Buy

Product identity documents

Start with intended use, model/configuration, manufacturer identity, product specifications and labeling. These fields anchor every later check.

Regulatory and quality documents

Request only evidence relevant to the specific product and market. Check scope, holder, issuer, validity, version and whether translation or legalization is required.

Commercial and shipment documents

• Quotation, contract and invoice
• Packing list and transport documents
• Country-of-origin or other requested trade evidence
• Inspection or batch documents required by contract

Assign responsibility

The buyer, importer, authorized representative, manufacturer and logistics providers may have different duties. Record who confirms each item instead of assuming the supplier owns the whole import process.