Global Trade United States
The Arthrex U.S. Global Trade department manages imports of goods into the United States to ensure Arthrex remains compliant with U.S. Customs and Border Protection and U.S. Food and Drug Administration import requirements for medical devices, their components and parts.
Contact U.S. Global Trade (Imports@arthrex.com) if you have questions regarding Customs, FDA or other government agency import requirements.
U.S. Customs Requirements
U.S. Customs requires a complete and accurate English language declaration of the goods.
As an Arthrex supplier, you must provide the information below on your Commercial Invoices and shipment summaries to enable Arthrex to import your products. This information is mandatory:
Commercial Invoice Details
- Invoice number, terms of sale
- INCOTERMS / Terms of delivery
- Shipper / exporter’s full name, address and tax identification number
- Ship-to name and address as instructed by the Buyer, and specified on the purchase order
- Arthrex purchase order number
- Arthrex part number as shown on the purchase order
- A complete and accurate description of each product
- Harmonized Tariff Schedule (HTS) classification number
- Product Value – must reflect purchase price of each item; if you send an item at no charge, then include its cost or the Fair Market Value of a similar product.
- Components or materials provided by Arthrex at a discount or free, (e.g. packaging materials, suture components, and implant components)
- Customized or special packaging that exceeds normal packing or packaging costs.
- Currency
- Country of Origin (COO), and upon request, provide a Certificate of Origin positively affirming the country of origin of all materials.
- Notify the Supply Chain Buyer and U.S. Global Trade department immediately (Imports@arthrex.com) if you change the country of origin of any item you sell to Arthrex.
Food and Drug Administration (FDA) Requirements
If you sell Arthrex an FDA regulated item, you are required to register with the FDA and list all products manufactured to Arthrex specifications.
Registration with FDA is required for:
- Manufacturers, Contract Manufacturers and Remanufacturers
- Sterilizers
- Kit Assemblers
- Contract Packagers
- Specification Developers
You are also required to provide Arthrex FDA medical device information on the Commercial Invoice at the time of the shipment:
- Actual / contract manufacture, name and address
- The FDA product code for the item
- The manufacturer’s FDA registration number – DEV
- The product device listing number associated with the manufacturer – LST
- 510k number if applicable – PMN
For more information, refer to the Arthrex U.S. Import Logistics Instructions and Importing FDA Regulated Items.