Important changes for shipping FDA-regulated healthcare products | myGermany.com
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Exporting Food and Drug Administration (FDA) regulated products to the US has always required shippers to provide mandatory product information set by the FDA on their shipping documentation.

Recently the FDA increased the number of data elements required to complete shipping entries which included the addition of FDA Product and Intended Use Codes, preferably as part of the accompanying commercial invoice or on a separate information sheet. These are compulsory and make entering UNKNOWN (UNK) in any category no longer acceptable.

The new additions apply to all FDA-controlled commodities – medical devices, human and animal drugs and biological products – with the biggest impact being on medical devices. If any part of the accompanying shipping documentation is inaccurate or incomplete, such shipments will no longer be accepted for entry into the US.

As a result, in order to avoid shipment delays, we encourage all FedEx customers exporting FDA-regulated products to make sure their shipping documentation is accurate, complete and fully FDA-compliant.

For more information on how to check that your shipping documentation complies with the new regulations, please click here. Alternatively you can follow the guidelines provided on the FDA website.