H
Hi, stumbled upon this useful website while researching rules and regulations for my business. Would anyone know what the rules are for the following:
I'm looking to import a 510k registered product under my own private label brand. However, the purchase will be made via a supplier (triangular or F2F shipping arrangement) who holds a CE mark and wants to be the 'manufacturer' on the box. My question is does the original manufacturer details need to be on the product box, per FDA rules? Do both the manufacturer and supplier need to be listed on the box? The product itself will be unchanged from the FDA registration description by the manufacturer so I don't think I need to have it registered. To be clear, the supplier itself is European and not registered with the FDA whilst the manufacturer is. I will be relieving the shipment straight from the manufacturer. Thanks in advance!
H
I'm looking to import a 510k registered product under my own private label brand. However, the purchase will be made via a supplier (triangular or F2F shipping arrangement) who holds a CE mark and wants to be the 'manufacturer' on the box. My question is does the original manufacturer details need to be on the product box, per FDA rules? Do both the manufacturer and supplier need to be listed on the box? The product itself will be unchanged from the FDA registration description by the manufacturer so I don't think I need to have it registered. To be clear, the supplier itself is European and not registered with the FDA whilst the manufacturer is. I will be relieving the shipment straight from the manufacturer. Thanks in advance!
H