Related to this discussion but another question: I understand the responsibilities of the initial importer (complaints, tracing), but if we are both the initial importer and distributor of a foreign medical device (class 1), does our address and contact information have to appear on labeling?
If we have a contract with the manufacturer in China stating that we may receive complaints and will forward to them for their tracking and investigation, does that mean that only their contact information can appear on the labeling?
From a business perspective, I believe we should have our contact information on the labeling with the qualifier of "Distributed by:" so that our customers can have a US contact point rather than a China contact point but I cannot find a requirement that a product distributed in the US must have a US contact on the labeling. Everything seems to assume this using US centric terms (city, state, zip code). I am getting pushback from marketing (long story) on having our information on the product and they are challenging me to show them the FDA requirement that shows we must.