FDA notice on a Paper


Starting to get Involved

During the import of a medical device in USA from China, product was stopped at the entry port and FDA sent a notice on a paper copy. It is mainly about Misbranding branding (haven’t done registration as an importer is what it says). Some consultants tell me that registration is not required as the company is only an importer. This does not look right to me, based on my understanding of 21CFR807 I believe a medical device being imported to the US makes the importer as manufacturer (when label is changed to their name) and hence registration and listing is required. The other scenario would be the company is importing the medical device as an Authorised agent where the Chinese medical device company is already registered with FDA and the authorised agent did not change the label. Is registration required or no? The company is part of the china company (bought by them) and the china company is already registered, so when this company changes the label does it need to register again? And is it required to respond to FDA? If so then how? Considering it’s a paper.
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