Hi All - I have a question pertaining to FDA medical device registration. My company is currently registered as an importer of medical devices. My predecessor registered us as such, and I am questioning now whether we still need to be registered. We do not import any finished medical devices or accessories. We do import medical device COMPONENTS. We sell these components to our customers, the customers assemble the finished devices using our components, and then our
customers sell the finished devices to their
customers. We do not own the overseas facility that manufactures the components for us. We also don't repackage or reprocess the components when we receive them. Instead, we just warehouse them and ship them out when the customer is ready for them. We do provide design assistance for these customers for developing the components where requested, if that makes any difference.
I've been able to get clear direction from the FDA that domestic
manufacturers of components do not need to be registered. However, I have searched everywhere on the FDA website and on the Internet and haven't found such clear direction for importers
of components. Do we still need to be registered as a medical device importer, even though we don't import finished devices? Thanks in advance to all the good folks on elsmar who might be able to provide me direction.