FDA Registration and Importing Medical Device Components

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.

A Quick Bump!

Can someone help?

Thank you very much!!

There is often a fine line between what the FDA considers a component and what constitutes a medical device (or a finished part of a medical device). What kind of components do you import? Are they still subject to manufacturing processes by your customers, or could they be considered spare parts in their own right?

Hi "ascherp" - Thanks for responding. I would say the majority of the parts we import are subject to further manufacturing processes. However, there are some parts that basically just get repackaged - and maybe sterilized too - at our customers' facilities. These are things like protective carrying cases for instruments, headbands for surgical headlamps, and extra straps and wraps for patient immobilizers. (The wraps and straps would need to have other components added to or kitted with them, like air pumps or flat boards.) I noticed that some of these parts are listed as spare parts with their own part numbers on our customers' websites or in their catalogs that go with the main device or instrument. Hope that helps.

The component-vs-device issue is defined at 21CFR 807.65(a).

You are an Initial Importer if the products you import are Listed as finished devices by their maker, either as the Manufacturer of the devices; as the Specification Provider if that company is located offshore and the devices are made by a Contract Manufacturer that returns the devices to the Specification Provider to be distributed; or as an offshore distributing Contract Manufacturer. You are not an Initial Importer if the products you import are 21CFR 807.65(a) components.

Legally it's not your call as to how the products are classified by their maker. If however they end up in medical devices, they must have a coherent chain of legal identity and an identifiable location at which they legally become medical devices.

If for instance they are imported by you as components, you could sell them to a medical device maker as components, and that buyer would legally convert them into their final medical device identity. You however could not sell them to an end user, a distributor or a company that is Registered as a Re-Packager, or to any other customer type that would expect the products it buys to be finished medical devices. You also could not sell them to a kit packer that does not List (and if appropriate, obtain pre-market clearance for) its kits based on the rationale that the items in its kits are themselves medical devices, because you would be selling them components instead of medical devices.

It is not possible to be Registered without having at least one Listing. What is the nature of your Listing(s)? If you have Listed a product for which you are the Initial Importer, that Listing implies that the product is a medical device, and implies that the seller of the product to you...or possibly another party that is related to the sale...is Registered and Listed as the regulatorily responsible party for the creation of that product. Does that parallel Listing by the product provider exist?