Importing a Medical Device into the US from abroad

#11
Hello Oslap,

did you find the answer/solution to your question. We are medical device manufacturer based in Germany.

As per what we were informed by the US agent who registered our 510 Exempt Class 2 medical device; we ourselves can be the importer (not the Initial Importer) for the medical device and deliver it directly to our potential customers (Hospitals, Clinics etc.).

I am also trying to find out the right way to import our medical device into the US by following the guidelines provided by the FDA i.e. registering on the ACE portal, obtaining the IR number from CBP etc.

DO you know if we ourselves can import the medical device without requiring the initial importer?

Any help or advice would be highly appreciated.
Hello SM190,
did you finally go with an initial importer?
Thx,
 
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mihzago

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#12
Hello Guys,
I am in the same situation and would be interested to see if you made any progress on this subject.

Please find below my findings:
- As a SaMD device (Class II), you can have only a US Agent, that is requested when you list your device on FDA.
- You can perform the role of initial importer as requested by FDA.
but as mentionned by SM1990 I have now to face with importation issues requested by Custom Border Protection (CBP).
Registration on ACE portal requested to choose a way to import (Truck, Air, Rail, Ocean)
(on cbp.gov when you intend to fill-in the ace-import-manifest-documentation)
This is a little bit strange when your software is only downloadable or web based.

Does any of you, have passed this step of importation declaration for a SaMD?

Thank you very much
if you have SAMD that is not on physical media (e.g., CD, flash, etc.) that requires shipment, then you don't need an Initial Importer, and there is no need to register with CBP.
 

mihzago

Trusted Information Resource
#13
The quote from the website is in all caps on the original site--I just copied/pasted.

Unfortunately, the FDA web site does not (and cannot) supersede regulatory language and does not have the force of law (nor does it have the force of informal guidance officially published by the FDA). This would not be the first time a government agency website is wrong. My guess is that the statement on that page comes from the fact that 21 CFR 803.58 was stayed, which is where a lot of people go to to hang their hat without reading the rest of the regulation.

I've cited for you the exact language in 21 CFR 803.3.(l), which provides a "Manufacturer means . . . any person who . . . Is the U.S. agent of a foreign manufacturer." What this means is that everywhere it says "manufacturer" in 21 CFR 803, it applies to the U.S. agent of a foreign manufacturer. What do you think?
I have seen quite a few poorly written regulations. This seems to be one of them, as it introduces a new definition of a manufacturer from 820.3(o).
In this case, I'm pretty sure the intent is Not that the US Agent is the manufacturer, because that doesn't make sense. It would mean the US Agent must also have and be responsible for the entire QSR, including design, production, etc.
Rather, I believe, the intent is that the FDA places responsibility for certain tasks, such as processing complaints, reporting adverse events or recalls in case the foreign manufacturer fails to do that. Also, the FDA (and similarly most other countries requiring local representative) want a person with physical location in the country to communicate and hold the company liable in case these activities are not performed.

Please also note, that the form for submitting adverse events has fields for the manufacturer and initial importer, both of which have to submit a separate report; but, there isn't one for the US Agent.
 

mihzago

Trusted Information Resource
#14
Hello Oslap,

DO you know if we ourselves can import the medical device without requiring the initial importer?
.
You can if you have a physical location in the US. CBP requires an individual with a US address to act as an initial importer, and who takes the legal possession of the product when it crosses the border. The importer is not required to take a physical possession of the product though, which sometimes results in silly situations where the importer "possesses" the product for a fraction of a second (i.e., the time it takes to process the paperwork in the system) because often a distributor takes over the product.
CBP will contact the importer if there are problems with the paper work, for example, the device is not registered with the FDA, or does not have clearance, etc.
 
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