Importing a Medical Device into the US from abroad

O

Oslap

#1
Hi,

we're going to import a Class II medical device with a 510(k) Exempt into the US and sell it on Amazon. We are both manufacturer and exporter of the product and we will be getting an FDA registration in October.

Meanwhile, we need to solve an Initial Importer question. Usually for a non-FDA products, a foreign entity can act as an Importer of Record and get the shipment into the US. However, as we understand here, for a medical device we need to get a special "Initial Importer" entity who is also registered with the FDA.

Now, we have two options:
1, Either create our own US company, register it with the FDA and be our own Initial Importer. The problem is we need a physical presence with an actual office and people which we will hopefully eventually do, but right now it is an overkill.

2, Or get an existing Initial Importer to handle import and Medical Device Reporting duties for us.

The problem is - I can't find any company like that. It was easy to find an US Agent for the FDA registration, but I struggle with an Initial Importer entity. Does anyone know a company like that please?

Also, if we get an established Initial Importer in the US - is it necessary to physically send the goods to him or is it OKAY to use Amazon as our Ultimate Consignee and send the product directly to their warehouse?

Any other tips regarding import of a medical device into the US are welcome.

Thank you.
 
Last edited by a moderator:
Elsmar Forum Sponsor
#2
Hi,

we're going to import a Class II medical device with a 510(k) Exempt into the US and sell it on Amazon. We are both manufacturer and exporter of the product and we will be getting an FDA registration in October.

Meanwhile, we need to solve an Initial Importer question. Usually for a non-FDA products, a foreign entity can act as an Importer of Record and get the shipment into the US. However, as we understand here, for a medical device we need to get a special "Initial Importer" entity who is also registered with the FDA.

Now, we have two options:
1, Either create our own US company, register it with the FDA and be our own Initial Importer. The problem is we need a physical presence with an actual office and people which we will hopefully eventually do, but right now it is an overkill.

2, Or get an existing Initial Importer to handle import and Medical Device Reporting duties for us.

The problem is - I can't find any company like that. It was easy to find an US Agent for the FDA registration, but I struggle with an Initial Importer entity. Does anyone know a company like that please?

Also, if we get an established Initial Importer in the US - is it necessary to physically send the goods to him or is it OKAY to use Amazon as our Ultimate Consignee and send the product directly to their warehouse?

Any other tips regarding import of a medical device into the US are welcome.

Thank you.

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.
 

gogreen

Starting to get Involved
#3
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, have you guys found an initial importer? I can you with a company. What is the best way to contact you?
 

gogreen

Starting to get Involved
#4
Hi,

we're going to import a Class II medical device with a 510(k) Exempt into the US and sell it on Amazon. We are both manufacturer and exporter of the product and we will be getting an FDA registration in October.

Meanwhile, we need to solve an Initial Importer question. Usually for a non-FDA products, a foreign entity can act as an Importer of Record and get the shipment into the US. However, as we understand here, for a medical device we need to get a special "Initial Importer" entity who is also registered with the FDA.

Now, we have two options:
1, Either create our own US company, register it with the FDA and be our own Initial Importer. The problem is we need a physical presence with an actual office and people which we will hopefully eventually do, but right now it is an overkill.

2, Or get an existing Initial Importer to handle import and Medical Device Reporting duties for us.

The problem is - I can't find any company like that. It was easy to find an US Agent for the FDA registration, but I struggle with an Initial Importer entity. Does anyone know a company like that please?

Also, if we get an established Initial Importer in the US - is it necessary to physically send the goods to him or is it OKAY to use Amazon as our Ultimate Consignee and send the product directly to their warehouse?

Any other tips regarding import of a medical device into the US are welcome.

Thank you.
Oslap, have you had any luck on this front? I'd love to hear how you resolved this.
 

gogreen

Starting to get Involved
#6
here's one company providing US Agent/Initial Importer services that I interacted with and has reasonable fees and requirements.
Dawa Medical | A Medical Device Consulting Company
I'm not so sure. Their website says "PLEASE NOTE THAT THE U.S. AGENT HAS NO RESPONSIBILITY RELATED TO REPORTING OF ADVERSE EVENTS UNDER THE MEDICAL DEVICE REPORTING REGULATION (21 CFR PART 803)" which is not correct. I've seen stuff like this from other companies marketing these services but don't actually know or follow the regs and, because of this, charge low rates.

Although 21 CFR 803.58 has been indefinitely stayed since 2014, that doesn't change the requirements imposed on US Agents elsewhere in the regulations.

A US Agent's failure to properly carry out MDR obligations is a risk to foreign manufacturers. The US Agent must comply with all 21 CFR 803 requirements applicable to the manufacturer pursuant to 21 CFR 803(l) (snippet below). The disclaimer on their website above tells me all I need to know.

21 CFR 803.3(l):
"Manufacturer means any person who manufactures, prepares, propagates, compounds, assembles, or processes a device by chemical, physical, biological, or other procedure. The term includes any person who . . . Is the U.S. agent of a foreign manufacturer."
 

mihzago

Trusted Information Resource
#7
That statement in all caps you cited as incorrect actually comes from the FDA’s website, word for word.
U.S. Agents
So, no, a US agent is not directly responsible for MDRs. I’m sure they would be involved in communication between the FDA and the foreign manufacturer though.

MDRs is a requirement for Initial Importers.
 

gogreen

Starting to get Involved
#8
That statement in all caps you cited as incorrect actually comes from the FDA’s website, word for word.
U.S. Agents
So, no, a US agent is not directly responsible for MDRs. I’m sure they would be involved in communication between the FDA and the foreign manufacturer though.

MDRs is a requirement for Initial Importers.
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?
 
#10
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
 
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