Import-Export of Medical Device components into the US

P

pourshams

#11
Hello,

I'm sorry now I have a different question. What if we manufacture the medical device and solely sell it to an export company in USA which exports it outside US. What type of establishment we should register under and what type of establishment the exporter should register under.

thanks very much for the help
 
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Ronen E

Problem Solver
Staff member
Moderator
#12
Hello,

I'm sorry now I have a different question. What if we manufacture the medical device and solely sell it to an export company in USA which exports it outside US. What type of establishment we should register under and what type of establishment the exporter should register under.

thanks very much for the help
Who is the named responsible manufacturer of the device you manufacture (i.e. whose name and contact are on the label)? Is it your company or the export company you sell to?
 
P

pourshams

#13
It will have our label on it. but we can have a contract drafted with the exporter that they can only export this outside USA. Not sure how we should register with FDA here and how our exporter should register.
Thanks
 

Ronen E

Problem Solver
Staff member
Moderator
#14
It will have our label on it. but we can have a contract drafted with the exporter that they can only export this outside USA. Not sure how we should register with FDA here and how our exporter should register.
Thanks
You will have to register as a Manufacturer, and your "export company" customer will not need to register (at least in the context you provided). They will be acting as a distributor.
 
E

ElmerF

#15
Medical devices company based in Europe (Class II): Just loking for clarification on terminology: is the US authorized representative the same thing as the US agent which is the only definition I can find on the FDA website? The US agent has no responsibility to report adverse events so is it sufficient that they alert us to complaints or do we need to have another facility based within the US to ?Maintain complaint files as required under 21 CFR 820.198?.

I am also trying to determine if they should register with FDA but it seems from the listing below that only the initial importer does so.

We had planned to send product directly to distributors in the US but are we required to use an initial importer for all shipments and have the shipments distributed by the initial importer to the individual distributors? If the US Agent/Authorized Representative is not the initial importer but we decide to use our OEM?s US facility does the US agent not have to register their facility?

Would it be a possibility to have each distributor be an initial importer (and thus registered) or can there be only a single initial importer.

Would appreciate any input.

Thanks,

ElmerF


U.S. Agents
Any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device imported into the United States must identify a United States agent (U.S. agent) for that establishment.
Information about a foreign establishment?s U.S. agent is submitted electronically using the FURLS system and is part of the establishment registration process. Each foreign establishment may designate only one U.S. agent. The foreign establishment may also, but is not required to, designate its U.S. agent as its official correspondent. The foreign establishment should provide the name, address, telephone and fax numbers, and e-mail address of the U.S. agent.
Responsibilities of a U.S. Agent
The U.S. agent must either reside in the U.S. or maintain a place of business in the U.S. The U.S. agent cannot use a post office box as an address. The U.S. agent cannot use just an answering service. They must be available to answer the phone or have an employee available to answer the phone during normal business hours.

The responsibilities of the U.S. agent are limited and include:
  • assisting FDA in communications with the foreign establishment,
  • responding to questions concerning the foreign establishment's devices that are imported or offered for import into the United States,
  • assisting FDA in scheduling inspections of the foreign establishment and
  • if FDA is unable to contact the foreign establishment directly or expeditiously, FDA may provide information or documents to the U.S. agent, and such an action shall be considered to be equivalent to providing the same information or documents to the foreign establishment.
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), or submitting 510(k) Premarket Notifications (21 CFR Part 807, Subpart E)
-
Activity
Register
List
Pay Fee
Initial Importer
YES
807.40(a)
NO
Identify manufacturers
per 807.20(a)(5)
YES
Import agent, broker, and other parties who do not take first possession of a device imported into the United States
NO
NO
NO
 
M

MIREGMGR

#16
is the US authorized representative the same thing as the US agent (...)?
Yes, same thing. "Authorized Representative" is MDD terminology.

(...) is it sufficient that they alert us to complaints or do we need to have another facility based within the US to “Maintain complaint files as required under 21 CFR 820.198”.
You maintain the official complaint files and associated systems. You probably will want to provide your own contact information on the labeling, so that complaints and other communications come directly to you. In this day of cheap international phone calls and essentially free email, there's no reason to direct end users to send communications to your US Agent. It just slows down the communications cycle. The requirement for a US Agent is mostly a legacy formality, at least in regard to well-established device makers.

I am also trying to determine if they should register with FDA
The agent is declared as a part of your registration...not registered on their own, unless they have an addition role such as Initial Importer.

We had planned to send product directly to distributors in the US but are we required to use an initial importer for all shipments and have the shipments distributed by the initial importer to the individual distributors? If the US Agent/Authorized Representative is not the initial importer but we decide to use our OEM’s US facility does the US agent not have to register their facility?
Would it be a possibility to have each distributor be an initial importer (and thus registered) or can there be only a single initial importer.
You do have to have at least one Initial Importer, but that party does not have to take physical possession of the goods or have a facility that is capable of warehousing and inventory. The regulation saying "possession" in my understanding refers to legal possession, i.e. title. Instead you can drop-ship directly to your distributors, as long as the paperwork reflects that legally you are selling to the Initial Importer and they are selling to the distributor(s).

The Initial Importer's role is one of legal responsibility in case FDA has a major problem with you, because FDA cannot impose major penalties on outside-USA companies, other than to bar their products from the US market.

You can have more than one Initial Importer.
 
E

ElmerF

#18
Yes, same thing. "Authorized Representative" is MDD terminology.



You maintain the official complaint files and associated systems. You probably will want to provide your own contact information on the labeling, so that complaints and other communications come directly to you. In this day of cheap international phone calls and essentially free email, there's no reason to direct end users to send communications to your US Agent. It just slows down the communications cycle. The requirement for a US Agent is mostly a legacy formality, at least in regard to well-established device makers.



The agent is declared as a part of your registration...not registered on their own, unless they have an addition role such as Initial Importer.



You do have to have at least one Initial Importer, but that party does not have to take physical possession of the goods or have a facility that is capable of warehousing and inventory. The regulation saying "possession" in my understanding refers to legal possession, i.e. title. Instead you can drop-ship directly to your distributors, as long as the paperwork reflects that legally you are selling to the Initial Importer and they are selling to the distributor(s).

The Initial Importer's role is one of legal responsibility in case FDA has a major problem with you, because FDA cannot impose major penalties on outside-USA companies, other than to bar their products from the US market.

You can have more than one Initial Importer.

MIREGMGR, just one final question. If our facility in Europe is the parent company of the US agent would that mean that a our establishment registration would suffice in the case of the US agent being the initial inporter or would we still need to register separately despite having a US subsidiary?
 
M

MIREGMGR

#19
If the responsible Manufacturer is registered at an outside-USA address, they have to have a US Agent at a USA address; and, there has to be a responsible party, i.e. Initial Importer, registered at a USA address. The fact that the various parties are legally related is irrelevant.

I know of several instances where an outside-USA device maker has a US subsidiary that is their Agent and Initial Importer.
 
E

ElmerF

#20
MIREGMGR, that's great, thanks for the clarification! When you say paperwork, does this just mean the customs paperwork where you identify your initial importer number. Our US agent would not be taking physical possesion of the product nor are they processing the sales, that is being done in our European facility and the sales would be made directly to the distributors (as well as drop shipping to them). Do we need to introduce an additional layer of selling to our US agent/subsidiary and then having them process each sale or is it ok to process the sales order to the distributors but identify/designate our initial importer. Thanks again.
 
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