Two Separate Legal Entities - Manufacturer Vs. Contract Manufacturer

Ronen E

Problem Solver
Staff member
Moderator
#11
If ABC, the "Specification Developer," is importing the devices from XYZ in a foreign country, does this not make ABC an initial importer?
Yes, but it's less relevant. As far as I understand, "Specification Developer" is a sub-category of "Manufacturer", whereas "Importer" / "Initial Distributor" is not. The requirements applicable to Importers are a subset of those applicable to Manufacturers (including SDs).
 
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B

bikeshox

#12
If ABC is not in fact an initial importer, that might solve my problem...

When trying to re-register for 2013, I have ABC listed as a Manufacturer and Initial Importer. In 2013, I'm required to list the products I'm importing, when I attempt to list the products I'm importing from XYZ, DRLM tells me that XYZ is not a Manufacturer....

Does this mean an Initial Importer can only import from a "Manufacturer?"
 
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M

MIREGMGR

#13
IIf I'm a contract manufacturer and i do not distribute the device, does that then make me a manufacturer in DRLM terms?
No. The Manufacturer (or Specification Provider) is the party that hired you to do the Contract Manufacturing and return the products to them in bulk to be distributed by them.

If ABC, the "Specification Developer," is importing the devices from XYZ in a foreign country, does this not make ABC an initial importer?
There is a hierarchy of applicability; every participant in the responsibility chain is accorded the highest responsibility-level that applies, even if additional lower levels of responsibility also apply. The highest level of responsibility is Manufacturer or Specification Developer, so those override Initial Importer even if the latter condition also is true.

In 2013, I'm required to list the products I'm importing, when I attempt to list the products I'm importing from XYZ, DLRM tells me that XYZ is not a Manufacturer....
Yes, it's never been legal to import devices (as opposed to components) from a non-Registered Establishment, but through 2012 FDA had no good mechanism for identifying such situations. With the 2013 rules changes, now they do have such a mechanism, i.e. you can't complete your own registration and listing process until you work with all of your suppliers to get them sorted out as well.

Does this mean an Initial Importer can only import from a "Manufacturer?"
Or a Specification Provider, if they use a Contract Manufacturer...yes.
 
B

bikeshox

#14
Alright Lets try this...

An Initial Importer does not take responsibility for a device, the manufacturer or specification developer does.

The other thing that is throwing me off is how the DRLM defines contract manufacturer. XYZ is the contract manufacturer for ABC. The DRLM has a check box that says "Manufacture and Distribute Medical Device for Another Party (Contract Manufacturer)." However XYZ is does not distribute the device for another party (ABC). Should XYZ still select this option even though they dont distribute the product for another party?
 
M

MIREGMGR

#15
An Initial Importer does not take responsibility for a device, the manufacturer or specification developer does.
Yes, sort of. The FDA sometimes utilizes a 200% responsibility approach, i.e. both the Manufacturer and a contract sterilization provider are fully responsible for sterilization quality. The Initial Importer has some of this 200% responsibility in parallel with the outside-USA Manufacturer in regard to adverse event reporting and post market surveillance.

The other thing that is throwing me off is how the DRLM defines contract manufacturer. XYZ is the contract manufacturer for ABC. The DRLM has a check box that says "Manufacture and Distribute Medical Device for Another Party (Contract Manufacturer)." However XYZ is does not distribute the device for another party (ABC). Should XYZ still select this option even though they dont distribute the product for another party?
The wording in question is per the now-obsolete 2012 rules, under which only distributing contract manufacturers and offshore contract manufacturers had to Register. Under the 2013 rules that went into effect October 1, all contract manufacturers must Register.
 
B

bikeshox

#16
Thanks guys!

My Final Summary..as i see it....and feel free to correct any inaccuracy.

ABC and XYZ are owned by the same parent company. ABC is a Manufacturer/Specification Developer inside the US. XYZ is a Contract Manufacturer located outside the US. XYZ is the contract manufacturer because they make the devices for ABC, to ABC's specification with ABC's labeling and then send the devices to ABC.

-ABC is not an "initial importer" in this case because they are the manufacturer/specification developer taking responsibly for the Class I devices, regardless of the fact that they are importing the devices to the US.

I'm spent.
 
M

MIREGMGR

#17
FYI, as of today the terminology in the Listing module to describe the function of a Contract Manufacturer is:

Manufacture Medical Device for Another Party (Contract Manufacturer)
There is no longer any mention of distribution.
 
B

bikeshox

#19
Hi again! I'm having some more issues with this... We have a shipment stopped in customs, because our US facility is not listed as an initial importer...From the information found in this thread, I determined that our US facility is not an initial importer because we are receiving goods from our foreign facility, whom is the contract manufacturer. Does this sound correct? I'm confused again..
 
M

MIREGMGR

#20
Was the shipment stopped by FDA because they didn't like your PREDICT declaration, or by CBP because they didn't like your device-regulatory-status declaration on your Customs forms?

Historically, the Initial Importer status was created to provide a way to regulate a US distributor that buys and imports finished devices from an outside-US finished device manufacturer. A distributor normally would not have to register, but this would mean that those devices would have no responsible party within the US, within FDA native jurisdiction.

If your PREDICT and Customs forms identify you as a registered Establishment via your Specification Provider status, I would have thought that FDA and Customs would be OK.
 
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