Two Separate Legal Entities - Manufacturer Vs. Contract Manufacturer

B

bikeshox

#1
Hello all and thanks in advance for any advice.

We have two separate legal entities doing business under the same name, ABC is located in the US and XYZ is located outside of the US. For a particular line of products, ABC has developed the specifications for XYZ. XYZ manufactures the product and exports the product to ABC in the US, where ABC then distributes the product with their own name/address listed on the product (no other operations are performed on the product).

My questions are?

Does this make XYZ a contract manufacturer? According to the FDA?s website a contract manufacturer ?Manufactures a finished device to another establishment's specifications.? However when I go to re-register on the DRLM site the check box for contract manufacturer states, ?Manufacture and Distribute Medical Device for Another Party.? According to the first Definition XZY is a contract manufacturer, but according to the second definition it is not. Am I missing something here?
 
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B

bikeshox

#2
Re: Manufacturer Vs. Contract Manufacturer

Maybe I should mention that when the US company imports the product, they take full responsibility of the product.
 

somashekar

Staff member
Super Moderator
#3
Re: Manufacturer Vs. Contract Manufacturer

Hello all and thanks in advance for any advice.

We have two separate legal entities doing business under the same name, ABC is located in the US and XYZ is located outside of the US. For a particular line of products, ABC has developed the specifications for XYZ. XYZ manufactures the product and exports the product to ABC in the US, where ABC then distributes the product with their own name/address listed on the product (no other operations are performed on the product).

My questions are?

Does this make XYZ a contract manufacturer? According to the FDA?s website a contract manufacturer ?Manufactures a finished device to another establishment's specifications.? However when I go to re-register on the DRLM site the check box for contract manufacturer states, ?Manufacture and Distribute Medical Device for Another Party.? According to the first Definition XZY is a contract manufacturer, but according to the second definition it is not. Am I missing something here?
Perhaps THIS thread will get you some better insight
 
B

bikeshox

#5
By reading through the other thread, I do believe XYZ (in the example above) is the contract manufacturer.

However...
While updating my registration for this year, I'm having trouble with the new system. I have Company ABC listed as an initial importer, so the DRLM then asks me where my imported products come from. I select XYZ for the particular products, but it wont allow me to use a contract manufacturer as an exporter.... Am I missing something?

Again, I find it odd that the DRLM site, lists a contract manufacturer as ?Manufacture and Distribute Medical Device for Another Party.?

Maybe I'm wrong and ABC is not an Initial importer?
 
M

MIREGMGR

#6
Does this make XYZ a contract manufacturer? According to the FDA?s website a contract manufacturer ?Manufactures a finished device to another establishment's specifications.? However when I go to re-register on the DRLM site the check box for contract manufacturer states, ?Manufacture and Distribute Medical Device for Another Party.? According to the first Definition XZY is a contract manufacturer, but according to the second definition it is not. Am I missing something here?
The old DRLM definition was overly brief, maybe because of space limitations. For a long time, it was the rule that a within-USA maker of finished devices to another company's specs only had to Register and List if they distributed the finished device to end users on behalf of the customer; but, an outside-USA maker of finished devices had to Register and List irrespective of distribution.

Note however that this changed as of the start of FDA regulatory year 2013 on October 1. Now all Contract Manufacturers have to Register and List, no matter where they are and irrespective of distribution.
 
M

MIREGMGR

#7
By reading through the other thread, I do believe XYZ (in the example above) is the contract manufacturer.

However...
While updating my registration for this year, I'm having trouble with the new system. I have Company ABC listed as an initial importer, so the DRLM then asks me where my imported products come from. I select XYZ for the particular products, but it wont allow me to use a contract manufacturer as an exporter.... Am I missing something?

Again, I find it odd that the DRLM site, lists a contract manufacturer as “Manufacture and Distribute Medical Device for Another Party.”

Maybe I'm wrong and ABC is not an Initial importer?
The DRLM site hasn't been updated fully yet for the new regulations, I don't think.

As to the Initial Importer question: a declaration that a Contract Manufacturer is involved, inherently requires that there be a primary regulatorily responsible party...either a Manufacturer or a Specification Provider, for whom the Contract Manufacturer works.

An Initial Importer imports finished medical devices from an outside-USA Manufacturer, not from a Contract Manufacturer. (Or conceivably imports from an outside-USA Specification Provider, if that Specification Provider uses a third party Contract Manufacturer...and in this latter case, the Specification Provider would be reported as the responsible device maker, even if they have their Contract Manufacturer do their distribution so that the Initial Importer actually receives shipments from the Contract Manufacturer.)

Every medical device must have one party that has primary regulatory responsibility. That party is the Manufacturer or the Specification Provider.
 

Ronen E

Problem Solver
Staff member
Moderator
#8
The DRLM site hasn't been updated fully yet for the new regulations, I don't think.

As to the Initial Importer question: a declaration that a Contract Manufacturer is involved, inherently requires that there be a primary regulatorily responsible party...either a Manufacturer or a Specification Provider, for whom the Contract Manufacturer works.

An Initial Importer imports finished medical devices from an outside-USA Manufacturer, not from a Contract Manufacturer. (Or conceivably imports from an outside-USA Specification Provider, if that Specification Provider uses a third party Contract Manufacturer...and in this latter case, the Specification Provider would be reported as the responsible device maker, even if they have their Contract Manufacturer do their distribution so that the Initial Importer actually receives shipments from the Contract Manufacturer.)

Every medical device must have one party that has primary regulatory responsibility. That party is the Manufacturer or the Specification Provider.
:yes:

I would say that ABC should register as a Specification Developer (which is in fact a category of Manufacturer) rather than as an Importer / Initial Distributor.
 
B

bikeshox

#9
The DRLM site hasn't been updated fully yet for the new regulations, I don't think.
I emailed the FDA to ask about the definition on DRLM vs, the standard "Contract Manufacturer" definition. They said:

"Both are correct. Some contract manufacturers also distribute the devices for the specifications developer and some return the devices to the specifications developer."

Which doesn't make any sense to me. If I'm a contract manufacturer and i do not distribute the device, does that then make me a manufacturer in DRLM terms?
 
B

bikeshox

#10
:yes:

I would say that ABC should register as a Specification Developer (which is in fact a category of Manufacturer) rather than as an Importer / Initial Distributor.
If ABC, the "Specification Developer," is importing the devices from XYZ in a foreign country, does this not make ABC an initial importer?
 
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