Registration requirements for custom branded device

#1
Here's our situation:
  • We are a US-based LLC that sells a custom-branded, 501(k) exempt, Class I medical device for the skincare/beauty industry.
  • Our Chinese manufacturer applies our branding & labeling to the device & packaging. They ship the final packaged product directly to a third-party logistics provider's (3PL) warehouse in the US that fulfills orders from our online store.
  • Our Chinese manufacturer is probably private label manufacturing for other companies as well.
  • Our Chinese manufacturer is registered as a Foreign Exporter establishment with the FDA. The device is also listed and associated to their establishment.
My questions:
  1. Do we need to register ourselves with the FDA? If so, as what? An initial importer?
  2. Who should be responsible for the UDI registration/labeling requirements—we or the manufacturer? Especially if the manufacturer does private label manufacturing for other companies/brands.
I've read similar discussions on the board and am left more confused than when I started. Thank you for your help :)
 
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Elsmar Forum Sponsor
#2
I'm particularly confused by the difference between a wholesale distributor and an initial importer.

From 807.3:
(g) Initial importer means any importer who furthers the marketing of a device from a foreign manufacturer to the person who makes the final delivery or sale of the device to the ultimate consumer or user, but does not repackage, or otherwise change the container, wrapper, or labeling of the device or device package.
(t) Wholesale distributor means any person (other than the manufacturer or the initial importer) who distributes a device from the original place of manufacture to the person who makes the final delivery or sale of the device to the ultimate consumer or user.
 

gogreen

Starting to get Involved
#3
"Wholesale distributor" is both broader and more specific than "initial importer." WD is broader because it doesn't only apply to devices from foreign manufacturers; rather, WD includes distributors who purchase from US-based manufacturers. On the other hand, WD is narrower in that it only applies to, well, wholesale distributors, i.e., to distributors who distribute from original place of manufacture to the ultimate consumer. For example, distributing from the original place of manufacture to a reseller is not a WD. Unlike WD, an II is not limited only to distributors--"furthers the marketing" is broader than just distribution. II can be importing from all sorts of foreign establishments, such as relabelers and foreign exporters.

Frankly, understanding the above distinctions are probably less helpful than simply understanding that, if you qualify as an initial importer, you are not a wholesale distributor because of the carveout in the definition of WD. You would follow the II requirements.

Going back to your original post, you may be a relabeler. You stated the manufacturer applies your labeling, which sounds like you are changing the "content of the labeling" and going beyond merely adding your own name. The UDI is part of the label. My understanding is if you supply your own UDI, you are a relabeler. If it is the manufacturer's UDI, and you don't change the content of the labeling, you may not be a relabeler.

In either case, you may also be the initial importer. When you register your establishment, you would select "yes" when asked "Does this facility import medical devices to the United States from outside the U.S.?" If you are also a relabeler, you would then check the box for "Repack or Relabel Medical Device" under "Select all of the following activities that you perform at this facility."
 
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gogreen

Starting to get Involved
#5
Based on your description, we're an initial importer AND a relabeler. Thank you!
Since this conversation, I've actually looked into this further. Having your own UDI (and thus being the labeler (small "L") under UDI), does not automatically make you a Relabeler. In your case, where the manufacturer puts the label on, you can register as the initial importer only.
 
#6
Since this conversation, I've actually looked into this further. Having your own UDI (and thus being the labeler (small "L") under UDI), does not automatically make you a Relabeler. In your case, where the manufacturer puts the label on, you can register as the initial importer only.
What if the manufacturer applies your particular branding (alongside your UDI)? Does that cross the threshold of being a relabeler?
 

monoj mon

Quite Involved in Discussions
#7
Does that cross the threshold of being a relabeler?
NO.

If you are talking about registration and listing, then I think there are some confusions going on around here. According to your definition, in my opinion

1. Your Chinese manufacturing partner is 'NOT' the 'Manufacturer'. They are the 'Contract Manufacturer'.
2. You are 'NOT' the 'Initial Importer'. You are the legal 'Manufacturer' as your brand name is on the device label.
3. Your 3PL is the 'Initial Importer'.
4. Either 'Manufacturer' or 'Contract Manufacturer' can put their UDI on the device labels.
5. Since the Chinese company is putting your brand name on the device label already, I assume you are not changing anything on the original content of the label. Then in this case no one is Re-labeler. If you are changing anything, then Register yourself as 'Manufacturer, Re-labeler'.
6. If your Chinese Partner has listed their facility only as 'Foreign Exporter', then you might run into trouble in the future when the 'FDA' starts looking for the 'Actual manufacturing site'. It has to be clear at the registration and listing database, where the device is physically manufactured and who is the 'legal manufacturer' of the device.

If you are okay with disclosing the information about the Chinese partner then just write on the label,

Manufactured By,
Your Chinese partner name and address

Manufactured For,
Your company name and address
 

gogreen

Starting to get Involved
#8
NO.

If you are talking about registration and listing, then I think there are some confusions going on around here. According to your definition, in my opinion

1. Your Chinese manufacturing partner is 'NOT' the 'Manufacturer'. They are the 'Contract Manufacturer'.
2. You are 'NOT' the 'Initial Importer'. You are the legal 'Manufacturer' as your brand name is on the device label.
3. Your 3PL is the 'Initial Importer'.
4. Either 'Manufacturer' or 'Contract Manufacturer' can put their UDI on the device labels.
5. Since the Chinese company is putting your brand name on the device label already, I assume you are not changing anything on the original content of the label. Then in this case no one is Re-labeler. If you are changing anything, then Register yourself as 'Manufacturer, Re-labeler'.
6. If your Chinese Partner has listed their facility only as 'Foreign Exporter', then you might run into trouble in the future when the 'FDA' starts looking for the 'Actual manufacturing site'. It has to be clear at the registration and listing database, where the device is physically manufactured and who is the 'legal manufacturer' of the device.

If you are okay with disclosing the information about the Chinese partner then just write on the label,

Manufactured By,
Your Chinese partner name and address

Manufactured For,
Your company name and address
I have to disagree with much of what you said. Your opinion just stated that all private label distributors are manufacturers. This is not correct. You may be confusing some concepts in the UDI regulations, 21 CFR Part 830, where the concept of "labeler" is entangled with the concept of "manufacturer," but that does not automatically mean all labelers are manufacturers. Alternatively, you may be referring to the definition of "Manufacture, preparation, propagation, compounding, assembly, or processing" under the Registration and Listing regulations, 21 CFR 807.3(d), which includes Relabeler. At the same time, Initial Importer is also included under 807.3(d), and you point out that as a separate concept, so I can't fully put my finger on where you are getting your conclusion. Either way, having your brand name does not automatically make you a Manufacturer for registration and listing purposes.

With respect to "Contract Manufacturer," can someone be a Contract Manufacturer without being a Manufacturer? Not sure these are mutually exclusive.

With respect to the 3PL, they can be the Initial Importer if they are the Initial Importer, i.e., they meet the definition. In fact, 3PLs are often not the Initial Importer; rather, in Private Label Distributor (PLD) situations, the PLD is the Initial Importer, and only the Initial Importer because, well, again, they meet the definition. 3PLs, for the most part, handle the freight and customs responsibilities. 3PLs are not typically chomping at the bit to register with the FDA and carry out medical device reporting responsibilities. Why would they?

Looking at this from a totally different angle, we can get to these same conclusions without going through all this rigmarole. Who is (actually) manufacturing the finished product and putting the label on? Is Anon's company doing anything to the product or changing the label? Who is importing and furthering the marketing of the device in the United States?

Your solution regarding putting the manufacturer on the label is probably not viable. As you likely know, many PLD's are protective of their manufacturers.
 

monoj mon

Quite Involved in Discussions
#9
Is Anon's company doing anything to the product or changing the label?
We are a US-based LLC that sells a custom-branded
My entire discussion was based on the assumption that Anon's company has provided 'specification' based on the word 'custom-branded'. May be my sentences looked generalizing and incorporating all the 'private label distributors' under the umbrella of 'Manufacturer'. But, you are right, that's not correct.
This assumption has also led me to believe that the 'Chinese partner' has 'contract manufactured' the 'Customized' product using Anon's specification.
They ship the final packaged product directly to a third-party logistics provider's (3PL) warehouse in the US that fulfills orders from our online store
Now, looking again at this sentence, I have realized my answer might not be correct. I beg your pardon for that.
Your solution regarding putting the manufacturer on the label is probably not viable. As you likely know, many PLD's are protective of their manufacturers.
Yes, assuming the Chinese partner contract manufactured based on Anon's spec., that's why I said
If you are okay with disclosing the information about the Chinese partner then just write on the label,
With respect to "Contract Manufacturer," can someone be a Contract Manufacturer without being a Manufacturer? Not sure these are mutually exclusive.
These are, of course, not mutually exclusive. I was giving an example to sort out the registration listing issue, which of course is not the only way to handle. In my first-hand experience, some of our US clients (for whom we 'contract manufacture' the devices) do not physically manufacture the device at all, but they list their facility as 'Manufacturer, Specification Developer'. They provide us the specifications, owns the design files, receives the complaints and initiate corrective actions when needed. I know this contradict with the following definition, but in practical people are practicing this way to clearly state who takes the 'legal responsibility' for the device.
1610677166027.png
Looking at this from a totally different angle, we can get to these same conclusions without going through all this rigmarole. Who is (actually) manufacturing the finished product and putting the label on? Is Anon's company doing anything to the product or changing the label? Who is importing and furthering the marketing of the device in the United States?
Definitely, ultimately they will need to evaluate each of their roles and responsibilities.
 

gogreen

Starting to get Involved
#10
My entire discussion was based on the assumption that Anon's company has provided 'specification' based on the word 'custom-branded'. May be my sentences looked generalizing and incorporating all the 'private label distributors' under the umbrella of 'Manufacturer'. But, you are right, that's not correct.
This assumption has also led me to believe that the 'Chinese partner' has 'contract manufactured' the 'Customized' product using Anon's specification.

Now, looking again at this sentence, I have realized my answer might not be correct. I beg your pardon for that.

Yes, assuming the Chinese partner contract manufactured based on Anon's spec., that's why I said


These are, of course, not mutually exclusive. I was giving an example to sort out the registration listing issue, which of course is not the only way to handle. In my first-hand experience, some of our US clients (for whom we 'contract manufacture' the devices) do not physically manufacture the device at all, but they list their facility as 'Manufacturer, Specification Developer'. They provide us the specifications, owns the design files, receives the complaints and initiate corrective actions when needed. I know this contradict with the following definition, but in practical people are practicing this way to clearly state who takes the 'legal responsibility' for the device.
View attachment 27461

Definitely, ultimately they will need to evaluate each of their roles and responsibilities.
That does make more sense now. Thanks for clarifying. I'd love to hear about your experiences as a contract manufacturer at some point.
 
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