FDA Listing of a Class I Medical Device in USA (Manufactured in China)

[belemsanchez]

I am confused with this issue: until now my company (european) sells a medical device (class I) in USA manufactured in China. It's has a Listing
Number, the device was listing by our company.

But now my company wants to sell in USA this device under its own name, it means that the Chinese company will continue manufacturing the device but it will be labelled as manufactured by our company.

So, in Europe my company will be the manufacturer (because this information appears printed on the label), but is this similar with FDA? I'm not sure if now my company will be or not the manufacturer, according Definitions of Establishment Activities FDA website.


My questions are if the Listing Number of our device change or not, and if we have to explain to FDA who is the real manufacturer (Chinese company).

 

[paulag]

Hi,

you don't have to explain to the FDA who is the "real" manufacturer. Both manufacturer and contract manufacturer of a medical device can, or even have to, register their facility and list the product in their respective role.

 

[belemsanchez]

Thanks Paulag, so does it mean that our chinese outsourcing manufacturer has to register as Manufacturer contract, and again, I'm not sure if our company has to be as Manufacturer, or repackager or relabeler.

Please, could you explain to me with is the diference between repackager ans relabeler? I can't find this information. Our company import the device in bulk and label it as manufactured by our company, doesn't change anyhing, does it mean that we are Manufacturer or repackager or relabeler?


Thanks in advance

 

[belemsanchez]

Thanks, so, does it mean that our Chinese outsourcing manufacturer has to declare as Manufacturer contract?, and regarding our company, we import the devices in bulk and label as manufactured by us, only this step, so, who are we Manufacture, Repackager or Relabeler?

I can't find what's the difference between Repackager and Relabeler.

Thanks in advance

 

[NicoleinFlorida]

My company outsourced the manufacturing in China, too. We are full responsible for this device like post market surveillance, we are the Manufacturer. But the manufacturer in China must be registered as Contract Manufacturer.

 

[belemsanchez]

OK, thanks a lot, because I don't know about this,

 

[Julie O]

The EU makes much of which company is the "legal manufacturer." FDA does not. Note that the FDA process is called ESTABLISHMENT registration, not manufacturer registration. FDA requires quite a lot of different establishments to register, based on their role in the entire process of bringing a device to the US market.

I think this guidance will help you:

https://www.fda.gov/MedicalDevices/...urDevice/RegistrationandListing/ucm053165.htm

 

[paulag]

Right... Establishment Registration first, then they ask which activity for which products. As for the definitions:
Contract Manufacturer - Manufactures a finished device to another establishment's specifications.
Contract Sterilizer - Provides a sterilization service for another establishment's devices.
Foreign Exporter - Exports or offers for export to the United States (U.S.), a device manufactured, prepared, propagated, compounded, or processed in a foreign country, including devices originally manufactured in the United States. A foreign exporter must have an establishment address outside the U.S.
Initial Importer - Any importer who furthers the marketing of a device from a foreign manufacturer to the person who makes 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. The initial importer must have a physical address in the United States staffed by individuals responsible for ensuring the compliance of imported devices with all applicable FDA laws and regulations.
Manufacturer - Makes by chemical, physical, biological, or other procedures, any article that meets the definition of "device" in Section 201(h) of the Federal Food, Drug, and Cosmetic (FD&C) Act.
Repackager - Packages finished devices from bulk or repackages devices made by a manufacturer into different containers (excluding shipping containers).
Relabeler - Changes the content of the labeling from that supplied from the original manufacturer for distribution under the establishment's own name. A relabeler does not include establishments that do not change the original labeling but merely add their own name.
Remanufacturer - Any person who processes, conditions, renovates, repackages, restores, or does any other act to a finished device that significantly changes the finished device's performance or safety specifications, or intended use.
Reprocessor of Single Use Device - Performs remanufacturing operations on a single use device.
Specification Developer - Develops specifications for a device that is distributed under the establishment's own name but performs no manufacturing. This includes establishments that, in addition to developing specifications, also arrange for the manufacturing of devices labeled with another establishment’s name by a contract manufacturer.
U. S. manufacturer of export only devices - Manufactures medical devices that are not sold in the U.S. and are manufactured solely for export to foreign countries

 

[rwend07]

In this situation, it sounds to me like you would be a specification developer and your Chinese manufacturer would be a contract manufacturer. Either way, you both are responsible for having cGMP in place.

 

[Julie O]

Right... Establishment Registration first, then they ask which activity for which products.

I wonder if this might be a source of confusion for companies outside the US.

Establishments sometimes identify multiple activities in their registration, because they sometimes carry out multiple activities at the same establishment. If you are not familiar with the US regulatory scheme, this may be easily confused with registering multiple establishments Some companies may wonder if they are supposed to list all the establishments involved in the manufacture of their product. But the FDA way is for each establishment involved in the manufacture of the device to register itself.