Question about who should register the foreign medical device establishment

L

luloo117117

#1
Hello,

Although below table on the FDA website demonstrates who should register. BUT still have questions about the following specific situations.

Situation#1: Company A is out of USA. Company A makes the products under its own name (such as products are manufactured by A, and with A's address on labeling). Company A sells and exports these products to USA's importer C.

Question: who should register and what Activity (from FDA table) should be chosen?

Situation#2: Both Company A and B are out of USA. Company A makes the products (under Company A's name, such as products are manufactured by A, and with A's address on labeling) and sells to Company B. Company B sells and exports these products to USA's importer C.

Question: who should register and what Activity (from FDA table) should be chosen?


Situation#3: Both Company A and B are out of USA. Company A makes the products (under Company B's name, such as products are manufactured by B, and with B's address on labeling) and sells to Company B. Company B sells and exports these products to USA's importer C.

Question: who should register and what Activity (from FDA table) should be chosen?



FDA table
Foreign Establishments
Activity
Register
List
Pay Fee
Foreign ManufacturersYES
807.40(a)YES
807.40(a)YES
Foreign Exporter of devices located in a foreign countryYES
807.40 (a)YES
807.40 (a)NO
Contract Manufacturer whose device is shipped to U.S. by the contract manufacturer or by any other firmYES
807.40(a)YES
807.40(a)YES
Contract Sterilizer whose sterilized device is shipped to U.S. by the sterilizer or by any other firm.YES
807.40(a)YES
807.40(a)YES
Reprocessor of Single-use DeviceYES
807.20(a)YES
807.20(a)YES
Custom Device ManufacturersYES
807.20(a)(2)YES
807.20(a)(2)YES
Relabeler or RepackagerYES
807.20(a)(3)YES
807.20(a)(3)NO
Kit AssemblerYES
807.20(a)YES
807.20(a)YES
Device Being Investigated under IDENO
812.1 (a) NO
812.1(a),
807.40(c)NO
Specification Developer YESYESYESRemanufacturerYESYESNOManufacturer of components that are distributed only to a finished device manufacturerNO
807.65(a)NONOMaintains compliant files as required under 21 CFR 820.198
(Note: register as a manufacturer if physical manufacturing taking place at site, otherwise register as a specification developer)YESYESYES


Thanks
 
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L

Laura Halper

#4
Hi Luloo,
Here is my take on it:

Situation #1: Company A must register (foreign manufacturer) and Company C must register (initial distributor/importer)

Situation #2: Same as Situation #1. Company B does not need to register if they do not reprocess, repackage or relabel.

Situation #3: Company A must register (foreign contract manufacturer), Company B must register (foreign manufacturer), and Company C must register (initial distributor/importer).

Regards,
Laura
 
L

luloo117117

#5
Thanks for your explainations. But there is still some confusion.

The definition of manufacturer is who distributes the products into USA market under its own name.

So if the company A is just make the product but the product never under its name (actually under C's name), why A is still called manufacturer?





Hi Luloo,
Here is my take on it:

Situation #1: Company A must register (foreign manufacturer) and Company C must register (initial distributor/importer)

Situation #2: Same as Situation #1. Company B does not need to register if they do not reprocess, repackage or relabel.

Situation #3: Company A must register (foreign contract manufacturer), Company B must register (foreign manufacturer), and Company C must register (initial distributor/importer).

Regards,
Laura
 
L

Laura Halper

#6
I'm sorry, but now I am confused, too!

Your situation #1 and #2 said the product is made under Company A's name.

Your situation #3 said the product is made under Company B's name.


Please describe the situation where "company A is just make the product but the product never under its name (actually under C's name) ". Once I understand the situation better, I'll try to answer again.

Thanks,
Laura
 
L

luloo117117

#7
Sorry. Please forget about the post #5 I posted. There is some typo.

I agree with your conclusion on situation #1 and #3, but I have question on #2.

You said "Situation #2: Same as Situation #1. Company B does not need to register if they do not reprocess, repackage or relabel." But why B can not be the "Foreign Exporter"?

Thanks


I'm sorry, but now I am confused, too!

Your situation #1 and #2 said the product is made under Company A's name.

Your situation #3 said the product is made under Company B's name.


Please describe the situation where "company A is just make the product but the product never under its name (actually under C's name) ". Once I understand the situation better, I'll try to answer again.

Thanks,
Laura
 
G

gar4guv

#8
for #3, i don't believe company A has to register unless it distributes the products commercially or is involved with specification development. if they are only doing contract manufacturing and sending the product back to company B, then i think they can go without registering.


21CFR807.20(c) Registration and listing requirements shall not pertain to any person who:
(1) Manufacturers devices for another party who both initiated the specifications and commercially distributes the device;
 
A

aoldendo

#9
Hi luloo117117 et al,

I hope you don't mind luloo but I would like to ask a similar question to yours based on the following caveat..

Situation Z: Company A is outside of USA. Company A makes the products under its own name (such as products are manufactured by A, and with A's address on labeling) and sells them too outside of the US. Additionally, company A sells and exports these products to USA's importer C. Prior to company A's exporting, Importer C asks Company A to change some specifications ever so slightly and gets a 510(k) on Company A's device.

Question: who should register and what Activity (from FDA table) should be chosen?

My initial thoughts: Company A is an exporter and contract manufacturer
Importer C is an importer and spec developer.

Is this correct?

Thanks..
 
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