FDA facility Registration

sherley13

Involved In Discussions
#1
Dear Sir,

This is with regards to FDA facility registration the question is : “X” company is located in Asian continent and it is a trading company and this “X” company wants to register their facility in USFDA. The “X” company is buying the products from “Y” company (Medical device manufacturer ) and wants to sell their products in US markets. This “Y” company is partnership with “X” company.

Note : Y - company does not wants to register with USFDA alone.

US agent can do USFDA Registration of the “X” company?

Please advise.:confused:
 
R

regork

#2
Here is my opinion based on experience w/ Foreign MD manufacturers and FDA enforcement.

1. If company X is the manufacturer of a finished medical device or accessory that meets the FDA definition of a medical device and makes it available for sale in the US, they need to register with the FDA as a manufacturing establishment.

2. If company Y wants to be the device manufacturer, it would need to complete device premarket, comply w/ QSR, comply w/ device labeling. Taking total responsibility for the design, development, manufacturing, and support of the device.

3. in addition to the US agent, you need to think about how your devices will be imported into the US. Is company Y going to sell and ship directly to US customers or will company Y ship product to a US distributor who in turn sells to US customers?
 

sherley13

Involved In Discussions
#3
Thank you for answer to my questions. Again Here is my question….
As per your item 1 to 3 :-

Item #1. Currently the X company involve only in packaging activity and they are going to comply with 21 CFR part 820 ( QSR) requirements and this X wants to sale Y company products in US. This X wants to do FDA registration. (Note : X is also meets the ISO13485 requirements)

Item # 2. The Y makes the device and Y comply with the ISO13485 and CE requirements of the that product. They are taking the responsibility of design, development and mfg of the device. Y -does not want register with FDA.

Item # 3. Y does not want do any business with US region. Y - They are only dealing with X company. The X - company wants to sale Y company product in US….. and X company wants to file 510K on the product.

As we are US agent :

X- company will take responsibility of Packaging activities of the Y company device. Can we do X company FDA registration ???

Please advise.

Thank you.
Sherley13
 
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