FDA - Change of Manufacturings Site to Contract Manufacturer in China

N

NoaWeber

#1
Hello all,
We are a manufacturer of Medical devices located outside of the US (foreign manufacturer). Currently our manufacturing site is located at the same building of our company management.
We have an FDA establishment registration and listing.
We're about to move our manufacturing to a contract manufacturer in China. All manufacturing will be according to our design and specifications.
The factory we're going to manufacture at, has FDA registration and listing itself as well.
What is the correct and simplest process of updating the FDA on passing the manufacturing to that specific contract manufacturer?
Anything else that should be done?
Thanks for your assistance.
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Re: FDA - change of manufacturings site to contract manufacturer in China - how to do

Hi Noa,

In a nutshell: As soon as you move your production you need to change your listings to show that you are a Specification Developer. Then your Chinese Contract Manufacturer needs to list your devices (the same devices) as a Contract Manufacturer. Additionally, all your relevant processes and documentation need to be reviewed and updated to reflect the change. You also need to observe your current Change Control procedure.

Any further questions, please feel welcome to email / Skype me.

Cheers,
Ronen.
 
N

NoaWeber

#3
Re: FDA - change of manufacturings site to contract manufacturer in China - how to do

Hi Ronen,

Long time....

Were there any updates to the procedure you mentioned in your reply or the procedure remain the same?

Noa.
 

Ronen E

Problem Solver
Staff member
Moderator
#4
Re: FDA - change of manufacturings site to contract manufacturer in China - how to do

Hi Ronen,

Long time....

Were there any updates to the procedure you mentioned in your reply or the procedure remain the same?

Noa.
Hi Noa,

As much as I know everything I noted above is still current.

Cheers,
Ronen.
 
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