Korea License Holder for a Medical Device

[shimonv]

Hi Everyone,
I have two questions that perhaps one of you might be able to help clarify:

1. Is it possible to do the registration through an RA consultant and a separate marketing agreement with a third part distributor. In such a scheme a distributor replacement would not result in a regulatory notification of some sort. correct?
2. Can anyone estimate how long it takes to disconnect and replace a distributor from a Korean license? Is this a variation application?

Thanks,
Shimon

 

[Ronen E]

http://www.mfds.go.kr/eng/index.do?searchKeyCode=125&nMenuCode=46

 

[sreenu927]

Yes. You can appoint a consulting firm to hold your licenses, who will act as your importer as well. You can then appoint a distributor who can sell your products.
For existing distributor licenses, there is no need to notify to MFDS on your distributor/license holder change/disconnect the current one.
(just don't sell products to him).
It allows to have multiple registration of same product.

But make sure with your new license holder-cum-importer, your Korean labeling has the new importer name & address and new permit number (registration approval).

Regards
Sreenu

 

[shimonv]

Thanks Streenu!
And if I the distributor is the license holder and we need to replace him is this like a new submission or a smaller license ammendment?


Shimon

 

[Access2hc]

That is correct shimonv and it is a very expensive and time consuming exercise. not just for Korea but for some of the other regulated countries as well.

to find the Korea RA consultant to do it, as Sreenu927 mentioned, it's imperative to due diligence their credibility before jumping in and commmitting.

hope it helps

Cheers,
Ee Bin
@Access2HC