Registration - Korea Food and Drug Administration (KFDA)

[Nissim Shaked]

Hi all,

We are in a process of approving one of our products in the KFDA.

We would like to ask if our registration is depended upon our representative distributor in Korea?

Let us assume that we are already registered and using a distributor name XYZ
Can we change later our distributor in Korea (to ZYX) without loosing our KFDA approval?

Thank you

 

[Ajit Basrur]

Re: Korea registration - KFDA

Hi all,

We are in a process of approving one of our products in the KFDA.

We would like to ask if our registration is depended upon our representative distributor in Korea?

Let us assume that we are already registered and using a distributor name XYZ
Can we change later our distributor in Korea (to ZYX) without loosing our KFDA approval?

Thank you

I am not sure ... can you check with KFDA themselves ?

 

[bio_subbu]

Hi Nissim Shaked

Product registration in Korea requires that the person holding the registration for a medical device must be a legal resident of Korea. For imported products, it is the local distributor who applies for and serves as the legal holder of the medical device registration. You can appoint multiple distributors can hold approvals for your single product, but each distributor must undergo the full product approval process and bear the full cost of the process.

Thanks and Regards
S. Subramaniam

 

[soulfulsynergy]

It depends on what the korean affiliate is registered with...for e.g
if it's only office and not plant that is registered, changing the company name should not require a full audit, just some paperwork to prove that the new korean company you are affiliated with is up to spec to be registered, however if the company you are affiliated with manufactures for you, then you will hve to go through whole process.

I am providing general info here because I do not know the details of your link with Korean company.

 

[Raymond12]

Hi All,

We are thinking about registering our devices into the South Korean market and have come across 'Form 7.'

Does anybody know where I can find this?

Any help would be greatly appreciated.

Thanks.

Ray

 

[Ajit Basrur]

Hi All,

We are thinking about registering our devices into the South Korean market and have come across 'Form 7.'

Does anybody know where I can find this?

Any help would be greatly appreciated.

Thanks.

Ray

I tried to search for Form 7 in the KFDA Website but could not come across. Can you contact them directly ?

 

[Raymond12]

Yeah i have tried to email them but i am still waiting for a responses.

 

[zhang126]

Under Korean laws, a foreign manufacturer without a Korean office may not directly submit a device registration application to the KFDA, but the company may allow its importer to do the registrations. The manufacturer also may hire an independent third party other than distributor based in Korea to make the registrations in its own name.
Later you may use/change any distributor as you like.

 

[sreenu927]

Yes, that's true..U wil get the forms either from your distributor or from the Regulatory Agent.
the same is the case for Taiwan too..
Also find some relevant documents fyi.

Cheers
Sreenu