South Korea - MFDS registration for a Chinese IVD factory

[Cherry Zhu]

Hi everyone!

This is Cherry from a Chinese IVD factory. Nice to meet you here

Recently, parts of our medical devices are going to be registered in South Korea. But the following questions have troubled me for a long time.

• 1. If we choose to delegate a Korean company to register the devices in MFDS (formerly known as KFDA), does it need the authorization from the delegated company to other local distributors to sale products? (That is to say, does this delegated company enjoyed the exclusivity sales of our registered products?)
• 2. Currently, our medical devices don't have any clinical data issued by USA or EU, but the products are on the FDA device listing and are 510k exempt. I wonder if we meet the requirments of registering in South Korea?
• 3. Since the products are on the FDA device listing and are 510k exempt, will the whole registration process will be more easier comparing with the regular process?

It will be much appreciated if anyone could offer me with some help or suggestions

Awaiting your reply!

Many thanks in advance!
Best regards!
Cherry

 

[chk3424]

Hi, Cherry,

I am a consultant medical device in Korea.
Regarding your questions,
1. If my idea is right, "A" company has sold the device under Medical Device Act Korea. And you wants another company(B) in Korea with importing license in spite of the same device.
Basically, it needs the authorization from the delegated company to other local distributors to sale products. For details, it needs new importing business license, GMP (Class II, III, IV) and device approval.

And, "B" can sell the device in Korea without importing license if "B" company purchases the device of "A" with medical device sales license.

2. If there is similar certified device in Korea, it may not need clinical data by equivalece check.

3. For Class I in Korea, it is more easier than Class II, III, IV. But, it cannot be said "510k exempt" will the whole registration process will be more easier comparing with the regular process.

Due to lack of information, I am afraid of replying fully.

If you have any question, please email to [email protected].

 

[ValGal]

Hi @chk3424,

I have a question, too! Thank you for starting the thread, Cherry!

My US company also has an MFDS Class I IVD product but the customer that wants to sell our device wants to know the full formula of our product to report to MFDS. Our formulation is proprietary and we are wanting to submit directly to MFDS to protect our IP. Honestly, they could manufacture the product themselves with the information they are saying is required.

We are being told by the company that this is not possible for us to submit that information directly to MFDS for Class I IVDs in Korea. They are calling it a Regulatory Flexibility Act (RFA) Form

Is that true? If so, do you know where in the law it might say that?

I have read the following link by translating it from Korean in HWP file to English by a webpage (so I don't have a lot of trust).

I can't find where it says our desired submission method is not allowed (or if it is required to go into that level of details).

Thank you for any help that you might be able to provide!!

Best Regards,

ValGal

 

[chk3424]

Hi ValGal,
To apply the IVD to MFDS, it is necessary License holder(the company or person) in Korea as like EU Rep, US agency.
I am not sure exact situation of yours, but anyway, it might not need full formula.
And this is not possible for you to submit that information directly to MFDS for Class I IVDs in Korea.

I hope to be a good information.

Thanks.

 

[ValGal]

Hi ValGal,
To apply the IVD to MFDS, it is necessary License holder(the company or person) in Korea as like EU Rep, US agency.
I am not sure exact situation of yours, but anyway, it might not need full formula.
And this is not possible for you to submit that information directly to MFDS for Class I IVDs in Korea.

I hope to be a good information.

Thanks.

Thank you for your help!