South Korea IVD Medical Device Classifications

K

kimberley

Hi All, :bigwave:

I was hoping that someone would be able to assist me with this as I seem to have hit a wall!

I am currently trying to determine the classification (and subsequently, the registration requirements for) of IVD medical devices in South Korea.

I have searched (extensively) the KFDA and Emergo sites and cannot seem to ascertain exactly how these devices are classified. I know that IVD regulations in South Korea are changing i.e. IVDs are now being regulated as medical devices in the order of 'high risk' where previously they were regulated as pharmaceuticals. However, I cannot determine if all IVDs are to be considered 'high risk' (class IV) in South Korea, even those which are self-certified in the EU (as per 98/79/EC).

I have emailed the KFDA and have had no respponse.
Any advice would be greatly appreciated!

Thanks so much,

Kimberley
 
K

kimberley

Hi Sreenu,

Thanks for your response.

There is a range of List A, List B and self-certification (as per 98/79/EC) IVDs that we are potentially going to be registering. They are predominantly blood grouping products and reagent red cells.

I am trying to determine if all of the products will be regulated as 'high risk' medical devices (class IV) in South Korea - regardless of their EU classification - and the timelines involved in registering these products. I can get very little information from the KFDA.

I would be grateful for any help!
Thanks,

Kimberley
 

sreenu927

Quite Involved in Discussions
Hi Kimberly,

The classification in Korea is irrespective of EU classification rules.

W.E.F 2012, as per the new regulations, IVDs are classified as high risk Medical devices. There may be transition for the implementation of IVD regulations for an year or so.

There is a separate agency, which is a part of KFDA for IVD Reagents:
IVD Task Force, Medical Device Safety Bureau, KFDA.

Note: This is the information so far obtained from my sources.

Regards,
Sreenu
 
K

kimberley

Thanks again Sreenu!

I have tried to search for the contact details for the IVD Task Force, Medical Device Safety Bureau, KFDA specifically, but so far have only been able to see details for the generic KFDA (have not had any response using this route of communication). Would you be able to provide me with the best contact for this IVD task force? I think it would really help me to get a better understanding of the IVD regulations in South Korea if I could communicate with them directly.

Thank you for all fo your help so far Sreenu, it is much appreciated!

Best regards,

Kimberley
 
C

Cowombat

Hi Kimberly,

The classification in Korea is irrespective of EU classification rules.

W.E.F 2012, as per the new regulations, IVDs are classified as high risk Medical devices. There may be transition for the implementation of IVD regulations for an year or so.

There is a separate agency, which is a part of KFDA for IVD Reagents:
IVD Task Force, Medical Device Safety Bureau, KFDA.

Note: This is the information so far obtained from my sources.

Regards,
Sreenu

To give a bit more granularity, it is not that all IVDs are being classified as high risk devices. Rather, those IVDs that were regulated as manual assay pharmaceuticals under the old laws are being transitioned to the new medical device law. And it is the high risk, class 3 products that are first cab off the rank. The transition target date for these is 31 December 2012. An abridged submission is permitted, so long as approval is issued by that date. After then, the full dossier will be required. Lower risk IVDs will follow over the next year or so.
 
K

kimberley

Hi :)
Thanks for your response.

I believe that approval can take up to 6 months in South Korea so it seems unlikely that we would be able to submit and have approval by 31st December.
We manufacture a variety of IVD devices of different classes and I was trying to ascertain if the EU self-certification IVDs would be relatively quick to register in South Korea initially, before progresssing with the registration of other higher classification IVDs (list A). It seems that EU classification has no impact on the KFDA classification and that classification is more product-specific?
Does seem like quite a complex process!

Thanks
 

sreenu927

Quite Involved in Discussions
Hi Kimberley,

KFDA registration is independent of EU or US approvals.

There is no abridged or simplified submission unlike Singapore where abridged submission (less docs, low fees, less time) are possible with GHTF approvals.

Regards,
Sreenu
 

sreenu927

Quite Involved in Discussions
This is the recent webinar from Emergo on South Korea and Taiwan Medical Device Regulations.

Regards,
Sreenu

Note: I am not related to EMERGO!
 

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