Medical Device Product Classification in South Korea

[ShRam]

Hi Folks,

I want to know how to find the product codes for the medical devices registered in South Korea. I found one document where the classification rules are explained. I did not get any clarity about our product class from that document. So I want to know if there is any database available like the FDA product classification database?

 

[ASimon]

Hi ShRam, were you ever able to find a classification database? I have been combing the MFDS website with no success finding anything. A lot of third party sources such as Emergo reference a database, but I am not having any luck finding it.

Any guidance on this would be appreciated! I am trying to better understand how my company's products might be classified in accordance with Korean regulations.

 

[ECHO]

Maybe this would help.

Approval Process | Minisry of Food and Drug Safety