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Seeking Medical Device Registration Process in Korea

Roland chung

Trusted Information Resource
#1
Hello folks,

I am seeking medical device registration process in Korea. I can not find any useful stuff in KFDA website. In addition, I was told that CB certificate (not CE) is a must if we want to sell our product in the Korea market. Is this true?

Thanks in advance.
Roland
 
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Marc

Fully vaccinated are you?
Staff member
Admin
#3
Another quick "Bump". My Thanks in advance to anyone who can help with this one.
 

PearlKetchup

Starting to get Involved
#5
Hello, I have just joined a medical device startup and we are going through this process to bring two of our devices to the Korean market. We are already part way through so I am playing catch up with the regulations and requirements. This Emergo whitepaper may be of help to others. Cheers to the cove!
 

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