High Risk Medical Device Type Testing in Korea (Requirements)

K

kgwoz

#1
Hi everyone,

Is there a typical number of samples that are required for type testing in Korea (high-risk device)? My client is trying to plan a build and needs to know how many devices to make for the type testing?

Thanks,
Karen
 
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Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#3
Another quick "Bump" in case someone here can help with this one. My Thanks in advance!
 
T

Tom Sha

#4
Hi,
We conducted several times of Type Testing previously in Korea. Our products were high-risk device too. The numbers of testing samples were not fixed which were from 9-35.
 

Michael Malis

Quite Involved in Discussions
#5
Hi everyone,

Is there a typical number of samples that are required for type testing in Korea (high-risk device)? My client is trying to plan a build and needs to know how many devices to make for the type testing?

Thanks,
Karen
Karen,

Because understanding of device criticality varies throughout the world, my advice is to confirm with KFDA. In my prior life, they were inconsistent with decisions and recommendations based on what they consider really critical.

Regards,
Michael
 
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