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?
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.
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?
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.
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