Medical Device Distribution Quality Management in South Korea

edgar123

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Recently Korean Ministry of Food and Drug Safety (MFDS previously called KFDA) published its quality management standard for distributors operating in South Korea. Are distributors ready ?
After strengthening its regulation for license holders and require them to appoint a dedicated Quality Manager (effective since July 2014), MFDS is now regulating the distribution more precisely.
This new regulation about medical device distribution will take effect starting from Jan. 1st of next year.

The original publication can be found here (in Korean).
 
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