Background
Recently Korean Ministry of Food and Drug Safety (MFDS previously called KFDA) published its quality management standard for distributors operating in South Korea. Is your distributor 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.
We prepared a guide to keep you informed and you can download it by clicking here:
Medical Device Distribution Management Standard
The original publication can be found here.
If you wish to sell in South Korea you can contact us for a preliminary discussion. See also our services for the registration of medical devices in South Korea.
