inspection of dealers or rental agencies by inspection agencies designated by MFDS Korea

In the past, when purchasing a medical device from medical institutions, the medical device dealers or rental agencies, were required to obtain qualifying inspection from the manufacturer or importer of the said medical devices regarding the manufacturing and quality control standards of the corresponding medical devices before the sale or rental. The regulation relating to the inspection of medical devices have been alleviated hereon to allow the inspection as well by the medical device inspection agencies that Minister of Food and Drug Safety may designate.

From MFDS on Jan. 14, 2014.

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.

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