Important reminder: the Ministry of Food and Drug Safety MFDS has expanded its list of implants subject to tracking.
The implants traceability requirements were already defined.
Until Dec. 31, 2014 there were only 28 products in that category and now the list expanded to 52.
Among the 24 new products in the list: artificial blood vessels, joints…
Since November 2014, importers have obligation to report on a monthly basis the status of the device.
Templates, examples and presentation are provided by MFDS (in Korea).
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.