Recently the MFDS has clarified and defined some requirements regarding the need to label with a UDI barcode the Medical Devices to be marketed in the South Korean territory.
Such fulfilment will progressively involve devices of all risk classes and it will determine several obligations for the Licence Holder, that is the registration holder in the territory.
As a matter of fact, in South Korea the registration practice must be presented to the MFDS by an entity established in the South Korean territory who must also carry out devices importation.
The UDI barcode labelling obligation will come into force in 2019 for Class IV devices; in 2020 for Class III devices, in 2021 for Class II devices and in 2022 for Class I devices.
Duly marked devices should obviously be included in a specific database by the License Holder, the Medical Device Information & Technology Assistance Center or MDITAC, which will contain all the information about production, marketing and use for the device traceability in the territory.
For more information:
http://law.go.kr/admRulLsInfoP.do?admRulSeq=2100000073289&vSct=%EC%9D%98%EB%A3%8C%EA%B8%B0%EA%B8%B0
http://law.go.kr/lsInfoP.do?lsiSeq=188095&lsId=009740&chrClsCd=010202&urlMode=lsInfoP&viewCls=lsInfoP&efYd=99990101&vSct=%EC%9D%98%EB%A3%8C%EA%B8%B0%EA%B8%B0#0000
