Recently the Korean government has passed an amendment bill that would force the Korea License Holder (KLH) to renew all their Medical Device License(s) every 5 years.
As of 2018, it was surveyed that the total number of device licenses issued to KLHs was 91,809 whereas no manufacturing/importation records were present for 36,680 cases (40%).
Once the amendment takes effect, to continue the product distribution, device license renewal will need to be completed before the expiry date.
In the case where the MFDS will determine the product having critical safety and efficacy issues or a KLH will not submit sufficient documents for license renewal, the device license cannot be renewed.