Jan 28, 2020

South Korea’s Ministry of Food and Drug Safety (MFDS) published the final revisions to two regulatory documents pertaining to medical devices. Both draft revisions had been posted by the regulatory body on December 9, 2019 for public consultation and closed on December 30. The final revisions went into effect on January 17, 2020.

Import Requirement Exemptions

MFDS Notice No. 2020-4, Revisions to the Regulations on Exemptions from Import Requirements for Medical Devices, expands the scope of medical devices that are required to receive manufacturing permission and certification. It also clarifies the terminology for medical devices used for research purposes, adjusts the documentation required when applying for exemption of devices for self-use, and permits changes to the stated use of devices. The draft revisions can be found here.

Scarce and Urgently Needed Medical Devices

MFDS Notice No. 2020-5, Enactment of Regulations on the Supply of Scarce and Urgently Needed Medical Devices, delineates the necessary provisions for regulating the supply of said devices. These provisions include demand surveys, establishment and submission of supply plans, application procedures, and stockpiling. The draft revisions are here.

Additional South Korean regulatory resources from Emergo by UL:



  • Timothy Herr