This is a resource page dedicated to South Korea regulations for medical devices:

Regulation documents

Link to all regulations

All documents for the South Korea regulations are in Korean – in order to keep it up to date we will just refer to the government site. A simple translation of the title (second column from the left) will be necessary to figure out which document it is.


Kobridge medical devices registration in South Korea

Kobridge réglementation coréenne

Korea License Holder

Standards and testing in Korea


Korean Medical Devices Regulations

KGMP Guideline English Rev.4

Medical Device Distribution Management Standard

FAQ Korea License Holder

FAQ standards recognition in Korea

Overview of clinical trial regulation in Korea





Linkedin group

Export healthcare to 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.