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