ABSTRACT
According to South Korea’s regulation, medical devices are classified as medical instruments, medical supplies, dental materials, and
defibrillator, medical laserIV High Prosthetics heart valve, implantable cardiac pacemaker, heparin-coated catheter Source: KFDA Notice (December 2010). 31.1.4 Detail of Key RegulatorThe Ministry of Health and Welfare (MOHW) is the primary healthcare agency in Korea and regulates the Law and Enforcement decrees. However, the KFDA, an agency under the MOHW, independently regulates all medical devices according to the Medical Device Act; only when the KFDA asks the legislation to fulfil its mission, the agreement with the MOHW is required. Details can be found at KFDA home page: https://www.kfda.go.kr/eng/index.do?nMenuCode=12.
