KOR/774
WTO/TBT
KR South Korea
  • 11 - Health care technology
2018-08-06
2018-06-08

Medical Devices

Amendment of "Medical Device Act Enforcement Regulation" (13 page(s), in Korean)

a. Clarifying scope of adverse events that should be reported to the Minister of Food and Drug Safety; and b. Setting up detailed provisions specific to the ones that should be reported to the Minister of Food and Drug Safety when a manufacturer or an importer, etc.  distributes medical devices to medical institutions, etc.