• June 12, 2018
  • WTO

Korea Amendment of "Medical Device Act Enforcement Regulation"



The proposed amendment aims at 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.

Draft Text 1 is available for download in the following languages: Korean

                   

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