• December 13, 2017
  • WTO

Korea - Amendment of Medical Device Act Enforcement Regulation

Expanding scope of exemptions from manufacturing and import business licenses, clarifying scope of medical device advertisements, overhauling recall procedures for medical devices, establishing the management standards for integrated information of medical devices and Integrated Medical Device Information System (IMDIS) including UDI (Unique Device Identification), rationalizing GSP (Good Supply Practice).

Final date for comments: 09 February 2018.

Link to WTO notification

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