Notification Detail
"Medical Device Act Enforcement Regulation" (41 page(s), in Korean)
Reference: G/TBT/N/KOR/811
Date of arrival: 2019 February 15 - Final date for comments:
2019 April 16
Description
Following the amendment to the Medical Device Act on 11 December 2018, its subordinate legislation, "Medical Device Act Enforcement Regulation", has been amended to include the following : a. foreign bodies that should be reported, time limit and procedures for report, actions taken to the reported, etc. b. preparations for and scope of on-site inspection in foreign medical devices establishments, actions applied to medical devices with potential risks, procedures to lift the imposed restrictions, etc.Objectives
OtherProtection of Human Health or Safety
Fields of Activity
Medical equipmentFull notification form text
Full text of the announced text or any other relevant text
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