KR Corée du Sud
  • 11 - Technologies de la santé

Medical Devices

"Medical Device Act Enforcement Regulation" (41 page(s), in Korean)

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.