South Korea Medical Device Regulations

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Major Regulations
Document Number Published Language
Download Medical Devices Act Act No.13116 2015 English
Download Regulations for Re-evaluation of Medical Device MFDS Notification No. 2013-67 04/2013 English
Download Regulation for Medical Device Approval, Notification, Review with attached table MFDS Notification No. 2019-13 02/2019 Korean
Download Medical Devices Act Act No.13116 2015 Korean
Download Regulations for Reviewing Technical Document, etc. of Medical Device - Attached Table KR-001 - Korean
Download Regulations for Prior Review of Medical Device Advertisement with attached table MFDS Notification No. 2013-189 06/2013 Korean
Download Regulations for Management of Safety Information on Medical Devices including Adverse Event Reporting, etc.with attached table MFDS Notification No. 2013-62 04/2013 Korean
Download Regulations for Re-examination of Medical Device with attached table MFDS Notification No. 2013-66 04/2013 Korean
Download Regulations for Reviewing Technical Document, etc. of Medical Device KFDA Notification No. 2010-42 6/2010 Korean
Download Enforcement Decree of the Medical Devices Act - Attached Table Presidential Decree No. 24480 03/2013 Korean
Download Enforcement regulation of the Medical Device Act with attached table Ministerial Decree No. 1016 03/2013 Korean
Download KGMP quality management system compliance with attached table MFDS Notification No. 2013-219 09/2013 Korean
Specific Guidance Documents
Document Number Published Language
Download Regulations for Product Classifications of Medical Devices and Class by Product MFDS Notification No. 2016-4 02/2016 Korean
Download Regulations for Performance Report on Production, Export, Import and Refurbishing of Medical Device - Attached Table KR-002 Korean
Download Regulations on Approving Clinical Investigation Plan for Medical Device MFDS Notification No. 2013-53 04/2013 Korean
Download Regulations for Management of Clinical Trial for Medical Device MFDS Notification No. 2013-211 08/2013 Korean
Download Designation of Medical Device Subject to Tracking MFDS Notification No. 2013-169 4/2013 Korean
Download Regulations for Designation of Technical Document Review Organization for Medical Device MFDS Notification No. 2013-212 08/2013 Korean
Download Regulations for Performance Report on Production, Export, Import and Refurbishing of Medical Device MFDS Notification No. 2013-63 04/2013 Korean
Download Detailed operational GMP guideline for foreign manufacturers of imported medical devices Rev. 1 2013 Korean
Forms and Applications
Document Number Published Language
Download Regulations for Prior Review of Medical Device Advertisement - Attached Form KR-004 Korean
Download Application for Designation of an Orphan Device - Attached Form KR-003 04/2013 Korean
Download Application for Designation of an Orphan Device MFDS Notification No. 2013-71 04/2013 Korean