South Korea Medical Device Regulations

All documents listed below are current as of 1 January 2014, but the MFDS reviews and updates these documents frequently throughout the year. For the most current copies of the regulations please refer to the government website. All PDFs will be in Korean. Please contact us with any questions.

Major Regulations

DocumentLanguageNumberPublished
Enforcement Decree of the Medical Devices Act - Attached Table ko Presidential Decree No. 2448003/2013
Enforcement regulation of the Medical Device Act with attached tableko Ministerial Decree No. 1016 03/2013
KGMP quality management system compliance with attached tableko MFDS Notification No. 2013-21909/2013
Medical Devices Acten ko Act No.131162015
Regulation for Medical Device Approval, Notification, Review with attached tableko MFDS Notification No. 2013-21208/2013
Regulations for Management of Safety Information on Medical Devices including Adverse Event Reporting, etc.with attached tableko MFDS Notification No. 2013-6204/2013
Regulations for Prior Review of Medical Device Advertisement with attached tableko MFDS Notification No. 2013-18906/2013
Regulations for Re-evaluation of Medical Deviceen MFDS Notification No. 2013-6704/2013
Regulations for Re-examination of Medical Device with attached tableko MFDS Notification No. 2013-6604/2013
Regulations for Reviewing Technical Document, etc. of Medical Device - Attached Tableko KR-001-
Regulations for Reviewing Technical Document, etc. of Medical Device ko KFDA Notification No. 2010-426/2010

Specific Guidance Documents

DocumentLanguageNumberPublished
Designation of Medical Device Subject to Tracking ko MFDS Notification No. 2013-1694/2013
Detailed operational GMP guideline for foreign manufacturers of imported medical devices ko Rev. 12013
Regulations for Designation of Technical Document Review Organization for Medical Device ko MFDS Notification No. 2013-21208/2013
Regulations for Management of Clinical Trial for Medical Device ko MFDS Notification No. 2013-21108/2013
Regulations for Performance Report on Production, Export, Import and Refurbishing of Medical Device - Attached Tableko KR-00209/2014
Regulations for Performance Report on Production, Export, Import and Refurbishing of Medical Deviceko MFDS Notification No. 2013-6304/2013
Regulations for Product Classifications of Medical Devices and Class by Productko MFDS Notification No. 2016-402/2016
Regulations on Approving Clinical Investigation Plan for Medical Deviceko MFDS Notification No. 2013-5304/2013

Forms and Applications

DocumentLanguageNumberPublished
Application for Designation of an Orphan Device - Attached Formko KR-00304/2013
Application for Designation of an Orphan Deviceko MFDS Notification No. 2013-7104/2013
Regulations for Prior Review of Medical Device Advertisement - Attached Formko KR-00409/2014