South Korea Medical Device Regulations

The South Korean 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


Document	Language	Number	Published
Enforcement Decree of the Medical Devices Act - Attached Table	ko	Presidential Decree No. 24480	03/2013
Enforcement regulation of the Medical Device Act with attached table	ko	Ministerial Decree No. 1016	03/2013
KGMP quality management system compliance with attached table	ko	MFDS Notification No. 2013-219	09/2013
Medical Devices Act	en ko	Act No.13116	2015
Regulation for Medical Device Approval, Notification, Review with attached table	ko	MFDS Notification No. 2013-212	08/2013
Regulations for Management of Safety Information on Medical Devices including Adverse Event Reporting, etc.with attached table	ko	MFDS Notification No. 2013-62	04/2013
Regulations for Prior Review of Medical Device Advertisement with attached table	ko	MFDS Notification No. 2013-189	06/2013
Regulations for Re-evaluation of Medical Device	en	MFDS Notification No. 2013-67	04/2013
Regulations for Re-examination of Medical Device with attached table	ko	MFDS Notification No. 2013-66	04/2013
Regulations for Reviewing Technical Document, etc. of Medical Device - Attached Table	ko	KR-001	-
Regulations for Reviewing Technical Document, etc. of Medical Device	ko	KFDA Notification No. 2010-42	6/2010

Specific Guidance Documents


Document	Language	Number	Published
Designation of Medical Device Subject to Tracking	ko	MFDS Notification No. 2013-169	4/2013
Detailed operational GMP guideline for foreign manufacturers of imported medical devices	ko	Rev. 1	2013
Regulations for Designation of Technical Document Review Organization for Medical Device	ko	MFDS Notification No. 2013-212	08/2013
Regulations for Management of Clinical Trial for Medical Device	ko	MFDS Notification No. 2013-211	08/2013
Regulations for Performance Report on Production, Export, Import and Refurbishing of Medical Device - Attached Table	ko	KR-002	09/2014
Regulations for Performance Report on Production, Export, Import and Refurbishing of Medical Device	ko	MFDS Notification No. 2013-63	04/2013
Regulations for Product Classifications of Medical Devices and Class by Product	ko	MFDS Notification No. 2016-4	02/2016
Regulations on Approving Clinical Investigation Plan for Medical Device	ko	MFDS Notification No. 2013-53	04/2013

Forms and Applications


Document	Language	Number	Published
Application for Designation of an Orphan Device - Attached Form	ko	KR-003	04/2013
Application for Designation of an Orphan Device	ko	MFDS Notification No. 2013-71	04/2013
Regulations for Prior Review of Medical Device Advertisement - Attached Form	ko	KR-004	09/2014

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