South Korea Regulatory Framework Medical Device registration

South Korean Medical devices regulation basics

Here below are reported some of the most relevant guidance for Medical Device Registration in South Korean market:

Major Regulations

Regulation	Year
Enforcement Decree of the Medical Devices Act – Attached Table	2013
Enforcement regulation of the Medical Device Act with attached table	2013
KGMP quality management system compliance with attached table	2013
Medical Devices Act (english)	2015
Medical Devices Act (korean)	2015
Regulation for Medical Device Approval, Notification, Review with attached table	2019
Regulations for Management of Safety Information on Medical Devices including Adverse Event Reporting, etc.with attached table	2013
Regulations for Prior Review of Medical Device Advertisement with attached table	2013
Regulations for Re-evaluation of Medical Device	2013
Regulations for Re-examination of Medical Device with attached table	2013
Regulations for Reviewing Technical Document, etc. of Medical Device – Attached Table	Undated
Regulations for Reviewing Technical Document, etc. of Medical Device	2010

Specific Guidance Documents

Document	Year
Designation of Medical Device Subject to Tracking	2013
Detailed operational GMP guideline for foreign manufacturers of imported medical devices	2013
Regulations for Designation of Technical Document Review Organization for Medical Device	2013
Regulations for Management of Clinical Trial for Medical Device	2013
Regulations for Performance Report on Production, Export, Import and Refurbishing of Medical Device – Attached Table	2014
Regulations for Performance Report on Production, Export, Import and Refurbishing of Medical Device	2013
Regulations for Product Classifications of Medical Devices and Class by Product	2016
Regulations on Approving Clinical Investigation Plan for Medical Device	2013

Forms and Applications

Document	Year
Application for Designation of an Orphan Device – Attached Form	2013
Application for Designation of an Orphan Device	2013
Regulations for Prior Review of Medical Device Advertisement – Attached Form	2014

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