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

RegulationYear
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

DocumentYear
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

DocumentYear
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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