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 |