South Korea Medical Device Regulations

Log into RAMS to download the documents listed below along with more regulations and guidances for South Korea.

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Major Regulations
Document Number Published Language
Log in Enforcement Regulations of the MDA English
Log in Regulations on IVD Medical Device Approval, Notification, Examination, etc. Korean
Log in Enforcement Regulations of the IVD Act Korean
Log in In Vitro Diagnostic (IVD) Medical Devices Act (IVD Act) Korean
Log in Regulation for Medical Device Approval, Notification, Review MFDS Notification No. 2019-13 02/2019 Korean
Log in Medical Devices Act Act No.13116 2015 Korean
General Guidance Documents
Document Number Published Language
Log in Regulations on In Vitro Medical Device Codes and Classification Korean
Log in Regulations on Medical Device Codes and Classification Korean
Log in IVD Medical Device Manufacturing and Quality Control Standards Korean
Log in Medical Device Manufacturing and Quality Control Standards Korean