Guideline on the Review and Approval of In Vitro Diagnostic Devices for COVID-19

Guideline on Review and Approval of Artificial Intelligence(AI) and big data-based Medical Devices (For Industry)

Guideline on Review and Approval for Cybersecurity of Medical Devices (For industry)

Act on In Vitro Diagnostic Medical Devices

Brochure for Korean Medical Device(English Version) Contents - Korean Medical Device Market status - Korean Medical Device Regulation - Marketing Authorization/QMS/Recalls ~ - R&D for Medical Device - List of Reference materials for IVDs

Guidance on Patient-matched Medical Devices manufactured using 3D printers (published on December 10th, 2015)

Medical Device Standards and Specifications

Common Standards and Specifications on Biological Safety of Medical Devices (Addendum)

Common Standards and Specifications on Electromechanical Safety of Medical Devices

Common Standards and Specifications on Electromagnetic Safety of Medical Devices