This guidance applies to the regulatory pathways of clinical trial approval, manufacturing, and import licensing (subject to clinical trial data submission) or technical documentation review (subject to clinical trial data submission) for machine learning-enabled medical devices that analyze medical...

This guidance applies to machine Learning-enabled medical devices, in which machine learning-based AI technology is applied to diagnose, manage, or predict diseases by analyzing medical data. They also apply to AI software configured using hardware. For example, clinical decision supporting (CDS) an...

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

This guidance shall apply to the approval/certification of the manufacturing/import, review of technical documents, and approval of clinical trial protocols for a DTx that provide evidence-based therapeutic intervention to patients for preventing, managing, or treating medical disorders or diseases....

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)