Guidance on the Review and Approval of Artificial Intelligence (AI)-based Medical Devices
Information
Type
Regulation
Regulated products
Medical Devices
Published
July 20, 2023
Last updated
July 20, 2023
Description
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...
Tags
Organization
Country / Region
South Korea
License
Other (Public Domain)