Guidance on Clinical Trials Design 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 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...
Tags
Organization
Country / Region
South Korea
License
Other (Public Domain)