Guidance on the Review and Approval of Digital Therapeutics(DTx)(Revision)
Information
Type
Regulation
Regulated products
Medical Devices
Published
November 4, 2020
Last updated
November 4, 2020
Description
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....
Tags
Organization
Country / Region
South Korea
License
Other (Public Domain)