D-rapy

In particular, the DTx products for treatment on behavior correction, chronic diseases, and collection and analysis of patient's data have been developed recently in clinical field. Therefore, in order to provide proactive and predictable regulations for the novel field, it is necessary to set forth definitions, criteria and the methods for review and approval of a DTx.

This guidance is based on the “Regulation on Medical Device Approval/Report/Review, Etc” of the Enforcement Regulation of the Medical Device Act (hereinafter referred to as "Regulation") and seeking to enhance transparency in applicant’s convenience and duties of 1 review and approval by representing the current scope, criteria, and the methods for review and approval of a DTx.

<Scope> 

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.