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Digital Therapeutics (DTx) Regulation

Digital Therapeutics (DTx, 디지털 치료기기) are evidence-based software interventions used to prevent, manage, or treat a medical condition. Korea is one of the first countries globally to establish a dedicated regulatory pathway for DTx.

MFDS approach to DTx​

MFDS classifies DTx as SaMD when they meet the intended use criteria for a medical device. Key considerations:

  • Active therapeutic intent — the software must deliver a clinical intervention, not just information
  • Evidence requirements — clinical trial evidence of efficacy required for 품목허가
  • Grade assignment — typically Grade II or III depending on the condition being treated

Notable Korean DTx approvals​

Korea has approved several DTx products, including:

  • DTx for cognitive training in dementia prevention
  • DTx for smoking cessation
  • DTx for attention deficit disorder (ADHD)

Regulatory pathway​

DTx products follow the standard SaMD regulatory pathway to obtain 품목허가 (product authorization), with the following requirements:

  • Clinical trial data demonstrating therapeutic efficacy
  • User experience design documentation (as SaMD usability)
  • Post-market performance monitoring plan

Regulatory sandbox for DTx​

Novel DTx products may be eligible for the regulatory sandbox program while their classification is being determined.

Clinical trial requirements for DTx: MFDS expects randomized controlled trials (RCTs) comparing the DTx to standard of care or placebo, depending on the therapeutic area. Study duration must demonstrate sustained efficacy, and primary endpoints must align with clinical outcomes relevant to the indication. Patient-reported outcome measures (PROMs) are typically required in addition to objective clinical endpoints.