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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 β€” the software must deliver a clinical intervention, not just information
  • Evidence requirements β€” clinical trial evidence of efficacy required for ν’ˆλͺ©ν—ˆκ°€
  • Grade assignment β€” 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 follow the standard SaMD β†’ ν’ˆλͺ©ν—ˆκ°€ pathway, with:

  • 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.