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Sandbox Regulatory Program

Korea operates a regulatory sandbox program that allows novel technologies β€” including digital health and medical device innovations β€” to be tested in a real-world environment before a clear regulatory pathway exists.

What the sandbox allows​

  • Products that do not clearly fit existing regulatory categories may be granted a temporary permit to be used commercially for a defined period
  • During the sandbox period, MFDS gathers real-world evidence to inform the permanent regulatory pathway
  • The sandbox operator must meet basic safety requirements and data collection obligations

Relevance for digital health​

The sandbox has been particularly relevant for:

  • Digital Therapeutics (DTx) β€” apps that deliver therapeutic interventions
  • AI-assisted diagnostic tools β€” where classification as SaMD is uncertain
  • Remote monitoring platforms β€” connected device platforms with novel data flows

How to apply​

Apply to MFDS or the Ministry of Science and ICT (depending on the product type) via the relevant regulatory sandbox portal.

Eligibility and application requirements ​ Products eligible for sandbox testing must: β€” Represent genuinely novel technology not clearly addressed in existing regulations β€” Have potential for significant public health or clinical benefit β€” Not pose unacceptable safety risks during the testing period

Application materials must include: β€” Detailed product description and technology overview β€” Proposed real-world testing environment and duration (typically 1–3 years) β€” Safety and performance monitoring plan β€” Data collection and reporting obligations

Post-sandbox pathway ​ Upon sandbox completion, the product must either: β€” Transition to standard ν’ˆλͺ©ν—ˆκ°€ pathway with regulatory guidance informed by sandbox data β€” Seek conditional marketing authorization if appropriate β€” Exit the Korean market if the permanent regulatory pathway is not pursued