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Sandbox Regulatory Program

Korea operates a regulatory sandbox program that allows novel technologies — including digital health and medical device innovations — 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) — apps that deliver therapeutic interventions
  • AI-assisted diagnostic tools — where classification as SaMD is uncertain
  • Remote monitoring platforms — 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: — Represent genuinely novel technology not clearly addressed in existing regulations — Have potential for significant public health or clinical benefit — Not pose unacceptable safety risks during the testing period

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

Post-sandbox pathway ​ Upon sandbox completion, the product must either: — Transition to standard 품목허가 pathway with regulatory guidance informed by sandbox data — Seek conditional marketing authorization if appropriate — Exit the Korean market if the permanent regulatory pathway is not pursued

Devices operating under sandbox permits may be supplied commercially during the testing period, but pricing and volume restrictions are typically imposed by MFDS. The sandbox operator (manufacturer) bears liability for device safety and must maintain product liability insurance. MFDS may impose restrictions on distribution geography and patient population during sandbox operation. Post-sandbox transition to standard 품목허가 requires submission of all sandbox-collected safety and performance data.