What Was Announced — Scope of the September 10 Revision
On September 10, 2026, the National Institute of Food and Drug Safety Evaluation (NIFDS), an agency under Korea's Ministry of Food and Drug Safety (MFDS), revised its Guideline on Preparing Clinical Trial Protocols for Digital Therapeutics. The revision covers seven indications:
Three changes stand out.
The guideline is an advisory document for applicants and is not legally binding. Because it reflects protocol reviews accumulated since the Act took effect, it is best read as a guide to what reviewers look for. Unlike guidance on software used by clinicians, this revision concerns clinical design for patient-facing digital therapeutics (DTx).
Why It Matters — Where DTx Protocols Tend to Be Weak
The points that draw requests for supplementation in DTx protocols are largely the same.
Guidance on setting the MCID means the second question now has to be answered at the protocol stage.
Building Indication-Specific Endpoints and MCID into the Protocol
Endpoints and assessment timing
Narrow the primary endpoint to one. If it differs from the examples the guideline gives for your indication, justify the choice with literature. Secondary endpoints should include functional and quality-of-life measures, plus follow-up assessments that show whether the effect lasts after treatment ends.
MCID, sample size and cost
The MCID is the starting point for sample size. A simple illustration, assuming a two-arm comparison with two-sided 5% significance and 80% power, shows the stakes.
The enrollment target grows about 2.8 times depending on the assumed effect size. An optimistic assumption leaves the trial underpowered, and a conservative one inflates the budget. That is why the exploratory trial should estimate effect size and dropout, and the confirmatory trial should test against the MCID.
Pre-defining usage data
Usage data such as days of access and module completion rates should be defined in the protocol as adherence measures. Criteria set after the fact weaken the credibility of the analysis.
Expected by Year-End — Three Documents on Digital-Drug Combination Products
MFDS is working to prepare the following three documents by December. None is final yet, so timing and content may change.
A digital-drug combination product is a drug combined with a digital medical device or a digital medical and health support device, and it requires its own product approval. This can open opportunities for small DTx companies working with pharmaceutical partners. Roles such as who leads clinical design, who owns the data and who is responsible for software change control should be settled at the contract stage.
A Practical Checklist for SME DTx Developers
How KITIM Can Help
KITIM connects companies with specialists in digital medical device regulatory strategy and clinical planning, and supports biohealth R&D project planning and proposal writing. If you need a review of your clinical design against the revised guideline or a plan for funding your trial, please request a KITIM consultation. We will work with you to find an approach that fits your stage of development.