The Ministry of Food and Drug Safety (MFDS) has revised the Regulations on Approval, Notification, and Review of Medical Devices to allow Real-World Evidence (RWE) as clinical evidence for modifying approved indications for use or instructions for use, provided changes remain within the originally authorized scope.
This marks a shift from the traditional reliance on formal clinical trial data and Clinical Study Reports (CSRs). By accepting evidence generated in routine clinical practice, the revised framework creates a more practical, data-driven pathway for post‑approval changes.
Why this matters beyond regulatory approval
Refining indications or instructions for use often affects reimbursement scope, eligible patient populations, and market-access strategy.
During reimbursement reviews by agencies such as the Health Insurance Review & Assessment Service (HIRA) and the National Evidence-based Healthcare Collaborating Agency (NECA), many products are classified as existing technology or as new/conditionally approved medical technology, but with restricted patient populations or limited coverage criteria.
Generating new clinical-trial evidence to support expanded or refined reimbursement positioning has previously required substantial time, cost, and operational burden.
A practical alternative: using real-world clinical data
The new MFDS notification offers a realistic alternative. Companies may now be able to use data collected from routine clinical practice
- to refine treatment methods or usage protocols and
- simultaneously reflect it in product approval change applications and reimbursement strategy.
For manufacturers, this reduces dependence on costly trials while accelerating regulatory and commercial objectives.
Timing and strategic considerations
The revised regulation took effect on April 28, 2026. Given recent trends toward pragmaticvadministrative interpretation, pending variation applications submitted before this date might also benefit from a more flexible review approach.
Companies considering indication refinement, reimbursement repositioning, or expansion of target patient groups should proactively assess whether RWE can support those objectives.
A broader industry shift
This development reflects a wider transformation in Korea’s medical-device landscape:
regulatory approval and reimbursement decisions are increasingly incorporating real-world clinical data.
How MDREX can help
MDREX supports medical-device companies through this transition with integrated services, including:
- RWE-based regulatory strategy development
- Planning and execution of medical-device change approval application
- Reimbursement-listing strategy
If you’d like an assessment of your product or technology’s insurance coverage prospects, optimal market-entry strategy, or potential regulatory/policy risks, contact MDREX at pro@mdrex.co.kr. MDREX is committed to helping your product move beyond approval to clinical adoption and market success.
