Question 1

At what stage in the development process should we engage Korea Design Lock?

Accepted Answer

At or immediately after design freeze. The engagement requires a substantially complete V&V package, a finalized risk management file, and completed usability validation documentation. Engaging before design freeze means the gap analysis will be incomplete and will need to be repeated.

Question 2

Our device has CE MDR Technical Documentation. Can we reuse it directly for the MFDS STED?

Accepted Answer

Not directly. MFDS STED is a Korea-specific regulatory construct. Test reports must reference MFDS-accepted standards, which differ from EU harmonized standards in several categories — particularly for electrical safety, EMC, biocompatibility, and software documentation. We identify exactly which elements of your CE Technical Documentation are directly usable, which require restructuring, and which require new content.

Question 3

How long does the Korea Design Lock engagement take?

Accepted Answer

Typically 4 to 8 weeks, depending on the complexity of the device, the completeness of the existing documentation, and whether supplemental testing is required. Where supplemental testing is needed, the testing coordination timeline determines the overall engagement duration.

Question 4

If gaps are found in our V&V test reports, do we need to repeat all testing?

Accepted Answer

No. Most test standard gaps involve standards that have been updated or that MFDS has specified in domestic guidance. In many cases, test reports against equivalent or superseded standards can be supplemented with a gap test report covering only the delta. We identify the minimum additional testing scope required to close each gap — retesting from scratch is rarely necessary.

Korea Design Lock

When Korea Design Lock Is the Right Fit.

Post Design-Freeze, Pre-MFDS Submission

CE / FDA File Re-Used for Korea

SaMD or Digital Health Product Filing

Every Deliverable Required to File a Submission-Ready Technical Package.

STED Structure Audit

Test Standard Acceptance Map

Labeling & Korean-Language Documentation Review

Gap Classification & Remediation Plan

First-Cycle MFDS Approvals for Manufacturers Who Engaged Pre-Submission.

First-Cycle Class II Approval for a North American Diagnostic Device

SaMD Technical File Readiness for a European Digital Health Company

Frequently Asked Questions

A Submission-Ready Technical Package — With Every MFDS-Specific Gap Closed Before Filing.