Reviewing Overseas Clinical Evidence for Korea: Does It Support the Proposed Intended Use?

Ask how well the evidence explains the actual imported model and its proposed Korean use. Record what it does not explain rather than ending the review at an overseas approval.

1. Fix the Korean application question

Before gathering volume, define condition, population, body site, operator, setting and claimed effect. Evidence for a narrow overseas population may not support a wider Korean sales plan. Expanding claims first and searching for support later reverses the review process.

Separate which clinical evidence is required from whether existing evidence is applicable. Establish requirements for the item and application type, then assign a role to each available source. The clinical investigation guide helps distinguish trial authorization from review of supporting evidence.

2. Distinguish publications, study reports and approvals

A paper presents published findings, a study report provides fuller conduct and analysis, and an overseas approval records a regulatory decision. They serve different purposes even when related to one study. Record titles, versions, study identifiers, device models and the manufacturer's access to documents.

An abstract or promotional summary may omit exclusions, protocol changes, adverse events or limitations. Obtain the full publication and establish what plans and reports exist for manufacturer-sponsored research. Define necessary source material from the review question and submission requirements rather than demanding one universal bundle.

3. Explain differences in an applicability matrix

IMDRF's clinical evaluation guidance considers evidence quality and relevance to the device and intended use. N56 excludes in vitro diagnostic devices from its scope; assess their clinical performance evidence under the applicable separate requirements. The following is an internal implementation aid, not a Korean statutory form.

For each difference, record its possible effect and supporting explanation, not only yes or no. Examine clinically relevant characteristics and care practices rather than treating nationality as the conclusion.

4. Support bridges from comparable devices

Separate evidence for the application device from predecessor or other manufacturers' devices. Similar names or operating principles can conceal differences in design, materials, energy delivery and use. Explain differences and the evidence for why they do not invalidate the proposed clinical inference.

Review design comparisons, nonclinical performance and biological evidence where relevant. Disclose inaccessible information. Declaring equivalence before the comparison can be made weakens later conclusions. The foreign test report guide supports the nonclinical part of the review.

5. Summarize favourable findings and limitations together

Record exclusions, loss to follow-up and design limitations with the main results. Check whether several papers analyze the same cohort to avoid counting the same evidence repeatedly. More papers do not compensate for excluding unfavourable findings.

Where a manufacturer's no-issue summary differs from the report, base questions on the report. The implications of small populations or short follow-up depend on device risk and the claim. Consider clarification, revised claims or further evaluation before assuming a new Korean study is automatically necessary.

6. State supported scope and remaining questions

For each source, identify supported claims, conditions, limitations and next actions. Evidence existence does not mean full coverage of the intended use. Revisit conclusions whenever the application or technical documentation changes its intended-use wording.

Bring the Korean intended use, study inventory and available reports to request an overseas clinical evidence review. Clare Partners can distinguish required evidence from the role existing materials can support.

Official references: IMDRF Clinical Evaluation, N56 · Korean medical device review regulation. Checked 2026-09-28. IMDRF guidance is an international reference, not a replacement for Korean submission requirements. Tables and workflow are practical recommendations.