Adding a Medical Device Model in Korea: Build a Product Family Comparison

Start with what actually changes from the registered product, not the new catalogue. The regulatory procedure and the ability to reuse test evidence are separate questions and need separate conclusions.

1. Use registered specifications as the baseline

Devices described overseas as one series may have different intended uses or configurations in their Korean registrations. Freeze the current registration, amendment history, model list, controlled drawings and instructions as your baseline. Using only the catalogue of the marketed device can hide earlier changes that were never reflected in the registration.

Request the new specification, bill of materials, software version, accessory combinations and manufacturing site information. Record document numbers and revisions beside the comparison values. Mark missing information as unconfirmed; absence of evidence does not establish that two models are identical.

2. Show differences and their consequences together

This is an internal review example, not a mandatory list for every device. Adapt it to the product's characteristics and risks.

For a large family, separate common specifications from a difference register. Give each difference an affected document and an owner so that manufacturer questions and answers remain traceable.

3. Separate internal change categories from Korean procedures

A manufacturer calling a change minor within its quality system does not settle its regulatory treatment in Korea. Review the existing registration, actual changes and applicable rules to establish the relevant amendment route or other treatment. Whether models may be grouped and whether technical documentation review is needed also require distinct assessments.

A new model name does not, by itself, mean every test must be repeated. Identify unchanged and affected elements, then connect the regulatory route to the evidence required. See the change registration guide. Where the route is unclear, a focused enquiry supported by both specifications and a difference table is more useful than a question based only on a product name.

4. Select representative models for individual tests

The largest model may not represent electrical safety, biological safety and performance simultaneously. The model with the greatest output may differ from the model with the largest body contact area. A smaller enclosure may have a distinct battery or heat dissipation challenge. Establish the challenging condition from the test objective and actual design.

For each test, record the representative model, the rationale, covered variants and excluded differences. Reusing a report also requires a documented connection between its test article and current specifications. Check that drawings, component lists and verification support the manufacturer's explanation. Our foreign test report guide explains the evidence review.

5. Catch three common gaps before launch

A change described as colour only may involve a different pigment or patient contact material. The cosmetic description does not answer the biological risk question. Similarly, an optional wireless feature may include an app that provides alarms or displays results; assess its actual role rather than its commercial label.

A third gap occurs when the representative report identifies an old sensor but the new model ships with a replacement sensor. Even a correct comparison of the main units then fails to support the full configuration. A release checklist should link the model, accessory code, instruction revision, label and contents of the package.

6. Write three conclusions for each model

Record what differs, which evidence explains the effect on safety and performance, and which regulatory action and further evidence are needed. Assign an owner and expected delivery date to unresolved information; do not mark the review complete before its conditions are met. This process organizes the evidence for a decision rather than providing an automatic regulatory classification.

Bring the existing registration and new specifications to request a model addition review. Clare Partners can identify the change questions and evidence gaps to resolve first.

Official references: Korean Regulation on Medical Device Approval, Notification and Review · MFDS announcement of guidance on technical review for changes. Checked 2026-09-28. The historical guidance is a reference; applicable current rules take priority. Tables and workflow are practical recommendations.