Test gap
Check standard versions, test samples and model representativeness.
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Testing & KGMP Requirements
Compare existing international test evidence with Korean requirements before commissioning additional work.
Electrical and mechanical safety, EMC, biological safety and performance testing depend on product characteristics. KGMP should be reviewed together with the relevant manufacturing site and product-group scope.
Testing and quality assessment
Additional testing
Identify missing items and prioritize any Korean submission work.
KGMP
Confirm the site, product group, assessment approach and evidence readiness.
Separate testing evidence from KGMP preparation
| Area | Points to confirm |
|---|---|
| Testing evidence | Check the model, intended use, methods and results against product claims and submission documents. |
| KGMP readiness | Separately review product/site scope, quality documents and assessment readiness. |
| Before more testing | Review the coverage and gaps of existing reports before agreeing on additional testing, methods and timing. |
Frequently Asked Questions
What should we prepare for an initial discussion?
Product information, intended use, manufacturing details, approvals and available testing evidence.
When can timing be estimated?
After likely classification and material evidence gaps have been reviewed.
MFDS medical-device regulations · MFDS medical-device approval process · Content baseline · Check current requirements for the specific product
CONSULTATION
Start a consultationClarify the Korean regulatory pathway for your product.
Attach what you have and we will reply by email after reviewing it. You do not need a complete set of documents.