Home / Korea Market Entry
Timelines & Costs
Class alone cannot determine timing or cost; evidence gaps, testing and KGMP are material variables.
A reliable estimate follows product classification and evidence review. Planning should cover not only authority review time but also translation, manufacturer responses, laboratory scheduling and possible supplementary questions.
What changes a schedule or estimate
| Review variable | Schedule and estimate considerations |
|---|---|
| Product variables | Class, category and technical-document review scope. |
| Evidence variables | Suitability of existing tests and the translation or remediation scope. |
| Operational variables | KGMP, manufacturer response time and local-applicant readiness. |
Separate the cost components
| Area | Points to confirm |
|---|---|
| Consulting and documentation | Clarify evidence review, translation, manufacturer questions and submission support. |
| Tests, assessments and fees | Check whether third-party testing, assessment and official fees are included. |
| Changes and extra work | Agree how scope changes and additional review work affect the estimate. |
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
Clarify 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.