Entry feasibility
Check the regulatory path and evidence availability before contracting.
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For Korean Importers
A Korean importer needs to prepare importer licensing, product authorization and post-import quality responsibilities together.
Before adopting a product, the likely class, availability of manufacturer evidence, KGMP and possible Korean testing should be reviewed so that timing and cost can be assessed realistically.
Responsibilities before importing
Division of work
Separate manufacturer, test-laboratory and importer responsibilities.
Operational readiness
Prepare import inspection, records, labeling and post-market procedures.
Agree on partner responsibilities
| Area | Points to confirm |
|---|---|
| Manufacturer | Agree on access to product, test and quality documents and the contact for change notifications. |
| Korean partner | Confirm the applicant, local contact, submission records and follow-up scope. |
| Joint agreement | Document access rights, translation/testing costs, timing and document handover at contract end. |
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.