Local partner
Confirm the importer's role and responsibility for maintaining the authorization.
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For Foreign Manufacturers
An overseas manufacturer should first define the Korean applicant and each party's evidence responsibilities.
For Korean registration, the relationship between the local importer or authorization holder and the manufacturer should clearly cover responsibilities, access to evidence, change notification and control of the authorization.
Agree with your Korean partner
Evidence transfer
Define how technical, test and quality evidence will be shared and protected.
Change notification
Establish a process for notifying the Korean party of product and manufacturing-site changes.
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.