Classify
Confirm intended use, product category and class.
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Korea Medical Device Registration
Korean registration connects product classification, technical evidence, KGMP and the local applicant in one coordinated schedule.
The usual path begins with product identification and classification, continues through evidence and testing, product notification, certification or approval and applicable KGMP work, and then moves into importing, distribution and post-approval maintenance.
Registration stages
Prepare evidence
Review technical documentation and test and quality evidence.
Apply and respond
Progress product registration and any required KGMP assessment.
Launch and maintain
Import against the approved particulars and manage changes and renewals.
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.