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Medical Device Importer Licensing
A Korean medical-device importer must establish the business role and statutory requirements before importing.
When a review helps
Separate business licensing from product authorization
Review personnel, facilities and application material
When is this service useful?
Importer licensing and product notification, certification or approval are separate procedures, but they are operationally connected. We review the quality manager, facility and quality controls together with the first product plan.
Key areas of review
Eligibility
Confirm the organization and quality-manager requirements for importer licensing.
Application preparation
Organize the application and supporting business and facility records.
Product connection
Plan the first product application and post-import obligations together.
Prepare for your review
- Business and place-of-business information
- Quality-manager qualification records
- Organization and responsibility matrix
- Products planned for import
How We Work
Review the business structure
Confirm the legal entity, place of business and responsible organization.
Check requirements
Review quality-manager, facility and document requirements.
Support the application
Prepare required records and the administrative filing.
Prepare operations
Connect import inspection, recordkeeping and reporting procedures.
Separate business readiness from product readiness
Distinguish importer setup from product-specific preparation and assign clear document and confirmation lists.
The specific scope and deliverables are agreed after product and evidence review.
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.