Average consultant experience
We make Korea market entry
move forward.
From classification and registration to KGMP and post-approval maintenance, BCG turns Korean regulatory complexity into a clear plan of action.
OUR SERVICES
View all services Specialist services for every product stage
Scope and timing are confirmed after an initial product and document review.
STEP 01
Device Classification & Regulatory Strategy
Review the category and class, then plan the order of registration work.
Learn moreSTEP 02Korea License Holder (KLH)
BCG holds your Korean approval, so you can enter without a local entity.
Learn moreSTEP 03Medical Device Importer Licensing
Support for the requirements and documentation needed to obtain an importer license.
Learn moreSTEP 04Product Registration
Support for notification, certification, approval and authority questions by device class.
Learn moreSTEP 05KGMP Audit Support
Preparation and audit support for manufacturers and Korean importers.
Learn moreSTEP 06Post-Approval Maintenance
Support for regulatory changes, renewals and ongoing approval maintenance.
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