KOREA MARKET ENTRY KNOWLEDGE HUB
Entering Korea’s medical-device market. Find the information you need.
Explore the regulatory pathway and key considerations for your product and stage of preparation.
What do you need to know?
1Understand the flow
Korea Medical Device RegistrationKorean registration connects product classification, technical evidence, KGMP and the local applicant in one coordinated schedule.For Foreign ManufacturersAn overseas manufacturer should first define the Korean applicant and each party's evidence responsibilities.For Korean ImportersA Korean importer needs to prepare importer licensing, product authorization and post-import quality responsibilities together.2Prepare
Device Classification & Regulatory PathwaysMedical devices are divided into Classes I through IV by risk, and the Korean pathway varies by class and category.Documentation RequirementsPrepare product descriptions, safety and performance evidence, and manufacturing-site quality records as connected evidence sets.Testing & KGMP RequirementsCompare existing international test evidence with Korean requirements before commissioning additional work.The market-entry journey
Each stage shows the BCG service that supports it.
- 01STAGE 1
Classify
Confirm intended use, product category and class.
BCG supportDevice Classification & Regulatory StrategyExplore this stage - 02STAGE 2
Prepare evidence
Review technical documentation and test and quality evidence.
BCG supportProduct RegistrationExplore this stage - 03STAGE 3
Apply and respond
Progress product registration and any required KGMP assessment.
Explore this stage - 04STAGE 4
Launch and maintain
Import against the approved particulars and manage changes and renewals.
BCG supportPost-Approval MaintenanceExplore this stage
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.
Explore further insights
Check the official sources
This is general guidance. Check current official requirements for the individual product.
Need a product-specific assessment?
Attach your product description, intended use and any other material on the consultation page. BCG reviews it and replies by email with the procedure and next steps.
Start a consultation- 1Attach materialProduct description · intended use · overseas approvals
- 2BCG reviewCategory, class and required procedure
- 3Email replyOur review and suggested next steps