Korea Full Market Authorization
Three Tracks. One Sequence. Get the Order Wrong and Lose 12 to 18 Months.
When Korea Full Market Authorization Is the Right Fit.
Three scenarios where foreign manufacturers can't afford to split registration, KGMP, and HIRA across vendors with no single owner of the sequence.
End-to-End Korea Market Entry
Class II–IV manufacturer entering Korea from scratch — MFDS registration, KGMP, and HIRA under one program, one timeline owner.
Reimbursement-Critical Product Strategy
Korea commercial model depending on HIRA — evidence built during registration, not retrofitted after license issuance.
Already-Registered Device Adding KGMP + HIRA
MFDS license active — KGMP and HIRA as a coordinated follow-on, not two vendors with conflicting timelines.
Every Deliverable Required to Complete the Korea Market Authorization Stack.
Three coordinated services running against a single program timeline.
- / 01
MFDS Classification & HIRA Category Mapping
Written confirmation of MFDS class and HIRA technology category — the two anchors that drive every downstream document.
- / 02
Dual Gap Analysis (STED + KGMP)
Existing technical file audited against both MFDS STED and KGMP requirements — different gaps, different remediation timelines.
- / 03
Master Program Timeline
Integrated timeline of the legally required sequence: KGMP before license, license before HIRA, with parallel work where regulation allows.
- / 04
HIRA Evidence Strategy Brief
Clinical evidence and HTA arguments defined for build during registration — not after license issuance.
Coordinated Korea Market Entry for Full-Scale Manufacturers.
Complete Market Authorization Stack for a Japanese Medical Device Company
KGMP + HIRA Fast-Track for an Already-Registered European Device
Frequently Asked Questions
Common questions answered.
Korea Market Authorization — License, KGMP Certificate, HIRA Listing.
Sequencing risk managed from day one — registration, KGMP, and HIRA moving in the order MFDS requires.
Speak with a Korea Market Entry Program Director