Three Tracks. One Sequence. Get the Order Wrong and Lose 12 to 18 Months.
KGMP inspection must be cleared before MFDS grants a Class II or III product license. HIRA listing cannot begin without an active license. Managing each track with a different vendor compounds the risk: no single party is accountable for the sequencing logic.
One Program, One Team, One Accountability Structure — Across All Three Authorization Tracks.
We run registration, KGMP, and HIRA preparation as interdependent workstreams against a master program timeline.
Regulatory Pathway Strategy & Technical File Gap Analysis
Confirming MFDS classification, identifying HIRA technology category, and auditing the technical file against both MFDS STED and KGMP documentation requirements before committing to submission timelines.
Technical Documentation & Registration + Foreign Manufacturer KGMP Certification
Authoring the Korean STED and executing MFDS submission in parallel with QMS gap closure, mock audit, and MFDS inspection preparation — sequenced so that KGMP certification is in place before license issuance.
HIRA Reimbursement Listing
Preparing the National Health Insurance dossier and supporting HIRA evaluation once the product license is in hand — with clinical evidence and health technology assessment arguments built during the registration phase, not after.
The Sequencing Risk Is Not Theoretical — Misaligned Tracks Have Delayed Korea Launches by 12 to 18 Months.
Single Program Timeline
Leanabl holds a single program timeline across all three tracks, flagging interdependencies before they become crises — so registration, KGMP, and HIRA move in the order Korean regulation requires.
Pre-Built HIRA Evidence Strategy
Clinical evidence and health technology assessment arguments are built during the registration phase — not after license issuance — compressing the gap between MFDS approval and HIRA listing.
Coordinated Korea Market Entry for Full-Scale Manufacturers.
Complete Market Authorization Stack for a Japanese Medical Device Company
Delivered MFDS Class II product license, KGMP factory certification, and initiated HIRA evaluation for a Japanese orthopedic device manufacturer entering Korea — all managed under a single program timeline with no sequencing delays.
KGMP + HIRA Fast-Track for an Already-Registered European Device
For a European manufacturer with an active MFDS license, coordinated KGMP gap closure and simultaneous HIRA dossier preparation, reducing the time from KGMP inspection to HIRA application submission to under 8 months.
Korea Market Authorization — License, KGMP Certificate, HIRA Listing.
Leanabl manages the sequencing risk from day one — holding a single program timeline and ensuring that registration, KGMP, and HIRA move in the order that Korean regulation requires.
Speak with a Korea Market Entry Program DirectorFrequently Asked Questions
Common questions answered.