Define your exact route to the Korean market. Zero guesswork.
MFDS pathway, NECA, HIRA, KGMP and KLH — sequenced and priced before you commit budget. One senior team, end-to-end.
Korea at a glance.
The shape of the work — typical class, timelines, and what changes vs. EU/US.
Authority
MFDS
Ministry of Food and Drug Safety. Separate sequencing with NECA (HTA) and HIRA (reimbursement).
Classification
I · II · III · IV
Korean class can differ from EU/US. A Class II elsewhere may be Class III here.
QMS
KGMP
On-site or paper-based audit depending on class and manufacturing location.
Local rep
KLH required
Korea License Holder holds the product license. Independent KLH protects your IP.
Timeline
6–18 months
From kickoff to MFDS registration, depending on class and clinical evidence.
How a Korea entry runs with us.
Four phases. Each ends in a written deliverable your leadership can act on.
Pathway assessment
Confirmed MFDS class, predicate analysis, NECA/HIRA sequencing, and an itemized budget. 2–4 weeks.
Technical file & QMS
STED-style dossier, KGMP gap closure, and any clinical/performance evidence required by class.
Submission & audit
MFDS submission, queries, and the on-site or paper KGMP audit. We sit on the file with you.
License & post-market
Independent KLH, change notifications, vigilance, renewals, and HIRA reimbursement work.
Everything you need to enter Korea, step by step.
Project work mapped to the right mix of services and solutions across the regulatory lifecycle.
Strategy & Pathway
Define the cleanest route to market before you commit budget.
Submission & Approval
Build the dossier, run the audit, ship the registration.
Solutions
Operate & Maintain
Stay licensed and audit-ready after you launch.
Solutions
Korean regulatory acronyms, at a glance.
The agencies and instruments that shape every Korea program.
- MFDSMinistry of Food and Drug Safety
- Central regulator for medical devices. Handles classification, registration, and post-market oversight.
- KGMPKorea Good Manufacturing Practice
- Quality system standard aligned with ISO 13485, with Korea-specific procedural deltas.
- KLHKorea License Holder
- Local legal entity that holds the MFDS license. Independent KLH separates regulation from distribution.
- NECANational Evidence-based Healthcare Collaborating Agency
- Runs new health technology assessment (nHTA) for novel devices before reimbursement.
- HIRAHealth Insurance Review & Assessment Service
- Sets reimbursement codes and pricing for devices entering the national health insurance system.
- KOTRA-MDMFDS device classification list
- Korean product code system used to align imported devices with local categories.
Frequently asked questions about Korea entry.
Quick answers on timing, scope, and how we work with your existing distributor or KLH.
Ready to map your route into Korea?
Tell us about your product. We respond within five business days with a scoped Pathway Assessment proposal.
Speak with a strategy director