How long does the Pathway Assessment take?

Typically 2–4 weeks after we receive the product description, IFU, and current CE/FDA status.

Do we need to share our full Technical File?

No. We can start with product description, IFU, and current clearances after NDA.

Distributor-held licenses create leverage over your business. Independent KLH and RA protect control.

Yes. If you retain us for registration, the Pathway fee can be credited against project scope.

Yes. We can work alongside an existing KLH and shift to independent KLH later if needed.

MFDS, KGMP, importer/KLH, reimbursement, and post-market work. Sequenced before you commit budget.

The regulatory shape of a Korea entry program.

Authority

MFDS regulates devices. NIDS supports classification and selected registration routes.

Classification

I · II · III · IV

Korean class can differ from EU/US and determines the registration route.

QMS

KGMP

Audit route depends on class, device type, and manufacturing location.

Importer / KLH

Importer required

A Korean importer/KLH holds and maintains the license.

Timeline

6–18 months

Typical range from kickoff to registration, depending on class and evidence.

Four phases, each ending in a written decision or deliverable.

Korea class, pathway, predicate logic, sequencing, and budget. 2–4 weeks.

Korea technical documentation, KGMP file, and evidence required by class.

Submission to the right review body, NIDS, or MFDS, with KGMP review managed in parallel.

Importer/KLH operations, changes, vigilance, renewals, and reimbursement work.

Choose the work by lifecycle stage.

Define the cleanest route to market before you commit budget.

Products

Services

Timing, scope, and distributor/KLH questions.