Question 1

Our device has CE MDR certification. How much of that technical file can be reused for Korea?

Accepted Answer

The substance of your CE technical file — test data, clinical evidence, risk management outputs — is the foundation we build from. However, the MFDS STED is a distinct document with Korea-specific section requirements, content standards, and labeling formats that do not map directly to EN ISO or MEDDEV structures. We restructure and adapt your existing documentation rather than translate it.

Question 2

What do we need to provide at project start?

Accepted Answer

We require your CE Technical File or FDA Submission Package, current labeling and IFU, product specifications, and intended use statement. All materials are exchanged under a signed NDA. We perform a documentation gap review at project initiation before scoping authoring requirements.

Question 3

How long does Class II, III, or IV MFDS registration take?

Accepted Answer

The MFDS review clock for a standard Class II submission runs 80 to 120 working days once the file is accepted. Total project timeline from engagement start to certificate issuance is typically 12 to 18 months, depending on testing requirements, MFDS review queue, and deficiency cycles.

Question 4

Can Leanabl also handle KGMP certification and HIRA reimbursement if we need them?

Accepted Answer

Yes. For manufacturers who also need KGMP certification or HIRA reimbursement listing, we recommend our Korea Full Market Authorization bundle, which coordinates all three tracks in a single managed program to avoid the sequencing errors that cause the largest timeline overruns.

Korea Device Registration

When Korea Device Registration Is the Right Fit.

First-Time Korea Entry for a Class II–IV Device

CE / FDA-Approved Device Entering Korea

Distribution-Independent License Control

Every Deliverable Required to Hold a Class II–IV License in Korea.

MFDS Product Classification Confirmation

Korean Predicate Device Analysis

Documentation & Testing Requirements Map

Submission Strategy Brief

MFDS Approvals Delivered for Class II, III, and IV Devices.

Class III Approval for a North American Cardiovascular Device Manufacturer

Class II Registration for a European Diagnostic Imaging Company

Frequently Asked Questions

Your MFDS-Issued Medical Device Product Approval Certificate.