Question 1

What is Leanabl?

Accepted Answer

Leanabl is a medical device regulatory consulting firm based in Seoul, South Korea. We specialize in helping foreign manufacturers enter the Korean medical device market — covering MFDS registration, KGMP certification, KLH (Korea License Holder) services, post-market vigilance, and HIRA reimbursement listing.

Question 2

What is a KLH (Korea License Holder) and why does it matter?

Accepted Answer

In Korea, foreign medical device manufacturers cannot hold MFDS product licenses directly. A KLH (Korea License Holder, or importer of record) holds the license under their own name. Most manufacturers default to their distributor as KLH, which puts a business-critical regulatory asset under the distributor's control. Leanabl offers an independent KLH service that decouples your regulatory standing from your commercial relationships.

Question 3

How long does MFDS medical device registration take in Korea?

Accepted Answer

Timelines vary by device class. Class I (notification pathway) typically takes 30-60 days when properly prepared. Class II generally requires 60-90 days for MFDS review, plus KGMP inspection scheduling. Class III and Class IV devices can require 6-12 months or longer depending on clinical evidence requirements. Total end-to-end programs (registration + KGMP + KLH) typically run 4-9 months for foreign manufacturers.

Question 4

Does CE Mark or FDA 510(k) approval transfer to Korea?

Accepted Answer

No. CE Mark and FDA 510(k) approvals do not automatically transfer to Korea. MFDS requires Korea-specific technical documentation (Korean STED format), KGMP certification for the manufacturing site, and a Korean License Holder. While existing technical files significantly accelerate preparation, the submission itself must be re-formatted and translated to MFDS requirements.

Question 5

What is KGMP and how does it differ from ISO 13485?

Accepted Answer

KGMP (Korean Good Manufacturing Practice) is the quality system standard required for medical device manufacturers selling in Korea. While KGMP is harmonized with ISO 13485:2016, it includes Korea-specific requirements around manufacturing site inspection, change control documentation, and post-market obligations. ISO 13485 certification alone is not sufficient — foreign manufacturing sites must obtain separate KGMP certification through MFDS inspection.

Question 6

Does Leanabl work with AI/ML medical devices (SaMD)?

Accepted Answer

Yes. Leanabl provides regulatory pathway strategy for AI/ML-based Software as a Medical Device (SaMD) entering the Korean market. Korea has its own regulatory framework for AI medical devices that differs from FDA PCCP or EU MDR approaches. We help define the appropriate MFDS pathway, prepare Korea-specific clinical evidence, and coordinate with HIRA for reimbursement listing where applicable.

Question 7

How is Leanabl different from traditional regulatory consultants?

Accepted Answer

Leanabl is built on three principles: (1) No wasted motion — every deliverable answers a regulatory question, submissions get smaller and faster; (2) The work, not the show — senior practitioners handle the engagement directly, no pyramid billing or junior dossier shuffling; (3) Priced before you commit — fixed-fee where the path is known, named risks where it isn't, so you see the number before signing.

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