Scaling 14-Product Portfolio Through MFDS in 9 Months

The Setup

A European cardiovascular manufacturer with 14 SKUs — 4 Class II implants and 10 Class I accessories — needed market authorization in Korea. They had an existing distributor relationship that was working in other markets but was new to Korean regulatory operations. The original plan was to submit the flagship Class II implant first, learn the system, then submit the accessories over the following 18 months.

That plan would have delivered full portfolio market authorization in roughly 24 months, with the early SKUs going to market while the later SKUs sat in regulatory queue.

The Strategic Shift

Sequential submission optimizes for risk — start with one product, learn, expand. Portfolio submission optimizes for time-to-market across the full SKU range and for operational consolidation (one KGMP audit, one KLH structure, one technical file architecture).

For this manufacturer, the math favored portfolio. Three reasons:

1. Cardiovascular SKUs sell in sets. The implants are used with the accessories in the same procedure. Having only implants approved without accessories would not have produced material revenue — physicians need the full kit.

2. A single KGMP audit covers a manufacturing site, not a SKU. Submitting one product gets the same audit as submitting 14, if all 14 are made at the same site.

3. Technical file reuse. Many components, materials, sterilization processes, and quality data were shared across SKUs. Building a coordinated technical file architecture once is cheaper than rebuilding it 14 times.

What We Did

The work split into three workstreams running in parallel.

Workstream 1: Classification and Item Coding

The first eight weeks were spent on Korean classification opinions for all 14 SKUs and locking the MFDS item codes. Two surprises emerged:

• One accessory that classified as Class I in EU classified as Class II in Korea because of an intended-use phrasing difference. We rephrased the intended use to support Class I positioning, which required a labeling change but saved 8 months of additional Class II review on that SKU.
• Two SKUs that the manufacturer had treated as separate products fell under the same Korean item code. We consolidated them into a single submission, reducing administrative overhead.

Workstream 2: Shared Technical File Architecture

Rather than 14 standalone technical files, we built a master technical file with:

• Common modules (sterilization validation, biocompatibility for shared materials, supplier qualifications, manufacturing process validation) referenced from every SKU submission.
• SKU-specific modules (intended use, dimensional specifications, packaging, labeling) per submission.

This structure passed MFDS pre-review without issue. The reviewer treated the shared modules as a unified source of truth and the SKU-specific modules as the differentiating content.

Workstream 3: Unified KGMP and KLH

We coordinated a single KGMP audit covering the full manufacturing scope rather than three audits for incremental scope. The audit was a 4-day on-site visit covering all relevant production lines. Audit findings (5 total, all minor) were closed within 30 days.

For KLH, we set up an independent KLH structure under the KLH Service — the manufacturer wanted to retain distributor flexibility and was already evaluating a potential second distributor for the southern region of Korea. The independent KLH structure meant we could add the second distributor 6 months later without re-registration.

The Timeline

Month	Milestone
Month 1	Kickoff, classification opinions, item code lock
Months 2–3	Technical file architecture, KGMP audit scheduling, KLH agreement
Months 3–5	Korean translation and submission preparation
Month 5	KGMP on-site audit (single audit, 4 days)
Months 5–8	MFDS substantive review, two RAIs (both clarification-level)
Month 8	KGMP certificate issued
Month 9	All 14 MFDS notifications cleared, labeling printed, first shipment lands

Where the Savings Came From

A rough comparison of approaches:

Element	Sequential approach	Portfolio approach
Time to full portfolio approval	~24 months	9 months
KGMP audits	2–3 separate audits	1 audit
KLH transitions	Multiple (sequenced)	Single setup
Technical file work	14 standalone files	1 master + 14 SKU modules
Distributor revenue timing	Trickle (over 24 months)	Step (at month 9)
Estimated regulatory spend	Baseline	~60% of baseline

The 40% spend reduction was less about per-task efficiency and more about avoiding the duplication that comes from sequential filings: re-explaining the same shared technical content, re-coordinating the same KLH paperwork, re-engaging the same KGMP auditors.

What Made This Work

This was not a generic playbook. Three preconditions made the portfolio approach viable:

1. All 14 SKUs were made at the same manufacturing site. Multi-site portfolios still require per-site KGMP audits.
2. The manufacturer had a clear product roadmap and was not adding SKUs mid-stream. Mid-project SKU additions break the portfolio architecture.
3. The distributor relationship was stable enough that the independent KLH decision was not under pressure from the commercial team. Distributor-tied KLH structures cannot be reconfigured mid-portfolio submission without significant disruption.

For manufacturers without these preconditions, sequential submission is still the right answer. For those with them, portfolio submission cuts time and cost meaningfully.

What This Did Not Solve

This case study covers MFDS market authorization and KGMP. It does not cover:

• Reimbursement (HIRA/NECA), which followed the approval work as a separate 12-month program.
• Commercial launch readiness, which the distributor handled independently.
• Class III SKUs, which were not in the portfolio at the time of this engagement.

The reimbursement work began in Month 6 — running in parallel with the MFDS review so that reimbursement readiness was advanced when approval landed.

Where Leanabl Plugs In

This engagement was delivered through the Korea Portfolio MA solution, which structures multi-SKU market authorization as a single coordinated workstream. For manufacturers wanting the full path from regulatory through reimbursement, Korea Full Market Authorization bundles the end-to-end program. The KLH structure was set up through the KLH Service and is now maintained through Korea License Maintenance.