A curated pipeline, not a logo wall.
Manufacturers entering Korea are pre-qualified through our Phase 1 consulting engagements. Partners receive opportunities with defined scope, validated budgets, and committed timelines — not unstructured leads.
The Korea MedTech Partner Network.
The operational backbone for foreign manufacturers entering Korea — extended globally, technically, clinically.
Why our partnerships actually move products.
Three structural choices separate the Leanabl network from a typical reseller program.
Compliance is the default, not an upsell.
Every project we route is structured against MFDS, KGMP, and ISO 13485 from day one. Partners inherit a clean regulatory framework instead of inheriting commercial ambiguity.
Integrated into a Lean operating model.
Partner deliverables are absorbed directly into a single technical file and submission package. This eliminates the 20–30% rework most Korea registrations lose to handoff friction.
A network mapped to the Korea regulatory lifecycle.
From pre-submission testing to post-market surveillance, every partner category exists to close a specific gap in a foreign manufacturer's Korea pathway.
Public Test Laboratories
MFDS-recognized labs (KTL, KTC, KCL, KTR) conducting safety, EMC, biocompatibility, and performance testing required for Korean registration.
Electrical safety (IEC 60601-1)Biocompatibility (ISO 10993)Performance & bench testing
Clinical Research Organizations
KGCP-compliant CROs and academic medical centers supporting Korean clinical investigations, real-world evidence, and NECA new-health-technology evaluation.
MFDS clinical trial INDNECA evidence generationPost-market clinical follow-up
Global Regulatory Partners
Cross-jurisdictional RA firms in the US, EU, Japan, and ASEAN. We route our clients' outbound scope to trusted partners; they route their Korea scope to us.
FDA 510(k) / De Novo / PMAEU MDR / IVDRPMDA & ASEAN registration
Distributors & Channel Partners
Korean distributors who want to focus on commercial sales while leaving the product license, vigilance, and post-market obligations with an independent KLH.
Independent KLH separationCommercial-only distributor agreementsChannel co-marketing
Specialized Technical Vendors
Cybersecurity assessors, usability engineering firms, AI/ML validation specialists, and sub-experts that plug into our SaMD and Class III pathways.
MFDS cybersecurity dossierUsability (IEC 62366-1)AI/ML SaMD validation
Industry Associations
MedTech trade bodies whose foreign-manufacturer members need a credible Korea entry partner — and a transparent, independent License Holder.
Member-exclusive Korea workshopsCo-authored regulatory briefingsTrade-mission support
Three programs. One operating model.
Each program defines its commercial model, scope of engagement, and the support you receive from our partnerships team.
Tier 01
Referral Partner
Best for:
Consultancies, law firms, and industry associations whose clients need Korea access.
- Revenue share on referred engagements
- Co-branded Korea regulatory briefings
- Named introduction to MFDS pathway experts
Tier 02
Solution Partner
Best for:
Test labs, CROs, and technical vendors who deliver scope inside a Korea registration project.
- Integrated into Leanabl turn-key pathways
- Pre-scoped statements of work and milestone billing
- Shared technical file structure to eliminate rework
Tier 03
Strategic Partner
Best for:
Global RA firms and platform vendors building a long-term Korea–Asia footprint with Leanabl.
- Reciprocal client routing across jurisdictions
- Joint go-to-market for SaMD and AI/ML programs
- Dedicated success lead and quarterly business reviews
From inquiry to active pipeline in four steps.
A lightweight process designed to validate fit quickly and deliver value within the first quarter.
Apply
Submit a short partnership inquiry. We screen for regulatory alignment, geographic fit, and complementarity with our solution portfolio.
Fit Assessment
A 45-minute call with our partnerships lead maps your capabilities against active Korea, KGMP, KLH, and SaMD engagements.
Onboarding
We codify scope, deliverables, and quality expectations into a partner playbook so your team integrates cleanly with our project delivery model.
Active Pipeline
You receive qualified opportunities. We maintain a single source of truth across projects and run quarterly partner reviews.