A Growing Korea Portfolio Creates Compliance Obligations Faster Than Any Single Team Can Track Them.
An active Korea portfolio does not scale compliance linearly. Each product license carries its own renewal deadline, change notification history, and vigilance record — and MFDS routine audits examine all of these records simultaneously.
One Team, One Program, All Compliance Obligations — Across Your Entire Korea Portfolio.
We assume operational responsibility for every post-registration compliance function, running as a single integrated program against a unified compliance calendar.
Korea License Holder (KLH) + License Renewal Management
Leanabl holds your licenses independently of your distributors and manages all renewal applications across your portfolio on a unified deadline calendar, with no single renewal at risk of being missed.
Vigilance / Adverse Event Reporting + Change Notification Management
Structured processing of all adverse event reports within Korean Medical Devices Act timelines and management of all device change notifications — reviewed, classified, and filed within MFDS-required windows.
Regulatory Intelligence / Monitoring
Continuous monitoring of MFDS regulatory updates, guidance publications, and policy changes affecting your product categories, with actionable summaries delivered to your RA team on a regular cadence.
MFDS Audits Examine Your Entire Compliance Record — Partial Preparation Exposes Everything You Did Not Manage.
Unified Compliance Record Across All Products
One program, one record, one team accountable for every compliance obligation across your entire portfolio — so that an MFDS audit finds a coherent, complete compliance record, not a fragmented one.
Monthly Regulatory Intelligence Briefings
We deliver monthly briefings covering MFDS updates, guidance changes, and policy developments relevant to your product categories — so your RA team has the intelligence needed before regulatory changes affect your products.
Audit-Ready Korea Compliance for Growing and Complex Portfolios.
Post-Market Compliance Consolidation for a 12-Product Korea Portfolio
Assumed full KLH, vigilance, change notification, and renewal management for a North American manufacturer with 12 registered Korea products — consolidating three fragmented service arrangements into a single program and eliminating a backlog of unfiled change notifications within 90 days.
MFDS Audit Preparation for an Active Growing Portfolio
For a European manufacturer who received an MFDS routine inspection notice, completed a full compliance record review and remediation across eight products under the Post-Market Operations program — entering the audit with a documented, gap-free compliance record.
A Complete, Audit-Ready Korea Post-Market Compliance Record.
Korea Post-Market Operations eliminates the fragmentation that creates audit exposure: one program, one record, one team accountable for every compliance obligation across your entire portfolio.
Speak with a Korea Post-Market Operations Manager TodayFrequently Asked Questions
Common questions answered.