Change Notification Management
Every Change to Your Device Needs a Regulatory Decision. Make It Before MFDS Makes It for You.
Unnotified changes to your approved device create silent compliance violations in Korea.
Unreported product, software, labeling, or site changes can trigger Korean import suspension — regardless of whether the change affected safety or performance.
Regulatory Impact Assessment
We evaluate every product change against MFDS criteria for what constitutes a major change (requiring prior approval) versus a minor change (requiring prompt notification), ensuring no change goes unclassified.
Change Classification and Routing
Based on our assessment, we determine the correct MFDS filing pathway — change approval application, administrative notification, or documentation-only update — and prepare the required submission package.
MFDS Filing and Confirmation
We manage the complete MFDS submission process for each change, obtain official receipt and approval confirmations, and maintain a structured change log that serves as your Korean regulatory history of record.
What You Receive
Leanabl maintains a complete, audit-ready change management record for your Korean registrations — ensuring every product update is documented, filed, and confirmed with MFDS.
Frequently Asked Questions
Common questions about Korean medical device change notification requirements and how Leanabl's service works.
Shipping an Unapproved Change into Korea Is a Compliance Violation — Even if the Change Was Safe.
Every change assessed and filed before the first unit ships. Import suspension risk eliminated, license protected.
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