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.
Foreign manufacturers frequently introduce product updates — software version changes, component substitutions, labeling revisions, manufacturing site modifications — without realizing these may constitute 'major changes' requiring MFDS pre-approval or 'minor changes' requiring prompt notification. Shipping an updated product into Korea without the correct MFDS filing is a compliance violation that can trigger import suspension, regardless of whether the change affected safety or performance.
Always-On Change Assessment and Immediate MFDS Filing.
Leanabl provides a standing change management function for your Korean registrations. Every time your engineering, manufacturing, or quality team introduces a change, we assess its regulatory impact under Korean standards, classify the filing type, and manage the MFDS notification or re-approval process before the updated product enters the Korean market.
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.
- Product Change Log with regulatory impact assessment for every change submitted
- Change Classification Memo detailing the MFDS filing pathway chosen and rationale
- Complete MFDS Filing Package (change application or notification) for each change
- MFDS Submission Receipt and Approval Confirmation for each filed change
- Change Notification Compliance Calendar tracking pending approvals and follow-up deadlines
Shipping an Unapproved Change into Korea Is a Compliance Violation — Even if the Change Was Safe.
MFDS does not grant grace periods for unreported product changes. A device entering Korea with an unapproved design, software, or labeling change — even if the change itself poses no safety risk — is legally a violation of your product's registered specifications. The consequence is import suspension and potential license jeopardy. Leanabl's standing change management function eliminates this risk by ensuring every change is assessed and filed before the first unit ships.
Start Your Change Notification Management CoverageFrequently Asked Questions
Common questions about Korean medical device change notification requirements and how Leanabl's service works.