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 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.
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.
Service specification
Korea Change Notification Management
Leanabl maintains a complete, audit-ready change management record for your Korean registrations — ensuring every product update is documented, filed, and confirmed with MFDS.
Request assessmentUnreported product, software, labeling, or site changes can trigger Korean import suspension — regardless of whether the change affected safety or performance.
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
Frequently Asked Questions
Common questions about Korean medical device change notification requirements and how Leanabl's service works.