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Post-Approval Maintenance
Approved products still require ongoing control of changes, renewals and import and distribution records.
When a review helps
Prepare renewal and maintenance schedules
Reconcile authorization records with operations
When is this service useful?
Changes to the manufacturing site, materials, models, intended use or test specifications may require a prior regulatory procedure. Late identification can affect supply timing and maintenance of the authorization.
Key areas of review
Change assessment
Review how product and manufacturing-site changes affect the authorization.
Renewal management
Track authorization and KGMP validity periods and preparation milestones.
Post-market response
Support safety information, complaints, recalls and authority requests.
Prepare for your review
- Current authorization and change history
- Manufacturer change notification
- Current labeling and IFU
- KGMP and quality records
How We Work
Receive change notice
Collect manufacturer change information early.
Assess impact
Determine implications for authorization, KGMP, labeling and importing.
Complete the procedure
Prepare the required change application and evidence.
Maintain history
Record approval results and effective dates.
Keep changes traceable
Compare the current authorization, proposed changes and supporting documents to organize follow-up checks and schedules.
The specific scope and deliverables are agreed after product and evidence review.
Frequently Asked Questions
What should we prepare for an initial discussion?
Product information, intended use, manufacturing details, approvals and available testing evidence.
When can timing be estimated?
After likely classification and material evidence gaps have been reviewed.
MFDS medical-device regulations · MFDS medical-device approval process · Content baseline · Check current requirements for the specific product
CONSULTATION
Start a consultationClarify the Korean regulatory pathway for your product.
Attach what you have and we will reply by email after reviewing it. You do not need a complete set of documents.