Korea Class I Express
Class I Should Be Fast. Without the Right Setup, It Won't Be.
When Korea Class I Express Is the Right Fit.
Three scenarios where foreign manufacturers lose time or control on Korea's fastest pathway.
First-Time Korea Entry
First-time Korea entry with a Class I device — MFDS notification handled end-to-end.
Multi-Product Class I Portfolio
Three or more Class I devices filed in parallel under one program — not sequential 6-month projects.
Distribution-Independent License Control
License held by a neutral regulatory partner — not your distributor.
Every Deliverable Required to Hold a Class I License in Korea.
Three coordinated services that produce and hold a Class I license.
- / 01
MFDS Product Code Confirmation
The exact MFDS classification code — top cause of Class I deficiency notices.
- / 02
Notification Pathway Eligibility Memo
Written confirmation your device qualifies for the notification (신고) pathway.
- / 03
Comparable Product Analysis
Korean-market device mapping when MFDS expects a substantial-equivalence reference.
- / 04
Submission Strategy Brief
Documents required, MFDS reviewer expectations, projected timeline.
Predictable Class I Outcomes for Foreign Manufacturers.
34-Day Class I Clearance for a European Diagnostics Firm
4-Product Parallel Filing for a North American OEM
Frequently Asked Questions
Common questions answered.
Your MFDS Class I Product Registration Certificate, Delivered Without Avoidable Delays.
Speed comes from correct scoping and clean execution — not from rushing the wrong submission.
Speak with a Korea Registration Specialist Today