Service
Product Registration with MFDS (Ministry of Food and Drugs Safety)
Pre-market approval / Pre-market notification
- Class 1 to 4 Medical Devices
- Combination Products (device combined with drug)
- In-Vitro Diagnostic Products
Korea GMP certification
Reimbursement Approvals
GIP (Good Import Practice) system construction for Korean distributors
MFDS Post Market Compliance Consulting Services
- Tracking
- Voluntary recall/adverse event/safety alert reporting
- Re-examination
- Re-evaluation
Import Device Approval Certificate Holding service (called ‘In-Country Caretaker service’) for foreign device manufacturers that have no legal entity in Korea