In-Country Caretaker Service(ICC)
ICC service refers to performance of various tasks on behalf of overseas medical device manufacturers as their Korea license holder. Through our ICC service, overseas manufacturers can secure local representation through MDREX without having to make significant investments for a local branch. This allows them to focus on sales and marketing activities while MDREX takes care of the complex product approval and management tasks.
MDREX's ICC service is an effective solution for initial market entry and expansion of overseas manufacturers, as MDREX takes the lead in product import and supply processes while allowing for direct financial transactions between overseas medical device companies and their local distributors in Korea.
Product License & Reimbursement
- • Product license (approval / certification / notification) and amendment notification
- • KGMP certification
- • Product license holder and KGMP certification holder
- • Reimbursement listing
- • New Health Technology Assessment / Deferred Assessment or Innovative Health Technology Designation
Import & Customs Clearance
- • Order processing and placement
- • Customs clearance declaration and import documentation
- • Inbound / outbound inspection and documentation
- • Warehousing leasing and QC management
Sales / Marketing & Post-Market Surveillance
- • Non-conforming product management
- • Adverse event reporting and corrective actions
- • Product recall
- • Local distributor sourcing
- • Fair competition compliance
- • Other marketing support services