International Chamber of Commerce

ICC

ICC

ICC(In-Country Caretaker) service is on behalf of overseas manufacturers in the medical equipment/medical sector item licensing management and import duties in Korea.
We secure business stability by following overseas medical devices for entering the Korean market and managing the Korean market.

Consulting subject
  • Overseas companies looking for manufacture and import and sell medical devices under Article 6 or 15 of the Medical Devices Act
  • Overseas companies that want to export medical device to Korea or consign medical device licenses in Korea
Detail of consulting contents
  • Importing item approval under Article 6, 7 and Enforcement Regulations of the Medical Device Act, etc. (MFDS)
  • KGMP certification under Article 6 of the Enforcement Regulations of the Medical Device Act (MFDS)
  • Clinical test under Article 10 of the Medical Devices Act and Article 20 of the Enforcement Regulations of the Medical Device Act
  • Insurance registration under Article 10 of the Rules on the Standards of the National Health Insurance Medical Care Benefit
  • Post-management (Reporting side-effect, safety and re-evaluation/examination)
  • Evaluating new medical technology
  • License Holding
  • Reporting and taking action on side-effect cases in Korea
  • The task for customs clearance of imported products through customs in Korea
  • Consulting for sale in the Korean market