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
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- 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
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- 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