DOMESTIC RA

ICMC (International Certification Management Center Co., Ltd.)

3rd Party Holder

3rd Party Holder Service

Overseas medical device manufacturers without local branches must designate an agent in Korea to register medical devices with the Ministry of Food and Drug Safety (MFDS). As an agent with an import business permission, we can help you with the management of medical device registration and compliance with Korean Good Manufacturing Practice (KGMP) requirements.




ICMC Consulting work

1
Item declaration/certification/permission application
2
Apply for KGMP certification
3
Quality manager role
4
Korea customs clearance affairs
5
Follow-up management report
6
Responsible for liaison with MFDS
7
The role of major importer under license
8
Submit an application for insurance benefits (HIRA)



Benefits of ICMC's 3rd Party Holder Service

Most overseas manufacturers designate distributors as medical device registration and importers. In most cases, overseas manufacturers do not value the fact that distributors manage medical device registration. In this case, foreign manufacturers may have problems when changing distributors in the future. As an independent third-party holder, we allow manufacturers to manage distributors.