ABOUT ICMC

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

History & CI

History

History

~2022

  • - Technical support designated by EU UK Agent (UKCA Agent)
    - ISO15378 Certification support for pharmaceuticals, cosmetics, and medical device packaging materials
    - Recognition of IAC Global and Educational Institutions (ISO International Review Board, GMP Internal Review Board, RA Education)
    - European CE/IVDD (COVID-19-RT-PCR, Immunochemical Reagent) certification and AR agent
    - In vitro diagnostic medical device license and GMP certification (Covid-19) permission for multiple items completed
    - Korea Industrial Technology Promotion Association / Establishment of an affiliated research institute
    - Clinical evaluation of medical devices for in vitro diagnosis and publication of licensed textbooks
    - The head of the Seoul Regional Food and Drug Administration/Acquired a medical device import business license
    - The head of the Seoul Regional Food and Drug Administration/Approval of GMP suitability for medical devices
      (item group: internal functional containers, syringes, and needles)
    - A strategic agreement for ISO certification with the U.S. Institute of Certification
    - The head of the Seoul Regional Food and Drug Administration acknowledges the suitability of medical device GMP
      (Item group: Ingredients for dental treatment)
    - Medical devices such as the United States, Europe, China, and Japan (3rd Part Holder)
    - Starting overseas export of medical devices (USA, Japan, China, Europe)
    - Korea International Trade Association Trade Business Registration
    - Performing government projects linked to industry-academic research institutes for clinical permits for new medical devices
    - International ISO Examiner Curriculum and GMP Internal Examiner Course are held
    - First registration of PMDA (Stem Cell Cosmetics) cosmetics by the Ministry of Health, Labor and Welfare of Japan
    - “ISO 10004 Customer Satisfaction Management System” and “ISO/IEC 27701 Privacy Information Management System” certified

~2010

  • - A clinical trial agreement with the Medical Device Clinical Center of Korea University Guro Hospital
    - Osaka, Japan, and Tokyo (Korea Medical Device License, GMP Certification) held five seminars
    - Strategic MOU of CA Agent specializing in in vitro diagnostic reagents, medical devices, and cosmetics (FDA) in the United States
    - Strategic MOU with European EUAR (In Vitro Diagnostic Reagent, Medical Device) German agents
    - Strategic MOU of Beijing agents specializing in medical devices and cosmetics (NMPA) in China
    - Japan's PMDA (Medical Device, Cosmetics) Tokyo Agent Strategic MOU
    - Registration of QIA licensing agency for animal medical devices
    - Technical support for GMP certification under the Medical Device Act
    - Registered with the Korean Cosmetics Association's Chinese Cosmetics Sanitation Permit Consulting Institution
    - ICMC-KTR (Korea Research Institute of Chemical Testing) signed an MOU for its entry into Japan
    - Selection of an organization that supports the acquisition of overseas standard certification under the supervision of the Small and Medium Business Administration
    - Selection of agencies to carry out export support-based utilization projects (export vouchers)
    - Korea Cosmetics Association PMDA held a seminar on how to target Japanese cosmetics (after-production)
    - European animal-derived medical device filler CE/MDD CE/IVDD certification (Class 3) technical support
    - Transition to a corporation of International Certification Management Center Co., Ltd.
    - ISO13485& ISO9001 Revised Education Seminar to be held
    - Korea Technology Commercialization Promotion Association Daegu Branch holds a seminar on how to target medical device licenses

~1998

  • - Technical support for product certification by the Korea Standards Association (KS)
    - KS certification and ISO certification by the Korea Quality Certification Agency (KQA)



CI


  • CI

    Company : CI

  • CI

    Company : Nameplate

1
ICMC provides technical support for experts with respect for human beings (domestic RA license/global RA license).
2
ICMC provides technical support in the high-tech medical health field, support for the latest standards, and support for RA education & training support.
3
ICMC is responsible licensing (dedicated consultant), post-certification management, and technical support for international revised standards.
4
ICMC provides expertise in strategic corporate management system management (GMP, ISO International Standard).
5
ICMC performs the Korean import agency (3rd Party Holder) and global agent service.
6
ICMC plays the role of an overseas player by establishing a global network.