Articles - Medical Device Info journal List

※ Medical Devices Seminar


2011 Year

  • 2011.06 - Conformity Assessment of Medical Devices (CE & KFDA) & Advanced Medical
                             Devices    -    English
  • 2011.04 - Introduction of Institute for Testing and Certification & ASIA ITC    -    English
  • 2011.04 - Conformity Assessment of Medical Devices (CE & KFDA)    -    English
  • 2011.04 - Conformity Assessment for Advanced Medical Devices    -    English
  • 2011.04 - Analysis of the Korean Medical Device Market    -    English
  • 2011.04 -Comparison between the STED of GHTF and the Technical Document of KFDA
                             -    English
  • 2011.04 - Concurrent preparation for the conformity assessment of KFDA, CE and FDA
                             -    English
  • 2011.04 - Medical Device Regulatory in KOREA    -    English
  • 2011.04 - Requirements for Medical device importer and Medical device registration
                             in KOREA    -    English
  • 2011.04 - Comparison between KFDA and CE for Quality system    -    English

2010 Year

  • 2010.02 - Trend in the Medical Device Certification Market    -    Korean  English
  • 2010.02 - Examples of Class 2 Medical Device Certification    -    Korean  English
  • 2010.02 - Concurrent Certification of PAL and CE/MDD    -    Korean  English
  • 2010.02 - Concurrent Certification of PAL and FDA    -    Korean  English
  • 2010.02 - Conformity Assessment Procedures of Pharmaceutical Affairs Law (PAL)
                             of Japan and CE/MDD    -    Korean  English
  • 2010.02 - Conformity Assessment of Quality Management System    -    Korean  English

2009 Year

  • 2009.04 - Conformity assessment of In-vitro Diagnostic Medical Device(93/42/EC)    -    English
  • 2009.04 - Borderline Issues; MDs/IVDs/Medicinal Products    -    English
  • 2009.04 - Conformity assessment of Advanced Medical Devices    -    English
  • 2009.04 - CE Marking for Own Brand Labelled Medical Devices    -    English
  • 2009.04 - Conformity Assessment of Medical Device Dirctive(93/42/EEC)    -    English
  • 2009.04 - Amendment to the Medical Device Directive (93/42/EEC)    -    Korean  English
  • 2009.02 - Medical Device Regulations    -    Korean  English
  • 2009.02 - Quality Control with Quality Management System    -    Korean  English

2008 Year

  • 2008.11 - Comparison between CE/MDD and FDA 510k    -    Korean   English
  • 2008.11 - Introduction of premarket notification(510k)    -    Korean   English

※ Medical Devices Journal

    KTL(Korea Testing Laboratory) - Medical Device Information

    published by Medical device information & technical support center in Korea Testing Laboratory
    These articles listed below, are properties of Medical device information & technical support center in Korea Testing Laboratory
  • No. 58 2010 Year    -    Korean   English
    Official letter according to a guidance on the revision of Medical Device Directive(93/42/EEC)
  • No. 57 2010 Year    -    Korean   English
    Strategy for entrance to Japanese medical device market and methodology for competitiveness reinforcement
  • No. 53 2009 Year    -    Korean   English
    Current state and future of Chinese medical device industry

Medi Journal

    These articles listed below, are properties of Medi journal
  • No. 06 2011 Year    -    Korean   English
    Medical Device Regulatory Requirements for Mexico
  • No. 05 2011 Year    -    Korean   English
    Medical Device Regulatory Requirements for Brazil
  • No. 04 2011 Year    -    Korean   English
    CE certificate of high-tech medical devices containing medicine
  • Medi Journal Special Edition    -    Korean   English
    Conformity Assessment Procedures by SFDA
  • Medi Journal Special Edition    -    Korean   English
    Pharmaceutical Affairs Law (PAL) and Conformity Assessment Procedures
  • Medi Journal Special Edition    -    Korean   English
    European Conformity Assessment Procedures of Medical Devices
  • Medi Journal Special Edition    -    Korean   English
    Product Certification by FDA
  • No. 02 2011 Year    -    Korean   English
    Effective clinical data to prepare CE certification
  • No. 01 2011 Year    -    Korean   English
    GOST-R certificate of medical device for entrance to Russia market (2)
  • No. 12 2010 Year    -    Korean   English
    GOST-R certificate of medical device for entrance to Russia market (1)
  • No. 11 2010 Year    -    Korean   English
    Comparison between FDA QSR and ISO 13485
  • No. 09 2010 Year    -    Korean   English
    Certificate of IVD (In-vitro Diagnostic Device)
  • No. 08 2010 Year    -    Korean   English
    Guidance on the medical device registration of SFDA (2)
  • No. 07 2010 Year    -    Korean   English
    Guidance on the medical device registration of SFDA (1)
  • No. 06 2010 Year    -    Korean   English
    Understanding of Chinese medical device market and SFDA registration
  • No. 04 2010 Year    -    Korean   English
    Will we just leave the world’s second largest medical device market? (2)
  • No. 03 2010 Year    -    Korean   English
    Will we just leave the world’s second largest medical device market? (1)
  • No. 02 2010 Year    -    Korean   English
    Corresponding strategy according to the revision of medical device directive
  • No. 01 2010 Year    -    Korean   English
    CE certificate of high-tech medical devices
  • No. 10 2009 Year    -    Korean   English
    Control of medical devices by FDA

Korea Medical Devices Industry Association

    These articles listed below, are properties of Korea Medical Devices Industry Association
  • No. 62 2010 Year    -    Korean   English
    CE certificate of high-tech medical devices for entrance to the overseas market