|
|
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 & ITC CERT - 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
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
|