Soonchunhyang Medical Device Clinical Research Center (herein referred to as Research Center) carries out in-depth researches regarding the total product life cycle of medical devices and provides training programs in aim for medical device regulatory harmonization.
Our research center,
designated as the Medical Device Safety Information Monitoring Center in 2013, has established an organized system to report abnormal cases and safety information. We have also been designated as the medical device ‘Center of Excellence’ by the APEC Regulatory Harmonization Steering Committee (RHSC) and have successfully co-hosted a pilot training program with the APEC Harmonization Center (AHC) in 2020.
Additionally, we participate in projects of the National Institute of Technology and Standards, which include developments of ‘International Standard for Emergency Use Approval and Post-marketing Safety Monitoring In-vitro Diagnosis Medical Devices in an infectious disease disaster’ and ‘An international standard for quality requirements of a clinical laboratory under the circumstance of EUA in vitro diagnostic devices use’.
We aim to correspond to the rapid changes in international regulations and provide up-to-date information through active researches and training programs.