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선별적 적용을 통한 의료기기 공급내역보고 제도 개선 연구

Other Titles
 A Study on the Improvement of the Reports on Details of Supply of Medical Device System Through Selective Application 
 정현주  ;  임수연  ;  김주완  ;  장원석  ;  권병주 
 Journal of Biomedical Engineering Research (의공학회지), Vol.44(05) : 315-323, 2023-10 
Journal Title
Journal of Biomedical Engineering Research(의공학회지)
Issue Date
Reports on details of supply of medical device ; Selective application ; Therapeutic materials ; Secondhand medical devices
The objective of this study is to identify the selective application targets for reporting on details of supply of class 1 and 2 medical devices as part of the improvement of the reports on details of supply of medical device system, and to analyze its effectiveness. Therapeutic materials covered by health insurance and secondhand medical devices were chosen based on the transparency of health insurance coverage and the management of medical device distribution. As a result, approximately 85% of groups can be excluded from the reporting requirements compared to reporting all items under Class 1 and 2 medical devices. This is expected to enhance the efficiency of supply reporting tasks. Additionally, the information on supply details managed by the regulatory authority can be utilized for statistical analysis and periodic monitoring, serving as fundamental data for the development of medical device-related policies and research in the field of medical devices.
Files in This Item:
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Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Medical Engineering (의학공학교실) > 1. Journal Papers
Yonsei Authors
Kwon, Byeong-Ju(권병주) ORCID logo https://orcid.org/0000-0001-9916-0546
Chang, Won Seok(장원석) ORCID logo https://orcid.org/0000-0002-4925-3549
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