| 치의학분야 3D 프린팅 기술이 적용된 의료기기의 인·허가전략과 과제 |
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신은미1, 양승민2 |
1성균관대학교 삼성융합의과학원 의료기기산업학과
2성균관대학교 삼성융합의과학원 의료기기산업학과 |
| Licensing strategies and tasks for medical devices utilizing 3D printing technology in dentistry |
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Eun Mi Shin1, Seung-Min Yang2 |
1Department of Medical Device Management and Research, Samsung Advanced Institute for Health Sciences & Technology(SAIHST), Sungkyunkwan University
2Department of Medical Device Management and Research, Samsung Advanced Institute for Health Sciences & Technology(SAIHST), Sungkyunkwan University |
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| Abstract |
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3D printing technology supporting the specific patient medical services is actively being implemented in dentistry. The purpose of this study is to introduce the legal and institutional considerations to the medical practitioners in dentistry who must observe when they manufacture medical devices using 3D printers, and to provide a ways to activate and enhance their utilization in the domestic approval point of view for medical devices. Through the public data of government agencies and related organizations, the statutory system and compliance matters related to the manufacture of 3D printing medical devices have been examined and reviewed for the government's improvement efforts. Through the study, the government has been actively improving the system and making policy, but the active interest and participation of medical professionals and related workers are continually required to solve the problems which are scattered. 3D printing technology is expected to be more frequently utilized in the field of dentistry in near future. Therefore, it is essential to establish measures to improve the regulation through continuous cooperation with the related ministries with the long-term point of view enhancing smooth entry to the market for the medical devices by taking data from the continued research. |
| Key Words:
3D Printing Technology;Medical Device Regulation;Dental Field;Custom-made Device; |
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