Journal of Biomedical Engineering Research (대한의용생체공학회:의공학회지)

The Korean Society of Medical and Biological Engineering (대한의용생체공학회)
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A New Policy Study on Technical Document Review Changes and User-Centric Medical Device Advertising

사용자 중심의 의료기기 광고를 위한 기술문서 심사 변경의 새로운 정책 연구

  • Ahn, Dae Ik (Department of Medical Device Management and Research, SAIHST, Sungkyunkwan University) ;
  • Ryu, Gyu Ha (Department of Medical Device Management and Research, SAIHST, Sungkyunkwan University)
  • 안대익 (성균관대학교 삼성융합의과학원 의료기기산업학과) ;
  • 류규하 (성균관대학교 삼성융합의과학원 의료기기산업학과)
  • Received : 2020.11.05
  • Accepted : 2021.01.19
  • Published : 2021.02.28
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Abstract

In the case of domestic medical device advertisements, it is possible to proceed with the advertisement after medical device certification, and pre-deliberation is possible based on the medical device technical document. However, there are some medical device advertisements that stakeholders in administrative procedures have no choice but to misunderstand in customs and laws that do not consider users. In addition, medical equipment and the pre-deliberation system were judged to be unconstitutional, and unconstitutional decisions were made in accordance with the principle of prohibiting pre-censorship based on the Constitution. This is because in domestic medical device advertisements, structural contradictions and user damage occur in the central structure of each stakeholder. It is necessary to reestablish stakeholder relationships, increase water solubility from customs and laws, and seek new policy proposals. In this study, we reestablish relationships with stakeholders by applying the Autopoiesis theory, and present the grounds and directions that can prevent hype and misidentified advertisements through the establishment of user-centered policies, and the measures to be taken by the Constitutional Court unconstitutional decision.

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