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A New Policy Study on Technical Document Review Changes and User-Centric Medical Device Advertising

Journal of Biomedical Engineering Research 2021년 42권 1호 p.7 ~ 17
안대익, 유규하,
소속 상세정보
안대익 ( Ahn Dae-Ik ) - Sungkyunkwan University SAIHST Department of Medical Device Management and Research
유규하 ( Ryu Gyu-Ha ) - Samsung Medical Center Office of R&D Strategy & Planning

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.

키워드

Medical device advertisement; Medical device technical document; Misleading advertisement; Autopoiesis; Stakeholder I

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