Journal of Acupuncture Research

  • 제32권4호
  • /
  • Pages.91-102
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  • 2015
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  • 2586-288X(pISSN)
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  • 2586-2898(eISSN)
대한침구의학회 (Korean Acupuncture & Moxibustion Medicine Society)
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한방의료기기의 미국 시장 진출을 위한 심사제도 소개

The registration and approval of Oriental Medical devices for the entry into U.S. market

  • 오지윤 (동국대학교 한의과대학 침구학교실) ;
  • 최유나 (동국대학교 한의과대학 침구학교실) ;
  • 조수정 (동국대학교 한의과대학 침구학교실) ;
  • 정찬영 (동국대학교 한의과대학 침구학교실) ;
  • 조현석 (동국대학교 한의과대학 침구학교실) ;
  • 이승덕 (동국대학교 한의과대학 침구학교실) ;
  • 김갑성 (동국대학교 한의과대학 침구학교실) ;
  • 김은정 (동국대학교 한의과대학 침구학교실)
  • Oh, Ji Yun (Department of Acupuncture & Moxibustion Medicine, College of Oriental Medicine, Dongguk University) ;
  • Choi, Yu Na (Department of Acupuncture & Moxibustion Medicine, College of Oriental Medicine, Dongguk University) ;
  • Jo, Su Jeong (Department of Acupuncture & Moxibustion Medicine, College of Oriental Medicine, Dongguk University) ;
  • Jung, Chan Yung (Department of Acupuncture & Moxibustion Medicine, College of Oriental Medicine, Dongguk University) ;
  • Cho, Hyun Seok (Department of Acupuncture & Moxibustion Medicine, College of Oriental Medicine, Dongguk University) ;
  • Lee, Seung Deok (Department of Acupuncture & Moxibustion Medicine, College of Oriental Medicine, Dongguk University) ;
  • Kim, Kap Sung (Department of Acupuncture & Moxibustion Medicine, College of Oriental Medicine, Dongguk University) ;
  • Kim, Eun Jung (Department of Acupuncture & Moxibustion Medicine, College of Oriental Medicine, Dongguk University)
  • 투고 : 2015.11.13
  • 심사 : 2015.11.30
  • 발행 : 2015.12.18
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초록

Objectives : The Oriental medical device industry is expected to continue to experience significant growth. It should increase its global market share rather than focusing on the domestic market. Countries around the world self-regulate their domestic market, so this study aims to aid in the development of a particular overseas market by introducing the U.S.(the largest market) medical device registration and approval process. Methods : For an understanding of the US medical device licensing process, we researched the relevant regulatory organization (FDA), the history, definition and classification of medical devices, the approval and 510(k) submission process related to substantial equivalence, IEC 60601-1 Edition 3, usability tests, and so on. Results : Medical devices in the United States are assigned to one of three regulatory classes: Class I, Class II and Class III, based on the level of control necessary to assure the safety and effectiveness of the device. If a company's device is classified as Class II and if it is not exempt, a 510k will be required for marketing. 1) A 510(k) is a premarket submission made to the FDA to demonstrate that the new device to be marketed is "substantially equivalent" to a legally marketed device (predicate device) 2) The IEC 60601-1 Edition 3 preparation process, which contains information related to usability, is expensive and time-consuming but a critical requirement. Conclusions : Although the U.S. market has high barriers to entry, access to this, large overseas market will encourage development of the Oriental medical device industry and commercial value enhancement is expected.

키워드

참고문헌

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