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KMID : 0615720150320040091
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Jouranl of Korean Acupuncture and Moxibustion society
2015 Volume.32 No. 4 p.91 ~ p.102
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The registration and approval of Oriental Medical devices for the entry into U.S. market
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Oh Ji-Yun
Choi Yu-Na
Jo Su-Jeong
Jung Chan-Yung
Jo Hyun-Seok
Lee Seung-Deok
Kim Kap-Sung
Kim Eun-Jung
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Abstract
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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.
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KEYWORD
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Oriental medical device, FDA, 510(k), Medical device regulation and approval
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