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http://dx.doi.org/10.9718/JBER.2010.31.4.280

Preparation of guidance documents item by item for one-step evaluation and approval for Medical Devices  

Kim, Yong-Woo (Korea Food & Drug Administration)
Shin, Chae-Min (National Institute of Food and Drug Safety Evaluation)
Bang, Ji-Young (National Institute of Food and Drug Safety Evaluation)
Yi, Jung-Yeon (National Institute of Food and Drug Safety Evaluation)
Oh, Hyeon-Joo (National Institute of Food and Drug Safety Evaluation)
Bae, Woo-Jin (National Institute of Food and Drug Safety Evaluation)
Choi, Jin-Man (National Institute of Food and Drug Safety Evaluation)
Lim, Kyung-Mi (National Institute of Food and Drug Safety Evaluation)
Oh, Heon-Jin (National Institute of Food and Drug Safety Evaluation)
Kim, Mi-Young (Korea Food & Drug Administration)
Hur, Chan-Hoi (Korea Food & Drug Administration)
Kim, Hyung-Bum (Korea Food & Drug Administration)
Choi, Min-Yong (Korea Food & Drug Administration)
Kwak, Ji-Young (Korea Food & Drug Administration)
Kim, Su-Yeon (National Institute of Food and Drug Safety Evaluation)
Hwang, Sang-Yeon (National Institute of Food and Drug Safety Evaluation)
Youn, Hae-Suk (National Institute of Food and Drug Safety Evaluation)
Hong, Hye-Kyeong (National Institute of Food and Drug Safety Evaluation)
Ahn, So-Young (Korea Food & Drug Administration)
Lee, Chang-Hyung (National Institute of Food and Drug Safety Evaluation)
Jeong, Jin-Baek (National Institute of Food and Drug Safety Evaluation)
Koo, Ja-Jung (Korea Food & Drug Administration)
Kang, Se-Gu (Korea Food & Drug Administration)
Jung, Jae-Hoon (Korea Food & Drug Administration)
Lim, Kyoung-Taek (Korea Food & Drug Administration)
Lim, Chang-Keun (Korea Food & Drug Administration)
Kim, Min-Su (Korea Food & Drug Administration)
Lee, Seong-Hyi (Korea Food & Drug Administration)
Lee, Jae-Keun (Korea Food & Drug Administration)
Park, Ki-Jung (National Institute of Food and Drug Safety Evaluation)
Publication Information
Journal of Biomedical Engineering Research / v.31, no.4, 2010 , pp. 280-284 More about this Journal
Abstract
Approvals of medical device increase every year as industry of medical device grows. Therefore KFDA keeps trying to improve approval systems. However, the firms of medical device are in trouble due to regulation amendment, a firm of small size, exchange of the person in charge. The staffs of KFDA increase their work load because applicants of approval of medical device aren't used to writing of document. Therefore the firm of medical device in business have a long term. KFDA develops eight guidance document item by item for one-step evaluation and approval for Medical Devices because applicants of approval of medical device write documents easily. KFDA reviewer can carry on quick reviewing in use of this eight guidances. This guidance are improved on satisfaction of applicants of approval of medical device.
Keywords
Medical Device; one-step evaluation; approval; guidance document;
Citations & Related Records
Times Cited By KSCI : 2  (Citation Analysis)
연도 인용수 순위
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