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KMID : 1137820100310040280
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의공학회지
2010 Volume.31 No. 4 p.280 ~ p.284
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Preparation of guidance documents item by item for one-step evaluation and approval for Medical Devices
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Kim Yong-Woo
Shin Chae-Min
Bang Ji-Young
Lee Jung-Yeon
Oh Hyeon-Joo
Bae Woo-Jin
Choi Jin-Man
Lim Kyung-Mi
Oh Heon-Jin
Kim Mi-Young
Hui Chan-Hoi
Kim Hyung-Bum
Choi Min-Yong
Kwak Ji-Young
KIm Soo-Yeun
Hwang Sang-Yeon
Youn Hae-Suk
Hong Hye-Kyeong
Ahn So-Young
Lee Chang-Hyung
Jeong Jin-Baek
Koo Ja-Jung
Kang Se-Gu
Jung Jae-Hoon
Lim Kyoung-Taek
Lim Chang-Kuen
Kim Min-Su
Lee Sung-Hee
Lee Jae-Keun
Park Ki-Jung
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Abstract
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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.
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KEYWORD
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Medical Device, one-step evaluation, approval, guidance document
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FullTexts / Linksout information
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Listed journal information
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