Transcription of 의료기기 등록허가 제도 (대만) - rapatcl.or.kr
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의료기기 등록허가 제도 (대만) - rapatcl.or.kr
/ ( ). 1.. - (Department of Health). - . (DOH) .. (MOEA) (BOFT). (import license) DOH . (pre-marketing registration approval) . - DOH (the Department of Health) . BOPA (Bureau of Pharmaceutical Affairs) . - . - DOH . , .. - .. DOH . USFDA 21(CFR) I, II, III .. HIV-1/2, HTLV-I/II, B , -A, -B . (IVD) 2002 12 . IVD . IVD . - 1 - - (Pharmaceutical Affairs Law) , (pre-market approval) .. DOH . (2006 4 12 ) , . 40 . 2.. , .. (DOH) .. (MOEA) (BOFT) (import license) DOH . (pre-marketing registration approval) . 3.. (Registration Certificate) . (Pharmaceutical Affairs Law) . , (pre-market approval) .. (case-by-case decision) . , 6 .. DOH (2006 4 12 ) , 40 . - 2.
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