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의료기기 등록허가 제도 (중국) - rapatcl.or.kr

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/ ( ). 1. . - (SFDA) . - , . , . . . . - . , . - (SFDA). - . 1 . 2 . . ; , ; . 3 , . . - . - 2, 3 , . . . - . - . - . - 1 - - , , . - . - . - . 2. . . . , 2006 . . 2006 12,000 , 2005 . 1790 . . , , , . , , , . . 80% . - 2 - . . , NDRC( ) . , , . , (MOH) , SARS . , . . , . , R&D . , . . , , . , . , . . 3. . . (SFDA) . SFDA . . . . . . - 3 - . SFDA . SFDA . . . . . (DMD) . DMD . . . (1) . - , , . - . - . (2) . - , , . - . - . (3) . - . - . - 4 - (4) . - . - . . (CMDE). (1) . (2) 3 . (3) , , . . (4) . (5) SFDA , 3 . . (6) 3 . 4. . - . - . - . - , , . - . - . - . 5. . . . , . , , , ; . - 5 - , , . . , . - , , , , . - , , , , . - , . - . . . (1) . , 3 . . < > < >. . (2) . 1, 2, 3 , 1 . 3 . 1 . 2 . 3 ; , ; , . . 6. . . . , , . . . . - ( ). - , ( ). - 6 - - ( ). - , ( ). . . 16 2004 8 9 . , 9 , 56 12 , . . . , . . . . - . - ( : 4 ). - . . . , , , . (SFDA).

- 4 - b< · (sfda 기술기구 국장 국가약전위원회 의약품인증센터 의료기기심사센터 의약품심사센터 의약품불량반응검사센터

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