�닚紐⑦떚諛붿퐫由ъ븘�뒗 紐⑦떚諛� �젣議곗궗 Establishment labs媛� 誘멸뎅 �떇�뭹�쓽�빟援�(FDA)�쓣 �룷�븿�븳 5媛� 洹쒖젣湲곌���쓣 以��닔�븯�뒗 �쓽猷뚭린湲� �떒�씪�떖�궗 �봽濡쒓렇�옩(MDSAP)�쓽 �씤利앹쓣 諛쏆븯�떎怨� 諛쒗몴�뻽�떎.
紐⑦떚諛� �젣議곗궗 Establishment labs�뒗 泥⑤떒 �쓽猷뚭린湲� �젣議곗떆�꽕�쓣 媛뽰텣 Coyol Free Zone Business park(肄붿뒪���由ъ뭅)�뿉 �엯�젏�빐�엳�떎.
MDSAP�뒗 Medical Device Single Audit Program�쓽 �빟�옄濡� �샇二쇱쓽 TGA, 釉뚮씪吏덉쓽 ANVISA, 罹먮굹�떎�쓽 HEALTH, �씪蹂몄쓽 蹂닿굔 蹂듭��遺� (MHLW)��� �쓽�빟�뭹 �쓽猷뚭린湲� 醫낇빀湲곌뎄(PMDA) 諛� 誘멸뎅 FDA瑜� �룷�븿�븳 援��젣 �쓽猷뚭린湲� 洹쒖젣�떦援��쓽 �뿰�빀�뿉 �쓽�빐 �꽕由쎈맂 �쓽猷뚭린湲� �떒�씪�떖�궗 �봽濡쒓렇�옩�씠�떎.
�젣議곗뾽泥대뒗 MDSAP�쓽 �봽濡쒓렇�옩�쓣 �넻�빐, 怨듭씤�맂 �젣 3�옄�쓽 �떖�궗湲곌뎄��� 怨꾩빟�쓣 留븐뼱 誘멸뎅 FDA瑜� �룷�븿�븳 愿��븷�떦援��쓽 愿��젴洹쒖젣�뿉 ����븳 �슂援ъ궗�빆�쓣 異⑹”�떆�궎�뒗 �떒�씪�떖�궗瑜� �닔�뻾�븷 �닔 �엳�쑝硫�, �씠�뒗 MDSAP �떖�궗 蹂닿퀬�꽌瑜� 誘멸뎅 FDA�쓽 EIR(Establishment Inspection Reports) ����떊 �씤�젙�븳�떎�뒗 寃껋쓣 �쓽誘명븳�떎.
�씠�뿉 ����빐 紐⑦떚諛� 愿�怨꾩옄�뒗 ��쒕え�떚諛� 蹂댄삎臾쇱�� 援��궡 �떇�뭹�쓽�빟�뭹�븞�쟾泥섏뿉�꽌 �닔�엯 諛� �뙋留ㅼ듅�씤�쓣 諛쏆�� 8媛쒖쓽 蹂댄삎臾� �뾽泥� 以� �븯�굹�씠硫�, 誘멸뎅 FDA瑜� �룷�븿�븳 5媛쒖쓽 洹쒖젣湲곌���씠 以��닔�븯�뒗 MDSAP�쓽 �씤利앹�� 紐⑦떚諛� �깮�궛 怨듭젙�쓽 �븞�쟾�꽦�쓣 �엯利앺븷 �닔 �엳�뒗 �옄猷뚭�� �맆 �닔 �엳�쓣 寃꺿�앹씠�씪怨� 留먰뻽�떎.
紐⑦떚諛붾뒗 援��궡 �떇�뭹�쓽�빟�뭹�븞�쟾泥섏쓽 2016�뀈 6�썡 �닔�엯 諛� �뙋留ㅽ뿀媛�瑜� �쉷�뱷�븯����쑝硫�, �씠瑜� �쐞�빐�꽌�뒗 �젣�뭹�쓽 �꽦�뒫�뿉 愿��븳 �뜲�씠�꽣肉먮쭔 �븘�땲�씪 �깮臾쇳븰�쟻 �븞�쟾�꽦 �뀒�뒪�듃, �엫�긽�떆�뿕�뿉 愿��븳 �뜲�씠�꽣 �벑�쑝濡� �젣�뭹�쓽 �븞�쟾�꽦怨� �쟻�빀�꽦�쓣 �뮮諛쏆묠 �븷 �닔 �엳�뒗 �옄猷� �삉�븳 �젣異쒗빐�빞 �븳�떎.
�씠�뿉 愿�怨꾩옄�뒗 ��쒖븵�쑝濡� �닚紐⑦떚諛붿퐫由ъ븘�뒗 �젣�뭹 �깮�궛�옄肉먮쭔 �븘�땲�씪 理쒓퀬 寃쎌쁺吏꾧퉴吏� 湲곗뾽�쓽 �뻾�룞媛뺣졊�쓣 以��닔�븯�뿬, �냼鍮꾩옄�뿉寃� �븞�쟾�븯怨� 誘우쓣 �닔 �엳�뒗 理쒖긽�쓽 �젣�뭹怨듦툒�쓣 �쐞�빐 理쒖꽑�쓣 �떎�븷 寃� �씠硫�, �젣�뭹�쓽 �삱諛붾Ⅸ �젙蹂댁쟾�떖�쓣 �쐞�빐 �냼鍮꾩옄��� �뒛 �냼�넻�븯�뒗 湲곗뾽�씠 �릺寃좊떎��앷퀬 �쟾�뻽�떎.
�뵒吏��꽭湲고쉷��� �씠�꽭�뿰 lovok@kmib.co.kr
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