Ngomhla wama-25 kuCanzibe, ngo-2017, uphando olusebenzisa ubushushu olusetyenziswa kwezonyango oluzimeleyo lwaze lwaphuhliswa yiShenzhen Med-linket Medical Electronics Co., Ltd. luphumelele isiqinisekiso seCanadian CMDCAS
Inxalenye yesithombe-skrini sesatifikethi sethu se-CMDCAS
Kuxelwe ukuba isiqinisekiso sezixhobo zonyango saseKhanada sahlukile kwisiqinisekiso sase-US (FDA) esiphathwa ngokupheleleyo ngurhulumente kubhaliso lwemveliso kunye nophononongo lukarhulumente kwindawo (uphononongo lwe-GMP), sahlukile nakwisiqinisekiso saseYurophu (CE) esiqinisekiswe ngokupheleleyo ngumntu wesithathu, i-CMDCAS isebenzisa inkqubo esemgangathweni eqinisekiswe ngurhulumente kunye nophononongo lomntu wesithathu. Umntu wesithathu kufuneka aqinisekiswe yiCanadian Medical Device.
Zonke izixhobo zonyango ezithengiswa kwimarike yaseKhanada kufuneka zifumane imvume kwiSebe leMisebenzi yezoNyango laseKhanada – iSebe lezeMpilo laseKhanada, nokuba zenziwe apha ekhaya okanye zingeniswe kwamanye amazwe.
Kwinkqubo yophicotho-zincwadi lwe-CMDCAS yaseKhanada, ubungqina kufuneka buhlangabezane neemfuno zenkqubo yolawulo lomgangatho esemgangathweni ye-ISO 13485/8:199 okanye i-ISO 13485:2003 kwaye kufuneka buhlangabezane nenqanaba elifunekayo kwiMimiselo yeZixhobo zonyango zaseKhanada.
Ukuba ufuna ukuphumelela kwisatifikethi sezixhobo zonyango zaseKhanada, izixhobo zonyango kufuneka zibe kumgangatho ophezulu kunye netekhnoloji kwaye zikwazi ukumelana nokuhlolwa okuhlukeneyo. Impumelelo ethe tyaba kwisatifikethi seCMDCAS saseKhanada iqinisekisile umgangatho wethu ogqwesileyo wobuchwephesha kwiprobe yethu yobushushu kwakhona.
Iprobe yoBushushu boMngxunya
Iprobe yoBushushu boMzimba
Zinikele ekuziphandeni nasekuphuhliseni, ekuveliseni nasekuthengiseni izixhobo zonyango ezikumgangatho ophezulu, sizimisele ngokwenene!
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Ixesha leposi: Meyi-26-2017