Sinikezela ngeenkonzo zokumisa iingcali zezixhobo zonyango kunye nezisombululo.
Funda ngokugqithisileyo
Iqela (le-KDL) lasekwa ngo-1987, ikakhulu lizibandakanya kwimveliso, i-R & D, ukuthengisa kunye nokurhweba ngesixhobo sonyango. Siyinkampani yokuqala epasisa isiqinisekiso se-CSDC kwishishini lezonyango ngo-1998 kwaye sifumana isatifikethi se-TUV kwaye saphumelela i-FDA yaseMelika kuPhicotho-zincwadi ngokulandelelayo. Ngaphezu kweminyaka engama-37, iqela le-KDL lalidwelwa ngempumelelo kwiBhodi ephambili yeShanghai nge-2016 Njengomvelisi wesixhobo sonyango, i-KDL inokubonelela ngoluhlu olubanzi lweemveliso zibandakanya isirinji, inaliti, i-tubings, izixhobo zokungenelela, izixhobo zonyango, izixhobo zonyango lwezilwanyana njlnjl.
IQELA LOKUGQIBELA LWEZOBUCHWEPHESHE KOLUNTU ZEZIFUNDO ZEEMFUNDO NOKUFUMANEKA KUNYE NOKUFUMANEKA KWEENKCAZO, Imvume ye-FDA, i-ISO13485, i-TGA kunye neMdandu. Ezi nkcazo-nkcukacha ziqinisekisa abathengi kunye nabathengi ukuba izixhobo zezonyango zenziwa ngokwemigangatho yesiseko kunye nezikhokelo, ziqinisekisa ukhuseleko lwabo nempumelelo.
Izixhobo zezonyango ezinesatifikethi esifunekayo zisaziwa kwihlabathi liphela, oko kuthetha ukuba abavelisi banokuzithengisa iimveliso zabo kwihlabathi jikelele. Ngokufumana iziqinisekiso ezifunekayo, iqelana lezebunqwanqwa lifumana ithuba lokhuphiswano ngaphezu kwabakhuphisana nabo. Ukuthobela le migangatho kunika abathengisi, ababoneleli bezempilo kunye nabasebenzisi bokuphela Ngaba ukuzithemba ukuba izixhobo zezonyango zikhuselekile, ziyasebenza kwaye zinokuthenjwa.
IQELA LOKUGQIBELA Njengabavelisi besixhobo sezonyango esiqinisekisiweyo banciphisa umngcipheko wemveliso ukhumbula, amabango oxanduva ngenxa yokungathobeli. Inkqubo yokufumana isatifikethi ibandakanya ukuvavanywa komgangatho wokuqinisekisa ukuba abavelisi bavelisa izixhobo zezonyango ezihlangabezana noyilo lwemveliso olumiselweyo, uphuhliso kunye nemigangatho yokwenza imveliso.
Iqela elinobubele ibiligama elithenjiweyo kwimveliso yezonyango elingana ishumi leminyaka. Uyilo oluyintsha osetyenziselwa ukwenza izixhobo zalo lwenze ukuba inkampani inyanzelwe ukuba ibekwe kwishishini lezempilo. Oku kufezekiswa ngokutyalomali kakhulu kuphando kunye nophuhliso, ukuqinisekisa ukuba izixhobo ezivelisiweyo zikwi-cuted yetekhnoloji yezonyango. Iqela leMfundo liyakwazi ukubonelela ngezixhobo zonyango ezinobuhlobo, ezifanelekileyo nezisebenzayo.
Iqelana le qela linenkqubo epheleleyo yetekhnoloji yokuqinisekisa owona mgangatho uphezulu wezixhobo zayo zonyango. Senza izixhobo zezonyango ezisebenzisa itekhnoloji yokusika-qatha, iqinisekisa ukuba badibana nemilinganiselo engqongqo efunwa nguShishino lweMpilo.
Ixabiso kunye nexabiso lexabiso leqela lezebubele yeyona nto iphambili ekutsaleni abathengi. Iqela lihlawula kakhulu kwi-R & D ukwenza izixhobo zezonyango ezinokufikelelwa kubathengi. Iqela le-R & D liyasebenza ngokungakhathali ukunciphisa iindleko zemveliso ngaphandle kokuncama umgangatho wemveliso. Ke ngoko, iqela elinobubele linokubonelela abathengi ngamaxabiso okhuphiswano ngaphandle kokulalanisa umgangatho wezonyango.
Iqela lezabele linoluhlu olubanzi lweemveliso ezintsha kunye neqela leengcali ezisebenza ngokungakhathali ukuqinisekisa ukuba izixhobo zazo zihlangabezana neemfuno eziguqukayo zeshishini. Iqela leMfundo lithathe le ndlela kwaye iyaqhubeka ukukhokela ishishini ngokusebenzisa izinto ezingenakumbi eziye zanceda abaguli abangenakubalwa kwihlabathi liphela.
Inethiwekhi yentengiso yehlabathi yeqela lezebubele yenye inzuzo ebabeka ngaphandle kukhuphiswano. Ngokwenza ubukho kwiimarike eziphambili kwihlabathi liphela, iinkampani zinokufikelela kubaphathi ababanzi kwaye zibeke iimveliso zabo njengemigangatho yemveliso. Olu bukhosi bokuthengisa ihlabathi luqinisekisa ukuba ezi zixhobo ziyafumaneka kwizigulana kwiindawo ezahlukeneyo zehlabathi, ngaloo ndlela ziyaqhubeka ukuba kufikeleleko lwezonyango.