Emva kweminyaka emibini yokulungiselela, iBeijing Lingze yezoNyango ifumene ngempumelelo i-Medical Device Marketing Authorization (MDMA) esuka kwiSaudi Arabia's Food and Drug Authority (SFDA) ngoJuni 25, 2025. Le mvume igubungela umgca wethu wemveliso opheleleyo, kubandakanywa i-catheters ye-PICC, iimpompo zokungenisa ukutya, iiseti ze-enteral feeding, iingxowa ze-TPN, kunye nokwandisa i-nasoga ye-marketing yethu.
Ugunyaziwe olawula izixhobo zonyango eSaudi Arabia nguGunyaziwe woKutya & neZiyobisi zaseSaudi (i-SFDA), enoxanduva lokulawula, ukongamela, nokuhlola ukutya, amayeza, kunye nezixhobo zonyango, kunye nokumisela imigangatho enyanzelekileyo kubo. Izixhobo zonyango zingathengiswa kuphela okanye zisetyenziswe eSaudi Arabia emva kokubhaliswa kwi-SFDA kunye nokufumana i-Medical Device Marketing Authorization (MDMA).
I-Saudi Food and Drug Authority (SFDA) ifuna abavelisi bezixhobo zonyango ukuba banyule uMmeli oGunyaziweyo (AR) ukuba enze egameni labo kwimarike. I-AR isebenza njengonxibelelwano phakathi kwabavelisi bangaphandle kunye ne-SFDA. Ukongeza, i-AR inoxanduva lokuthotyelwa kwemveliso, ukhuseleko, izibophelelo zasemva kwentengiso, kunye nokuhlaziywa kokubhaliswa kwesixhobo sonyango. Ilayisenisi ye-AR esebenzayo inyanzelekile ekuphumeni kwempahla ngexesha lokungeniswa kwemveliso.
Ngesatifikethi sethu se-SFDA ngoku sikhona, i-L&Z Medical ikulungele ngokupheleleyo ukubonelela amaziko ezempilo aseSaudi ngomgca wethu opheleleyo weemveliso zonyango. Hlala ubukele uhlaziyo olungakumbi njengoko siqhubeka nokwandisa ubukho bethu kwimarike yoMbindi Mpuma.
Ixesha lokuposa: Jun-25-2025