Ukuthengisa ukutya, izithambiso, iziyobisi, kunye nezinye iimveliso kwi-Amazon US ayifuni kuphela ukuqwalaselwa kwemveliso yokupakishwa, ukuthutha, amaxabiso, kunye nokuthengisa, kodwa kufuna imvume evela kwi-US Food and Drug Administration (FDA). Iimveliso ezibhaliswe kwi-FDA zinokungena kwimarike yase-US ukuze zithengiswe ukuphepha umngcipheko wokukhutshwa.
Ukuthotyelwa kunye nokuqinisekiswa komgangatho ngundoqo ekuthunyelweni ngaphandle, kwaye ukufumana isatifikethi se-FDA "yipasipoti" yokungena kwimarike yase-US. Ke yintoni isiqinisekiso se-FDA? Zeziphi iintlobo zeemveliso ekufuneka zibhaliswe kwi-FDA?
I-FDA liqumrhu elilawulayo likarhulumente wase-US onoxanduva lokuqinisekisa ukhuseleko, ukusebenza kakuhle, kunye nokuthotyelwa kokutya, amachiza, izixhobo zonyango, kunye nezinye iimveliso ezinxulumene noko. Eli nqaku liza kwazisa ukubaluleka kwesatifikethi se-FDA, ukuhlelwa kwesatifikethi, inkqubo yokuqinisekiswa, kunye nezinto ezifunekayo zokufaka isicelo sokuqinisekiswa. Ngokufumana isatifikethi se-FDA, iinkampani zinokudlulisela ukuzithemba kumgangatho wemveliso kunye nokhuseleko kubathengi kwaye zandise ngakumbi intengiso yazo.
Ukubaluleka kweSiqinisekiso se-FDA
Ukuqinisekiswa kwe-FDA yenye yezinto eziphambili kwiinkampani ezininzi ukuba zifezekise impumelelo kwimarike yase-US. Ukufumana isatifikethi se-FDA kuthetha ukuba imveliso ihlangabezana nemigangatho engqongqo kunye neemfuno ze-FDA, ezinomgangatho ophezulu, ukhuseleko, kunye nokuthotyelwa. Kubathengi, isatifikethi se-FDA sisiqinisekiso esibalulekileyo somgangatho wemveliso kunye nokhuseleko, ukubanceda benze izigqibo zokuthenga ezinolwazi. Kumashishini, ukufumana isatifikethi se-FDA kunokonyusa isidima sohlobo, ukonyusa intembeko yabathengi, kwaye kuncede iimveliso ziphume phambili kukhuphiswano lwentengiso.
Uvavanyo lwe-FDA
2. Ukuhlelwa kwesatifikethi se-FDA
Isatifikethi se-FDA sibandakanya iindidi ezininzi zeemveliso, ingakumbi ezibandakanya ukutya, amayeza, izixhobo zonyango, ibhayoloji, kunye neemveliso zemitha. I-FDA iphuhlise imigangatho yesatifikethi ehambelanayo kunye neenkqubo kwiindidi zeemveliso ezahlukeneyo. Ukuqinisekiswa kokutya kubandakanya ukubhaliswa kwamashishini okuvelisa ukutya, ukuvunywa kwezongezo zokutya, kunye nokuthotyelwa kweelebhile zokutya. Isiqinisekiso sechiza sibandakanya ulingo lwezonyango kunye nokuvunywa kwamachiza amatsha, isiqinisekiso sokulingana kwamachiza enziwe afana nalawo aveliswe ngabenzi, kunye nokuveliswa nokuthengiswa kwamachiza. Isiqinisekiso sesixhobo sonyango siquka ukuhlelwa kwezixhobo zonyango, 510 (k) isaziso saphambi kokuthengisa, kunye nesicelo se-PMA (esivunywe kwangaphambili). Ukuqinisekiswa kwemveliso yebhayoloji kubandakanya ukuvunywa kunye nokubhaliswa kogonyo, iimveliso zegazi, kunye neemveliso zonyango lwemfuza. Isiqinisekiso semveliso yeradiation sigubungela isiqinisekiso sokhuseleko sezixhobo zonyango, amayeza eradiopharmaceuticals, kunye neemveliso zombane.
3. Zeziphi iimveliso ezifuna isiqinisekiso se-FDA?
3.1 Uvavanyo lwe-FDA kunye nokuqinisekiswa kwezinto zokupakisha ukutya
3.2 Uvavanyo lwe-FDA kunye nokuqinisekiswa kweemveliso zeglasi ze-ceramic
3.3 Uvavanyo lwe-FDA kunye noqinisekiso lweemveliso zeplastiki zomgangatho wokutya
3.4 Ukutya: kubandakanywa ukutya okugayiweyo, ukutya okupakishiweyo, ukutya okukhenkcezisiweyo, njl
3.5 Izixhobo zoNyango: IiMaski kunye neZixhobo zoKhuselo, njl
3.6 Amayeza: Amayeza kagqirha kunye namayeza athengwayo, njl
3.7 Izongezo zokutya, izongezo zokutya, njl
3.8 Iziselo
3.9 Izixhobo ezinxulumene nokutya
3.10 Uvavanyo lwe-FDA kunye nokuqinisekiswa kweemveliso zokugquma
3.11 UVavanyo lwe-FDA ye-Plumbing Hardware kunye neSiqinisekiso
3.12 Uvavanyo lwe-FDA kunye nokuqinisekiswa kweemveliso ze-rubber resin
3.13 Izinto zokutywina uVavanyo lwe-FDA kunye neSiqinisekiso
3.14 Uvavanyo lwe-FDA kunye nesiqinisekiso sezongezo zekhemikhali
3.15 Iimveliso zeLaser Radiation
3.16 Izithambiso: izongezo zemibala, izinto zokuthambisa ulusu, nezicoci, njl.
3.17 Iimveliso zezilwanyana: izidakamizwa zezilwanyana, ukutya kwezilwanyana, njl
3.18 Iimveliso zecuba
ILebhu yoVavanyo lwe-BTF, inkampani yethu ineelabhoratri ezihambelanayo ne-electromagnetic, imimiselo yokhuseleko ILabhoratri, iLebhu yerediyo engenazingcingo, iLebhu yebhetri, iLebhu yeekhemikhali, iLabhoratri yeSAR, iLabhoratri ye-HAC, njl. I-VCCI, njl. Ukuba unovavanyo olufanelekileyo kunye neemfuno zesatifikethi, ungaqhagamshelana ngokuthe ngqo nabasebenzi bethu boVavanyo ukuze ufumane iikowuti zeendleko ezineenkcukacha kunye nolwazi lomjikelo!
Ukubhaliswa kwe-FDA yonyango
Ixesha lokuposa: Aug-14-2024
