Kwimarike yaseTshayina, akukho ngaphezu kwe-10pcs iinkampani ezinakhoI-FDA kunye ne-CE yoNyangokunye!
Isiqinisekiso se-CE sonyango: Ngoku amanye amazwe aseYurophu, anjengeJamani, iItali, iSpain, iNetherlands, nePoland, aza kudwelisa izixhobo zobuhle njengezixhobo zonyango.Ukuba akukho CE yezoNyango, abayi kuvunyelwa ukuba bangenise ngaphandle.Kwanokuba amasiko awakhange ahlolisise kwaye ayikhulule, urhulumente wasekhaya akayi kuvumela ukuba isetyenziswe.
I-FDA: e-USA, ukuba akukho FDA, abanakusebenzisa umatshini, umthengisi akakwazi ukuthengisa umatshini e-USA.kutheni kufuneka FDA?ULawulo lokuTya kunye neDrugs lunoxanduva lokukhusela impilo yoluntu ngokuqinisekisa ukhuseleko, ukusebenza kakuhle, kunye nokhuseleko lwamachiza abantu kunye nezilwanyana, iimveliso zebhayoloji, kunye nezixhobo zonyango;nangokuqinisekisa ukhuseleko lokubonelelwa kokutya kwesizwe, izithambiso, kunye neemveliso ezikhupha imitha.
apha oomatshini bavunywe yi-FDA kunye nesiqinisekiso se-CE soNyango
Ngenxa yokuba sinesiqinisekiso se-Medical CE, oomatshini bethu bobuhle banokuthengiswa ngempumelelo kumazwe aseYurophu, umzekelo eJamani, eItali, eSpain, eNetherlands nasePoland, akukho ngxaki kuthi.Abasasazi banokuthengisa ngokwesatifikethi soNyango lwe-CE, kunye neesaluni zobuhle okanye iklinikhi, okanye ugqirha okanye i-spa inosetyenziso olusemthethweni kwindawo yabo phantsi kwesiqinisekiso soNyango lwe-CE.
Ngenxa yokuba sine-FDA, oomatshini bethu bobuhle banokuthengiswa ngempumelelo e-United States ngaphandle kweengxaki kumasiko.Abasasazi base-USA basemthethweni kakhulu ukuthengisa oomatshini bobuhle kwimakethi yase-USA, abathengi bethu base-USA, abafana neesaluni zobuhle okanye ikliniki, okanye ugqirha okanye i-spa nazo zisemthethweni ukuzisebenzisa ekuhlaleni.
Ukusetyenziswa ngokusemthethweni kunye nentengiso kwelinye icala, kwelinye icala Medical CE isiqinisekiso kunye ne-FDA yahluke kakhulu ukuba isicelo.Yeyona 2 ingqongqo kwaye inzima ukufumana izatifikethi, ifuna i-souble ukuhlolwa kunye nokuqinisekisa umgangatho womatshini kunye nolawulo lomgangatho wefektri!
Ixesha lokuposa: Jan-18-2022