Ukuhlelwa okuchanekileyo kwemveliso yakho yezonyango sisisiseko sokungena kwimarike, Ukwazi isixhobo sakho sonyango luhlelo kubaluleke kakhulu kuba:
-Ukuhlelwa kwemveliso kuya kugqiba into ekufuneka uyenzile ngaphambi kokuba uthengise imveliso yakho ngokusemthethweni.
-Ukuhlelwa kuya kukunceda umisele iimfuno ngexesha lesigaba sophuhliso lwemveliso, ngokukodwa ukuyila ulawulo. kunye nendlela yokungena kwimarike yakho.
-Ukuhlelwa yinxalenye ebalulekileyo ekuqinisekiseni ukuba uza kutyala malini ukungena kwisixhobo sakho ukuthengisa ngokusemthethweni kwaye unike ingcamango enzima yokuba kuya kuthatha ixesha elingakanani.
Ngenxa yoku, ndiza kukunika isikhokelo esincinci sokuqonda ngcono ukuba wenze ntoni kwaye wenze njani.
Lo mxholo ulandelayo ayisosikhokelo esipheleleyo sokungeniswa kwemithetho, kodwa kufuneka ikunike isikhokelo esisisiseko kunye nomkhombandlela wokuba ungahlelwa njani.
Apha siza kudwelisa "iimarike eziphambili ezi-3" njengalapha ngezantsi:
1.US Food & Drug Administration, Centre for Devices & Radiological Health (FDA CDRH); I-US FDA ihlela izixhobo zonyango zibe yinye yeeklasi ezintathu - iClass I, II, okanye III - ngokusekelwe kwiingozi zabo kunye nolawulo oluyimfuneko ukubonelela isiqinisekiso esifanelekileyo sokhuseleko kunye nokusebenza kakuhle.umzekelo i-thermometer yedijithali kunye ne-infrared thermometer zihlelwa kwiklasi II.
I-2.European Commission, ngokwe-Journal esemthethweni ye-European Union Regulation (EU) MDR 2017/745 Isihlomelo VIII, ngokusekwe kwixesha lokusetyenziswa, isixhobo esihlaselayo / esingahlaseliyo, esisebenzayo okanye esingasebenziyo, izixhobo ziseklasini I, iklasi IIa, iClass IIb kunye neklasi III.Umzekelo idijithali yezinga eliphezulu lokujonga uxinzelelo lwegazi kunye nesimbo sesihlahla yiKlasi IIa.
I-3.Ulawulo lweSizwe lweeMveliso zezoNyango lwaseTshayina, ngokweMimiselo yolawulo kunye noLawulo lwezixhobo zonyango (NO. 739 yeBhunga likarhulumente), ngokusekelwe kumngcipheko wezixhobo zonyango, zihlelwa ngamanqanaba e-3, iklasi I, iklasi II kunye iklasi III.kwakhona i-China i-NMPA ikhuphe incwadi yoluhlu lwesixhobo soNyango kwaye ihlaziywa kumaxesha ngamaxesha.Umzekelo i-stethoscope yiklasi I, i-thermometer kunye ne-blood monitor monitor ziklasi II.
Ngenkqubo yokuhlela eneenkcukacha kunye nendlela yokuhlela yamanye amazwe, kufuneka sithobele ummiselo kunye nezikhokelo ezinxulumeneyo.
Ixesha lokuposa: Feb-13-2023