Iindaba

Iibhedi zonyango zinokubizwa ngokuba ziibhedi zonyango, iibhedi zonyango, iibhedi zabahlengikazi, njl njl. Ziibhedi ezisetyenziswa zizigulane xa zilele esibhedlele. Zisetyenziswa ikakhulu kwizibhedlele ezikhulu, amaziko ezempilo asezilokishini, amaziko eenkonzo zempilo yoluntu, njl.

I-US FDA ifuna ukuba xa ukutya kunye neemveliso zonyango zingena kwimarike yase-US, kufuneka zibhaliswe kwiwebhusayithi esemthethweni ye-FDA ngaphambi kokuba zingene kwimarike yase-US.

Iibhedi zesibhedlele zihlelwa njengezixhobo zonyango ze-Class I kwi-FDA. ULawulo lokuTya kunye neziyobisi lwase-US luchaza izixhobo zeKlasi I njenge "ezingajoliswanga ukuba zisetyenziselwe ukugcina ubomi okanye ukugcina ubomi, okanye zibalulekile ekuthinteleni ukwenzakala kwimpilo yabantu, kwaye zinokuthi zingabonakali "Izixhobo ezibeka umngcipheko ongekho ngqiqweni wokugula okanye ukwenzakala.” Ezi zixhobo ziluhlu oluqhelekileyo lwezixhobo ezilawulwa yi-FDA, zibalelwa kwi-47% yezixhobo ezivunyiweyo kwimarike. Izixhobo zeKlasi I zinonxibelelwano oluncinci lwesigulane kwaye zinempembelelo encinci kwimpilo yesigulana jikelele. Ngokuqhelekileyo, izixhobo zeKlasi I azidibanisi nezitho zangaphakathi zesigulane, inkqubo ye-nervous central, okanye inkqubo ye-cardiovascular system. Ezi zixhobo ziphantsi kweemfuneko zolawulo ezincinci.

Isiqinisekiso se-FDA sezixhobo zonyango sibandakanya: ukubhaliswa komvelisi kunye ne-FDA, ukubhaliswa kwemveliso ye-FDA, ukubhaliswa koluhlu lwemveliso (ukubhaliswa kwefomu ye-510), uluhlu lwemveliso (uphononongo lwe-PMA), ukuleyibheli kunye nokuguqulwa kobugcisa, ukukhutshwa kwezithethe, ukubhaliswa, kunye nengxelo yangaphambi kwentengiso yezonyango kunye izixhobo zokhathalelo lwempilo, Ezi mathiriyeli zilandelayo kufuneka zingeniswe:

(1) Iikopi ezintlanu zeemveliso ezipakishwe ngokupheleleyo

(2) Umzobo wesakhiwo sesixhobo kunye nenkcazo yesicatshulwa

(3) Ukusebenza kunye nomgaqo wokusebenza kwesixhobo

(4) Umboniso wokhuseleko okanye imathiriyeli yovavanyo yesixhobo

(5) Intshayelelo kwinkqubo yokuvelisa

(6) Isishwankathelo sezilingo zeklinikhi

(7) Imiyalelo yemveliso. Ukuba ifowuni ineempawu ze-radioactive okanye ikhupha imathiriyeli ye-radioactive, kufuneka ichazwe ngokweenkcukacha.

Umjikelo weProjekthi

Ixesha elisuka kuvavanyo lwe-FDA ukuya ekuvunyweni kokugqibela lide ngokubanzi kwaye lilawulwa yi-FDA; ngokuqhelekileyo yonke inkqubo eqhelekileyo umjikelo malunga 12 iinyanga

Inkqubo yesicelo se-510K yeebhedi zasesibhedlele imi ngolu hlobo lulandelayo:

1. I-FDA 510(K) iimfuno zokuthobela uxwebhu lobugcisa

2. Uhlalutyo olusemgangathweni olusebenzayo kwi-US FDA 510k yokubhaliswa

3. Ukuqinisekiswa kokufumaneka kwamaxwebhu akhoyo

4. Ukuqokelelwa kunye nokuthelekisa iimveliso ezibhalisiweyo kwimarike

5. Lungisa ulwazi lwemveliso ngokuhambelana neemfuno ze-US FDA 510k

6. Lungiselela amaxwebhu obhaliso ayi-510k ngokwemigangatho

7. Yenza uhlaziyo olusekelwe kwiziphumo zokuphononongwa kwamaxwebhu obhaliso

8. Gqibezela ukubhaliswa kwenkampani kunye nokubhaliswa koluhlu lwemveliso

I-taishaninc inesatifikethi sokuthumela ngaphandle kwihlabathi jikelele
Ineesubsidiaries ezi-5 ngokupheleleyo
Ukugubungela izixhobo zokwakha, imichiza, kunye nemizi-mveliso yezixhobo zonyango
Siyifektri enesatifikethi sokuthumela ngaphandle elizweni jikelele, enexabiso lemveliso yonyaka eyi-5,000,000 yeedola kunye nokuthunyelwa ngaphandle kumazwe angaphezu kwe-160 kwihlabathi liphela. Singowona mzi mveliso mkhulu wepaki wemizi-mveliso odityanisiweyo kwindawo yendawo. Ukuba kuyimfuneko, nceda uqhagamshelane nathi kwangethuba kwaye uthumele iinkcukacha zemveliso.