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Izikhombisi-ndlela ezintathu zokuthola umcimbi omubi wedivayisi yezokwelapha

Isizindalwazi, igama lomkhiqizo kanye negama lomkhiqizi yizikhombisi-ndlela ezintathu eziyinhloko zokuqapha izenzakalo ezimbi zedivayisi yezokwelapha.

Ukubuyiswa kwezehlakalo ezingezinhle zensiza yezokwelapha kungenziwa kuqondiswe kusizindalwazi, futhi imininingwane egciniwe ehlukene inezici zayo.Isibonelo, isaziso semininingwane yezehlakalo ezingezinhle zedivayisi yezokwelapha yase-China yazisa njalo izehlakalo ezingezinhle zohlobo oluthile lomkhiqizo, kuyilapho izehlakalo ezimbi zedivayisi yezokwelapha ezisohlwini lwesaziso sedivayisi yezokwelapha zivela ikakhulukazi e-United States, United Kingdom, Australia nase-Canada Medical device. isexwayiso noma idatha yokukhumbula yasekhaya neyesifunda akuyona idatha yasekhaya ebikiwe;I-MAUDE database yase-United States iyisizindalwazi esigcwele, inqobo nje uma izehlakalo ezimbi zemishini yezokwelapha ezibikwe ngokwemithetho ye-FDA yase-United States zizofakwa kusizindalwazi;Izehlakalo ezimbi zedivayisi yezokwelapha / ukukhumbula / imininingwane egciniwe ehlobene nesexwayiso yamazwe nezifunda ezifana ne-United Kingdom, Canada, Australia kanye neJalimane izobuyekezwa njalo.Ukubuyisela izenzakalo ezimbi zedivayisi yezokwelapha ekuqondeni kwedathabheyisi, ingahlolwa ngokusho kwamagama angukhiye, futhi ingabuye itholakale ngokunembile ngokukhawulela isikhathi noma indawo yegama elingukhiye.

Ukuze wenze ukubuyisa isehlakalo esibi esisetshenziswa yimishini yezokwelapha ngendlela yegama lomkhiqizo, ungafaka igama lomkhiqizo wensiza yezokwelapha elindelwe ekhasini lokubuyisa lesizindalwazi ukuze ulandwe, futhi ngokuvamile awudingi ukufaka igama lomkhiqizo eliqonde kakhulu.

Lapho usesha ngokwegama lebhizinisi ledivaysi yezokwelapha, uma ibhizinisi liyibhizinisi elixhaswa ngemali yangaphandle, kuyadingeka ukuthi unake ukumelwa okuhlukile kwegama lebhizinisi, njengecala, isifinyezo, njll.

Ukuhlaziywa kokubuyiswa kwezenzakalo ezimbi ezimweni ezithile

Okuqukethwe umbiko wocwaningo lokuqapha izehlakalo ezimbi ngesisetshenziswa sezokwelapha kungase kuhlanganise kodwa kungagcini nje ngokubukeza kafushane inhloso yokuqapha kanye nohlelo lokuqapha lwesigameko esibi sedivayisi yezokwelapha;ukuqapha imithombo yedatha;isikhathi sokubuyiswa kwesigameko esibi;inani lezehlakalo ezimbi;umthombo wemibiko;izimbangela zezenzakalo ezimbi;imiphumela yezenzakalo ezimbi;ingxenye yezehlakalo ezimbi ezihlukahlukene;izinyathelo ezithathelwe izehlakalo ezimbi;futhi;Idatha yokuqapha kanye nenqubo yokuqapha inganikeza ugqozi lokubuyekezwa kobuchwepheshe, ukugadwa ngemuva kokumakethwa kwemikhiqizo, noma ukuphathwa kobungozi kwamabhizinisi okukhiqiza.

Uma kubhekwa inani elikhulu ledatha, izingcezu zolwazi ezingama-219 zitholwe ngokukhawulela “ikhodi yomkhiqizo” kuze kube uJuni 2019. Ngemva kokususa izingcezu eziyi-19 zolwazi lomcimbi ongewona omubi, izingcezu ezingama-200 ezisele zafakwa ekuhlaziyeni.Imininingwane egciniwe ikhishwa ngayinye ngayinye, kusetshenziswa isofthiwe ye-Microsoft Excel eqoqwe idatha emthonjeni wombiko, ulwazi oluhlobene nensiza yezokwelapha (okuhlanganisa igama lomkhiqizi, igama lomkhiqizo, uhlobo lwensiza yezokwelapha, izinkinga zensiza yezokwelapha) , isikhathi sokuvela kwezehlakalo ezimbi, isikhathi lapho i-FDA ithola khona izehlakalo ezimbi, uhlobo lwezehlakalo ezimbi, izimbangela zezenzakalo ezimbi, bese ihlaziya indawo yezenzakalo ezimbi Izimbangela eziyinhloko zezenzakalo ezimbi zafingqwa, futhi izinyathelo zokuthuthukisa zahlanganiswa. kubekwe phambili ezicini zokusebenza, ukwakheka kokufakelwa kanye nobuhlengikazi bangemva kokuhlinzwa.Inqubo yokuhlaziya engenhla nokuqukethwe kungasetshenziswa njengereferensi yokuhlaziywa kwezehlakalo ezimbi zedivayisi yezokwelapha efanayo.

Ukuhlaziywa kwezehlakalo ezimbi ukuze kuthuthukiswe izinga lokulawula ubungozi

Isifinyezo nokuhlaziywa kwezehlakalo ezimbi zedivayisi yezokwelapha kunokubaluleka okuthile okuyisethenjwa seminyango elawula izisetshenziswa zezokwelapha, amabhizinisi okukhiqiza nokusebenza kanye nabasebenzisi ukuze benze ukulawula ubungozi.Emnyangweni olawulayo, ukwakhiwa nokubuyekezwa kwemithetho yemishini yezokwelapha, imithetho kanye nemibhalo evamile kungenziwa kuhlanganiswe nemiphumela yokuhlaziya yezenzakalo ezimbi, ukuze kwenziwe ukulawula ubungozi nokuphathwa kwemishini yezokwelapha kube nemithetho neziqondiso okufanele zilandelwe. .Qinisa ukugadwa kokuthunyelwe kokuthengisa kwemishini yezokwelapha, qoqa futhi ufingqe izehlakalo ezimbi, isexwayiso kanye nolwazi lokukhumbula lwemishini yezokwelapha njalo, futhi ukhulule isimemezelo ngesikhathi.Ngesikhathi esifanayo, qinisa ukugadwa kwabakhiqizi bemishini yezokwelapha, misa inqubo yabo yokukhiqiza, futhi unciphise ngempumelelo amathuba okuba nezenzakalo ezimbi ezivela emthonjeni.Ngaphezu kwalokho, kufanele siqhubeke nokuthuthukisa ucwaningo lwesayensi ngokugadwa kwemishini yezokwelapha futhi sakhe uhlelo lokuhlola olusekelwe ekulawuleni ubungozi obunembile.

Izikhungo zezokwelapha kufanele ziqinise ukuqeqeshwa nokuphatha, ukuze odokotela bakwazi ukuhlangabezana nezidingo ezijwayelekile zokusebenza namakhono okusebenza kwemishini, futhi banciphise amathuba okuba nezenzakalo ezimbi.Ukuqhubeka nokuqinisa inhlanganisela yezokwelapha nobunjiniyela, nokunxusa odokotela ukuthi baxhumane nonjiniyela bokuklama idivayisi yezokwelapha ngezinkinga ezitholakala ekusetshenzisweni komtholampilo kwemishini yezokwelapha, ukuze odokotela bakwazi ukuqonda kabanzi ngemishini yezokwelapha esetshenziswayo, futhi basize. onjiniyela bemishini yezokwelapha ukuze badizayine kangcono noma bathuthukise imishini yezokwelapha.Ukwengeza, isiqondiso sokuvuselela emtholampilo kufanele siqiniswe ukuze sikhumbuze iziguli ngamaphuzu abalulekile ukuvimbela ukwehluleka ngaphambi kwesikhathi kokufakelwa ngenxa yemisebenzi yangaphambi kwesikhathi noma ukusebenza okungalungile.Ngesikhathi esifanayo, odokotela kufanele bathuthukise ukuqwashisa kwabo ngezenzakalo ezimbi zedivayisi yezokwelapha, bagweme ubungozi bokusetshenziswa kwedivayisi yezokwelapha, futhi baqoqe ngesikhathi futhi babike izehlakalo ezimbi zedivayisi yezokwelapha.