Izindaba

I-Illumaxbio ithole isaziso esivela ku-CMDE (Center For Medical Device Evaluation) ye-Sichuan Medical Prouducts Administration ngoNovemba 11, ivuma ukuthi i-Automatic Multiplex Immunoassay System ye-Illumaxbio ingabuyekezwa ngokuhambisana nenqubo yokubuyekeza ekhethekile yokuxilongwa kwe-in vitro (IVD).Kubikwa ukuthi i-Illumaxbio iyinkampani yokuqala ye-IVD esifundazweni saseSichuan ukungena kwinqubo yokubuyekezwa okukhethekile kwamadivayisi wezokwelapha ngo-2021. I-multiplex ye-multiplex ye-Immunoassay System yokuqala emhlabeni wonke eyethulwe yi-Illumaxbio, enomklamo ohlakaniphile wezidingo zomtholampilo, ephula ubuchwepheshe. ukuvinjelwa kwezingxenye eziningi eziyinhloko, futhi lonke iketango lizimele futhi liyalawuleka.

Ukufakwa ohlwini lwemishini yezokwelapha esungulwayo kazwelonke kufuna kakhulu, ngenani lokugunyazwa elingu-5.2% ngo-2021. Izimfuneko zimi kanje:
·Unelungelo lobunikazi - Umfakisicelo unelungelo lobunikazi noma ilungelo lokusebenzisa ubuchwepheshe obuyisisekelo bomkhiqizo eShayina ngokomthetho
·Ukusungula izinto ezintsha – umgomo oyinhloko wokusebenza womkhiqizo uqalwa ngumfakisicelo ekhaya, kanti ubuchwepheshe busezingeni eliphezulu emhlabeni wonke, elinokubaluleka okusobala komtholampilo.
·Umkhiqizo – Umkhiqizo usuqediwe.Inqubo yocwaningo ilawulwa ngempela, futhi idatha yocwaningo ilandeleka ngokuphelele.

Inqubo ekhethekile yokugunyazwa iyindlela esheshayo yemishini yezokwelapha;I-National Medical Products Administration izobeka kuqala ukubuyekezwa nokugunyaza ngesisekelo sokuthi amazinga awehliswa futhi izinqubo azincishiswa.Ngokwezibalo ze-National Medical Products Administration (NMPA), umkhiqizo ongena enqubweni yokugunyazwa okukhethekile uthola isitifiketi sokubhaliswa se-NMPA ezinsukwini ezingama-83 ngaphambi kweminye imikhiqizo efanayo, okufinyeza kakhulu umjikelezo wokunikeza izitifiketi futhi kwandise ukuncintisana.Lapho isitifiketi sokubhalisa sisheshe sithola, ithuba elingcono lokuthwebula isabelo semakethe.