Ngomhla ziyi-19 ku-Agasti, i-Beijing Innovita Biological Technology Co., Ltd. (“INNOVITA”) yathola isitifiketi se-MDSAP, esihlanganisa i-United States, Japan, Brazil, Canada, ne-Australia, okuzosiza i-INNOVITA iqhubeke nokuvula imakethe yamazwe ngamazwe.
Igama eligcwele le-MDSAP i-Medical Device Single Audit Programme, okuwuhlelo lokucwaninga olulodwa lwemishini yezokwelapha.Kuwuhlelo oluqalwe ngokuhlanganyela amalungu e-International Medical Device Regulatory Forum (IMDRF).Inhloso ukuthi i-ejensi yokuhlola yenkampani yangaphandle efanelekayo ingakwazi ukwenza ucwaningo lwabakhiqizi bemishini yezokwelapha ukuze ihlangabezane nezimfuneko ezihlukene ze-QMS/GMP zamazwe abambe iqhaza.
Le phrojekthi yamukelwe ama-ejensi alawulayo amahlanu, i-US Food and Drug Administration, i-Canadian Health Agency, i-Australian Therapeutic Products Administration, i-Brazilian Health Agency kanye noMnyango Wezempilo, Wezabasebenzi Nenhlalakahle YaseJapane.Kuhle ukusho ukuthi lesi sitifiketi singangena esikhundleni sokunye ukuhlola nokuhlola okuvamile emazweni ashiwo ngenhla, futhi sithole ukufinyelela emakethe, ngakho izidingo zesitifiketi ziphakeme uma kuqhathaniswa.Isibonelo, i-Health Canada imemezele ukuthi kusukela ngomhlaka-1 Januwari 2019, i-MDSAP izongena esikhundleni se-CMDCAS ngempoqo njengohlelo lokubuyekeza ukufinyelela kwedivayisi yezokwelapha yase-Canada.
Ukutholwa kwesitifiketi se-MDSAP sohlelo lwamazwe amahlanu akukhona nje kuphela ukuqashelwa okuphezulu kwe-INNOVITA nemikhiqizo yayo yi-Australia, Brazil, Canada, United States, kanye ne-Japan, kodwa futhi kusiza i-INNOVITA ukuthi iqhubeke nokwandisa isikali sokubhaliswa phesheya kwezilwandle ama-reagents okuhlola umqhele.Njengamanje, ukuhlolwa kwe-INNOVITA's Covid-19 sekubhaliswe emazweni acishe abe ngu-30, okuhlanganisa i-United States, Brazil, France, Italy, Russia, Spain, Portugal, Netherlands, Hungary, Austria, Sweden, Singapore, Philippines, Malaysia, Thailand. , Argentina, Ecuador, Colombia, Peru, Chile, Mexico, njll.
Kubikwa ukuthi i-INNOVITA isasheshisa isicelo sokubhaliswa kwamanye amazwe nezikhungo, yandisa izinga lokubhaliswa phesheya kwezilwandle izivivinyo ze-Covid-19, okuhlanganisa ukufaka isicelo sesitifiketi se-EU CE (ukuzihlola) kanye ne-US FDA entsha yokuhlolwa kwe-antigen ye-Covid-19. ukubhaliswa kwekhithi.
Umqedazwe wembulunga yonke uyaqhubeka nokusabalala.Izinsiza zokuhlola ze-INNOVITA ze-Covid-19 zidayiselwe emazweni nasezifundeni ezingaphezu kuka-70, futhi benze uphenyo olunembile, olusheshayo nolukhulu lwegciwane le-SARS-CoV-2, badlala indima ebalulekile empini yomhlaba wonke yokulwa ne-Covid-19. umqedazwe.
Isikhathi sokuthumela: Oct-18-2021