Ka August 19th, Beijing Innovita Biological Technology Co., Ltd. ("INNOVITA") e fumane setifikeiti sa MDSAP, se kenyeletsang United States, Japane, Brazil, Canada le Australia, e tla thusa INNOVITA ho tsoela pele ho bula 'maraka oa machaba.
Lebitso le felletseng la MDSAP ke Medical Device Single Audit Program, e leng lenaneo le le leng la tlhahlobo ea lisebelisoa tsa bongaka.Ke morero o qaliloeng ka kopanelo ke litho tsa Foramo ea Taolo ea Lisebelisoa tsa Kalafo ea Machaba (IMDRF).Sepheo ke hore setsi sa tlhahlobo sa motho oa boraro se tšoanelehang se ka etsa tlhahlobo ea bahlahisi ba lisebelisoa tsa bongaka ho fihlela litlhoko tse fapaneng tsa QMS/GMP tsa linaha tse nkang karolo.
Morero o amohetsoe ke mekhatlo e mehlano ea taolo, Tsamaiso ea Lijo le Lithethefatsi ea US, Setsi sa Bophelo sa Canada, Tsamaiso ea Lihlahisoa tsa Therapeutic ea Australia, Setsi sa Bophelo sa Brazil le Lekala la Bophelo bo Botle la Japane, Mosebetsi le Boiketlo.Ho bohlokoa ho bolela hore setifikeiti sena se ka nka sebaka sa tse ling tsa lihlahlobo le litlhahlobo tse tloaelehileng linaheng tse boletsoeng ka holimo, le ho fumana phihlello ea mebaraka, kahoo litlhoko tsa setifikeiti li batla li phahame.Mohlala, Health Canada e phatlalalitse hore ho tloha ka la 1 Pherekhong 2019, MDSAP e tla nka sebaka sa CMDCAS joalo ka lenaneo la tlhahlobo ea phihlello ea lisebelisoa tsa bongaka tsa Canada.
Ho nkuoa ha setifikeiti sa MDSAP ea linaha tse hlano ha se feela kananelo e phahameng ea INNOVITA le lihlahisoa tsa eona ke Australia, Brazil, Canada, United States le Japane, empa hape e thusa INNOVITA ho tsoela pele ho atolosa sekhahla sa ngoliso ea mose ho maoatle ea eona e ncha. li-reagents tsa tlhahlobo ea moqhaka.Hajoale, liteko tsa Covid-19 tsa INNOVITA li se li ngolisitsoe linaheng tse ka bang 30, ho kenyeletsoa United States, Brazil, France, Italy, Russia, Spain, Portugal, Netherlands, Hungary, Austria, Sweden, Singapore, Philippines, Malaysia, Thailand. , Argentina, Ecuador, Colombia, Peru, Chile, Mexico, joalo-joalo.
Ho tlalehoa hore INNOVITA e ntse e potlakisa kopo ea ho ingolisa le linaha le litsi tse ngata, e holisa sekhahla sa ngoliso ea liteko tsa Covid-19 mose ho maoatle, ho kenyelletsa le ho etsa kopo ea setifikeiti sa EU CE (iteko) le tlhahlobo e ncha ea antigen ea US FDA. ngoliso ea lisebelisoa.
Seoa sa lefatše lohle se ntse se tsoela pele ho ata.Lisebelisoa tsa tlhahlobo tsa Covid-19 tsa INNOVITA li rekisitsoe linaheng le libaka tse fetang 70, 'me li entse lipatlisiso tse nepahetseng, tse potlakileng le tse kholo bakeng sa vaerase ea SARS-CoV-2, e bapala karolo ea bohlokoa ntoeng ea lefats'e khahlanong le Covid-19. sewa.
Nako ea poso: Oct-18-2021