INNOVITA yapeza chiphaso cha MDSAP, chomwe chidzatsegulenso msika wapadziko lonse lapansi

Pa Ogasiti 19, Beijing Innovita Biological Technology Co., Ltd. ("INNOVITA") adalandira chiphaso cha MDSAP, chomwe chimaphatikizapo United States, Japan, Brazil, Canada, ndi Australia, zomwe zingathandize INNOVITA kutseguliranso msika wapadziko lonse lapansi.

Dzina lonse la MDSAP ndi Medical Device Single Audit Program, yomwe ndi pulogalamu imodzi yowunikira zida zachipatala.Ndi pulojekiti yomwe inayambitsidwa pamodzi ndi mamembala a International Medical Device Regulatory Forum (IMDRF).Cholinga chake ndi chakuti bungwe lovomerezeka la gulu lachitatu lizitha kufufuza opanga zida zamankhwala kuti akwaniritse zofunikira zosiyanasiyana za QMS/GMP za mayiko omwe akutenga nawo gawo.

Ntchitoyi yavomerezedwa ndi mabungwe asanu olamulira, US Food and Drug Administration, Canadian Health Agency, Australian Therapeutic Products Administration, Brazilian Health Agency ndi Ministry of Health, Labor and Welfare ku Japan.Ndikoyenera kutchula kuti chiphasochi chikhoza kulowa m'malo mwa kafukufuku wina ndi zoyendera zachizolowezi m'mayiko omwe tawatchula pamwambapa, ndikupeza mwayi wamsika, kotero kuti zofunikira za certification ndizokwera kwambiri.Mwachitsanzo, Health Canada yalengeza kuti kuyambira pa Januware 1, 2019, MDSAP ilowa m'malo mwa CMDCAS ngati pulogalamu yowunikira zida zachipatala zaku Canada.

Kupeza chiphaso cha MDSAP cha mayiko asanu sikungodziwika kokha kwa INNOVITA ndi zinthu zake ndi Australia, Brazil, Canada, United States, ndi Japan, komanso kumathandizira INNOVITA kupitiliza kukulitsa kulembetsa kumayiko akunja kwatsopano. ma reagents oyesa korona.Pakadali pano, mayeso a INNOVITA a Covid-19 adalembetsedwa m'maiko pafupifupi 30, kuphatikiza United States, Brazil, France, Italy, Russia, Spain, Portugal, Netherlands, Hungary, Austria, Sweden, Singapore, Philippines, Malaysia, Thailand. , Argentina, Ecuador, Colombia, Peru, Chile, Mexico, etc.

Akuti INNOVITA ikufulumizitsabe ntchito yolembetsa ndi mayiko ndi mabungwe ambiri, ndikukulitsa kuchuluka kwa mayeso a Covid-19 kunja kwa nyanja, kuphatikiza kupempha chiphaso cha EU CE (kudziyesa) ndi US FDA Covid-19 antigen test. kulembetsa zida.
Mliri wapadziko lonse lapansi ukupitirirabe kufalikira.Zida zoyesera za INNOVITA za Covid-19 zagulitsidwa kumayiko ndi zigawo zopitilira 70, ndipo achita kafukufuku wolondola, wachangu komanso wamkulu wa kachilombo ka SARS-CoV-2, kutenga gawo lofunikira pankhondo yapadziko lonse lapansi yolimbana ndi Covid-19. mliri.