Thaum Lub Yim Hli 19th, Beijing Innovita Biological Technology Co., Ltd. ("INNOVITA") tau txais daim ntawv pov thawj MDSAP, uas suav nrog Tebchaws Meskas, Nyiv, Brazil, Canada, thiab Australia, uas yuav pab INNOVITA txuas ntxiv qhib kev lag luam thoob ntiaj teb.
Lub npe tag nrho ntawm MDSAP yog Medical Device Single Audit Program, uas yog ib qho kev tshuaj xyuas ib leeg rau cov khoom siv kho mob.Nws yog ib txoj haujlwm sib koom ua ke los ntawm cov tswv cuab ntawm International Medical Device Regulatory Forum (IMDRF).Lub hom phiaj yog tias lub koom haum thib peb uas tsim nyog tuaj yeem ua qhov kev tshuaj xyuas ntawm cov tuam txhab kho mob kom tau raws li QMS / GMP sib txawv ntawm cov teb chaws koom.
Qhov project tau pom zoo los ntawm tsib lub koom haum tswj hwm, US Food and Drug Administration, Canadian Health Agency, Australian Therapeutic Products Administration, Brazilian Health Agency thiab Japanese Ministry of Health, Labor thiab Welfare.Nws yog ib qho tsim nyog hais tias daim ntawv pov thawj no tuaj yeem hloov qee qhov kev tshuaj xyuas thiab kev tshuaj xyuas niaj hnub hauv cov teb chaws uas tau hais los saum toj no, thiab tau txais kev nkag mus rau kev lag luam, yog li cov ntawv pov thawj yuav tsum muaj siab.Piv txwv li, Kev Noj Qab Haus Huv Canada tau tshaj tawm tias txij Lub Ib Hlis 1, 2019, MDSAP yuav yuam hloov CMDCAS raws li Canadian kev saib xyuas cov cuab yeej siv kho mob.
Kev nrhiav tau ntawm MDSAP tsib lub teb chaws daim ntawv pov thawj tsis yog tsuas yog kev lees paub siab ntawm INNOVITA thiab nws cov khoom lag luam los ntawm Australia, Brazil, Canada, Tebchaws Meskas, thiab Nyij Pooj, tab sis kuj tseem pab INNOVITA txuas ntxiv mus nthuav tawm cov ntawv sau npe txawv teb chaws ntawm nws cov tshiab. yas kuaj reagent.Tam sim no, INNOVITA's Covid-19 kev sim tau sau npe hauv ze li 30 lub tebchaws, suav nrog Tebchaws Meskas, Brazil, Fabkis, Ltalis, Russia, Spain, Portugal, Netherlands, Hungary, Austria, Sweden, Singapore, Philippines, Malaysia, Thaib. , Argentina, Ecuador, Colombia, Peru, Chile, Mexico, thiab lwm yam.
Nws tau tshaj tawm tias INNOVITA tseem tab tom nrawm rau daim ntawv thov rau npe nrog ntau lub tebchaws thiab cov tsev kawm ntawv, nthuav dav qhov ntsuas ntawm kev sau npe txawv teb chaws ntawm Covid-19 kev sim, suav nrog kev thov rau EU CE daim ntawv pov thawj (kev kuaj tus kheej) thiab US FDA tshiab Covid-19 antigen kuaj. cov ntawv sau npe.
Kev sib kis thoob ntiaj teb txuas ntxiv mus.INNOVITA's Covid-19 cov khoom siv kuaj tau raug muag rau ntau dua 70 lub teb chaws thiab cheeb tsam, thiab lawv tau ua qhov tseeb, nrawm thiab loj-kev tshawb nrhiav rau tus kab mob SARS-CoV-2, ua lub luag haujlwm tseem ceeb hauv kev tawm tsam thoob ntiaj teb tiv thaiv Covid-19. sib kis mus.
Post lub sij hawm: Oct-18-2021