Musi waNyamavhuvhu 19, Beijing Innovita Biological Technology Co., Ltd. ("INNOVITA") yakawana certification ye MDSAP, iyo inosanganisira United States, Japan, Brazil, Canada, neAustralia, izvo zvichabatsira INNOVITA kuwedzera kuvhura musika wepasi rose.
Zita rakazara reMDSAP iMedical Device Single Audit Program, inova chirongwa chekuongorora chimwe chete chemidziyo yekurapa.Icho chirongwa chakatangwa pamwe chete nenhengo dzeInternational Medical Device Regulatory Forum (IMDRF).Chinangwa ndechekuti mubatanidzwa wechitatu-bato rekuongorora unokwanisa kuita ongororo yevagadziri vemidziyo yekurapa kuti vasangane nezvinodiwa zvakasiyana zveQMS/GMP zvenyika dziri kutora chikamu.
Chirongwa ichi chakabvumidzwa nemasangano mashanu anodzora, US Food and Drug Administration, Canadian Health Agency, Australian Therapeutic Products Administration, Brazilian Health Agency uye Japan Ministry of Health, Labor and Welfare.Zvakakodzera kuti titaure kuti chitupa ichi chinogona kutsiva mamwe ekuongorora uye ongororo yenguva dzose munyika dzataurwa pamusoro, uye kuwana mukana wemusika, saka izvo zvinodikanwa zvetifiketi zvakatonyanya.Semuenzaniso, Health Canada yakazivisa kuti kubva muna Ndira 1, 2019, MDSAP ichamanikidzira kutsiva CMDCAS sechirongwa chekuCanada chekuongorora mudziyo wekurapa.
Kutorwa kweMDSAP yenyika shanu certification hakusi iko kucherechedzwa kwepamusoro kweINNOVITA uye zvigadzirwa zvayo neAustralia, Brazil, Canada, United States, neJapan, asiwo kunobatsira INNOVITA kuti ienderere mberi nekuwedzera chiyero chekunyoresa mhiri kwemakungwa kweiyo itsva. korona yekuongorora reagents.Parizvino, INNOVITA's Covid-19 bvunzo dzakanyoreswa munyika dzinosvika makumi matatu, kusanganisira United States, Brazil, France, Italy, Russia, Spain, Portugal, Netherlands, Hungary, Austria, Sweden, Singapore, Philippines, Malaysia, Thailand. , Argentina, Ecuador, Colombia, Peru, Chile, Mexico, etc.
Zvinonzi INNOVITA ichiri kumhanyisa chikumbiro chekunyoreswa nedzimwe nyika nemasangano, ichiwedzera huwandu hwekunyoreswa kwemhiri kwemakungwa kweCovid-19 bvunzo, kusanganisira kunyorera EU CE certification (self-test) uye US FDA itsva Covid-19 antigen bvunzo. kit registration.
Denda repasi rose riri kuramba richipararira.INNOVITA's Covid-19 test kits yakatengeswa kunyika dzinopfuura makumi manomwe nematunhu, uye vakaita ongororo, nekukurumidza uye kwakakura kwehutachiona hweSARS-CoV-2, vachiita basa rakakosha muhondo yepasi rose yekurwisa Covid-70. chirwere chapararira munzvimbo.
Nguva yekutumira: Oct-18-2021