I te 19 o Akuhata, ka whiwhi a Beijing Innovita Biological Technology Co., Ltd. (“INNOVITA”) i te tiwhikete MDSAP, kei roto ko te United States, Japan, Brazil, Canada, me Ahitereiria, ka awhina i a INNOVITA ki te whakatuwhera ake i te maakete o te ao.
Ko te ingoa katoa o te MDSAP ko te Papatono Arotake Takitahi Pūrere Hauora, he kaupapa arotake kotahi mo nga taputapu rongoa.He kaupapa i timata tahihia e nga mema o te International Medical Device Regulatory Forum (IMDRF).Ko te whainga kia taea e tetahi tari kaute-tuatoru te whakahaere i te arotakenga o nga kaihanga taputapu rongoa hei whakatutuki i nga momo whakaritenga QMS/GMP o nga whenua whai waahi.
Kua whakaaetia te kaupapa e nga tari whakahaere e rima, te US Food and Drug Administration, Canadian Health Agency, Australian Therapeutic Products Administration, Brazilian Health Agency me te Japanese Ministry of Health, Labor and Welfare.He mea tika kia whakahuahia ka taea e tenei tiwhikete te whakakapi i etahi o nga arotakenga me nga tirotirohanga i nga whenua kua whakahuahia ake nei, me te whai waahi ki te maakete, na reira he nui nga whakaritenga tiwhikete.Hei tauira, kua panuitia e Health Canada mai i te Hanuere 1, 2019, ka whakakapia e MDSAP te CMDCAS hei kaupapa arotake urunga taputapu rongoa a Kanata.
Ko te rironga o te MDSAP e rima-whenua te tohu punaha ehara i te mea ko te tino whakanui o INNOVITA me ana hua e Ahitereiria, Brazil, Kanata, Amerika me Hapani, engari ka awhina ano hoki a INNOVITA ki te whakawhānui tonu i te tauine rehitatanga ki tawahi o ana mea hou. nga reagents whakamatautau karauna.I tenei wa, kua rehitahia nga whakamatautau Covid-19 a INNOVITA ki te tata ki te 30 whenua, tae atu ki te United States, Brazil, France, Italy, Russia, Spain, Portugal, Netherlands, Hungary, Austria, Sweden, Singapore, Philippines, Malaysia, Thailand. , Argentina, Ecuador, Colombia, Peru, Chile, Mexico, etc.
E kii ana kei te tere tonu a INNOVITA i te tono mo te rehitatanga me etahi atu whenua me nga umanga, e whakanui ana i te tauine o te rehitatanga ki tawahi mo nga whakamatautau Covid-19, tae atu ki te tono mo te tiwhikete EU CE (whakamatautau-whaiaro) me te US FDA hou Covid-19 whakamatautau antigen. rehitatanga kete.
Kei te horapa tonu te mate uruta ki te ao.Ko nga kete whakamatautau Covid-19 a INNOVITA kua hokona ki neke atu i te 70 nga whenua me nga rohe, a kua whakahaerea e ratou he tirotiro tika, tere, nui hoki mo te huaketo SARS-CoV-2, he whai waahi nui ki te whawhai o te ao ki a Covid-19 mate urutā.
Wā tuku: Oketopa-18-2021