Ua loaʻa iā INNOVITA ka palapala hōʻoia MDSAP, e wehe hou i ka mākeke honua

Ma ka lā 19 o ʻAukake, ua loaʻa iā Beijing Innovita Biological Technology Co., Ltd. ("INNOVITA") ka palapala hōʻoia MDSAP, ʻo ia hoʻi ʻo ʻAmelika Hui Pū ʻIa, Iapana, Brazil, Kanada, a me Australia, nāna e kōkua iā INNOVITA e wehe hou i ka mākeke honua.

ʻO ka inoa piha o MDSAP ʻo ia ka Medical Device Single Audit Program, ʻo ia kahi papahana loiloi hoʻokahi no nā mea lapaʻau.He papahana ia i hoʻomaka pū ʻia e nā lālā o ka International Medical Device Regulatory Forum (IMDRF).ʻO ka pahuhopu e hiki i kahi keʻena loiloi ʻaoʻao ʻekolu ke hana i ka loiloi o nā mea hana lāʻau lapaʻau e hoʻokō i nā koi QMS/GMP like ʻole o nā ʻāina i komo.

Ua ʻae ʻia ka papahana e ʻelima mau keʻena hoʻoponopono, ka US Food and Drug Administration, Canadian Health Agency, Australian Therapeutic Products Administration, Brazilian Health Agency a me ka Japanese Ministry of Health, Labor and Welfare.He mea kūpono ke ʻōlelo ʻia hiki i kēia palapala hōʻoia ke hoʻololi i kekahi o nā loiloi a me nā nānā maʻamau i nā ʻāina i ʻōlelo ʻia aʻe, a loaʻa i ka mākeke, no laila ua kiʻekiʻe nā koi hōʻoia.No ka laʻana, ua hoʻolaha ʻo Health Canada mai Ianuali 1, 2019, e koi ʻia ʻo MDSAP e hoʻololi i ka CMDCAS ma ke ʻano he papahana loiloi ʻana i ka lāʻau lapaʻau Kanada.

ʻO ka loaʻa ʻana o ka MDSAP ʻelima ʻāina ʻōnaehana hōʻoia ʻaʻole wale ka ʻike kiʻekiʻe o INNOVITA a me kāna mau huahana e Australia, Brazil, Kanada, ʻAmelika Hui Pū ʻIa, a me Iapana, akā kōkua pū kekahi iā INNOVITA e hoʻomau i ka hoʻonui ʻana i ka nui o ka hoʻopaʻa inoa o waho o kāna mea hou. leialii hoao reagents.I kēia manawa, ua hoʻopaʻa inoa ʻia nā hoʻokolohua Covid-19 o INNOVITA ma kahi o 30 mau ʻāina, me ʻAmelika Hui Pū ʻIa, Pasila, Palani, Italia, Lūkia, Sepania, Pokukala, Netherlands, Hungary, Austria, Sweden, Singapore, Philippines, Malaysia, Thailand. , Argentina, Ecuador, Colombia, Peru, Chile, Mexico, etc.

Ua hōʻike ʻia ʻo INNOVITA ke wikiwiki nei i ka noi no ka hoʻopaʻa inoa ʻana me nā ʻāina a me nā ʻoihana hou aʻe, e hoʻonui ana i ka nui o ka hoʻopaʻa inoa ʻana ma waho o nā hoʻokolohua Covid-19, me ka noi ʻana no ka EU CE hōʻoia (hoʻāʻo ponoʻī) a me ka US FDA hou Covid-19 antigen hōʻike. kakau kit.
Ke hoʻomau nei ka maʻi ahulau honua.Ua kūʻai ʻia aku nā pahu hoʻāʻo Covid-19 a INNOVITA i ʻoi aku ma mua o 70 mau ʻāina a me nā ʻāina, a ua hana lākou i nā noiʻi pololei, wikiwiki a nui hoʻi no ka maʻi maʻi SARS-CoV-2, e pāʻani ana i kahi kuleana nui i ka hakakā honua me Covid-19 mai ahulau.