INNOVITA enwetala asambodo MDSAP, nke ga-emepewanye ahịa mba ụwa

Na August 19th, Beijing Innovita Biological Technology Co., Ltd. ("INNOVITA") nwetara asambodo MDSAP, nke gụnyere United States, Japan, Brazil, Canada, na Australia, nke ga-enyere INNOVITA aka imeghe ahịa mba ụwa.

N'uju aha MDSAP bụ Medical Device Single Audit Programme, nke bụ otu mmemme nyocha maka ngwaọrụ ahụike.Ọ bụ oru ngo sitere n'aka ndị otu International Medical Device Regulatory Forum (IMDRF) malitere.Ebumnuche bụ na ụlọ ọrụ nyocha nke ndị ọzọ tozuru etozu nwere ike duzie nyocha nke ndị na-emepụta ngwaọrụ ahụike iji mezuo ụdị QMS/GMP dị iche iche nke mba ndị na-esonye.

Ụlọ ọrụ na-ahụ maka nchịkwa ise akwadoro ọrụ a, Ụlọ Ọrụ Na-ahụ Maka Nri na Ọgwụ na US, Ụlọ Ọrụ Ahụike Canada, Ụlọ Ọrụ Ọgwụ Ọgwụ Australia, Ụlọ Ọrụ Ahụike Brazil na Ụlọ Ọrụ Na-ahụ Maka Ahụ Ike, Ọrụ na ọdịmma Japan.Ọ dị mma ịkọwa na asambodo a nwere ike dochie ụfọdụ nyocha na nyocha oge na mba ndị a kpọtụrụ aha n'elu, ma nweta ohere ahịa, ya mere ihe ndị a chọrọ n'akwụkwọ ikike dị elu.Dịka ọmụmaatụ, Health Canada ekwuputala na site na Jenụarị 1, 2019, MDSAP ga-amanye dochie CMDASS dị ka mmemme nleba anya ngwaọrụ ahụike Canada.

Nnweta nke asambodo sistemụ mba ise nke MDSAP abụghị naanị nnabata dị elu nke INNOVITA na ngwaahịa ya sitere n'Australia, Brazil, Canada, United States na Japan, kamakwa na-enyere INNOVITA aka ịga n'ihu na-agbasa ọkwa ndebanye nke mba ofesi nke ọhụrụ ya. okpueze ule reagent.Ka ọ dị ugbu a, edebanyela ule Covid-19 nke INNOVITA n'ihe fọrọ nke nta ka ọ bụrụ mba 30, gụnyere United States, Brazil, France, Italy, Russia, Spain, Portugal, Netherlands, Hungary, Austria, Sweden, Singapore, Philippines, Malaysia, Thailand. , Argentina, Ecuador, Colombia, Peru, Chile, Mexico, wdg.

A na-akọ na INNOVITA ka na-eme ngwa ngwa maka ndebanye aha na mba na ụlọ ọrụ ndị ọzọ, na-agbasa ọnụ ọgụgụ nke ndebanye aha esenidụt nke ule Covid-19, gụnyere itinye akwụkwọ maka asambodo EU CE (nnwale onwe onye) na US FDA ọhụrụ Covid-19 antigen test. ndebanye aha kit.
Ọrịa na-efe efe zuru ụwa ọnụ ka na-agbasa.E rerela ngwa nnwale nke INNOVITA's Covid-19 karịa mba na mpaghara 70, ha emeela nyocha ziri ezi, ngwa ngwa na nnukwu maka nje SARS-CoV-2, na-ekere òkè dị mkpa na ọgụ zuru ụwa ọnụ megide Covid-19. ntiwapụ ọrịa.