Joytech Medical an ba shi takardar shedar Tsarin Gudanar da Ingancin EU (MDR) wanda TüVSüD SÜD ya bayar a ranar 28 ga Afrilu, 2022. Iyalin takaddun ya haɗa da: dijital thermometer, duban hawan jini, infrared ma'aunin zafi da sanyio, infrared ma'aunin zafi da sanyio, ma'aunin zafi da sanyio na goshi, Multifunction goshi ma'aunin zafi da sanyio , famfo nono na lantarki, famfon nono na hannu. Yana daya daga cikin kamfanoni na farko a kasar Sin don samun takardar shaidar yarda da CE a karkashin sabuwar ka'ida ta MDR, kuma ita ce takardar shaidar MDR ta farko ta na'urar auna zafin jiki na cikin gida, thermometers na infrared da kuma famfun nono.
Joytech Medical sana'a ce ta na'urar likitanci da ke mai da hankali kan R&D, samarwa da siyar da na'urorin likitanci don kula da lafiya da kula da cututtuka na yau da kullun. Tun lokacin da aka kafa shi, an san kamfanin a matsayin babban kamfani na fasahar kere-kere na kasa da kuma babbar cibiyar kasuwanci ta R&D a Hangzhou. Joytech Medical ya wuce ISO13485, MDSAP da sauran tsarin gudanarwa masu inganci. Kayayyakinmu sun sami NMPA na gida, FDA ta Amurka, EU CE, Kanada CMDASs, Japan PMDA da sauran takaddun shaida da rajista, kuma an yarda da su don talla. Kuma mun kai dogon lokaci dabarun hadin gwiwa tare da yawa shahararrun masana'antu a gida da waje.
Sannu a hankali EU tana gina babbar kasuwa mai haɗin kai don kawar da shingen kasuwanci tsakanin ƙasashe membobi da tabbatar da zirga-zirgar mutane, ayyuka, jari da kayayyaki kyauta (kamar na'urorin likitanci). A fagen na'urorin likitanci, Hukumar Tarayyar Turai ta samar da umarnin EU guda uku don maye gurbin ainihin tsarin amincewa da kowace ƙasa memba, ta yadda za a iya daidaita ƙa'idodin da suka shafi tallan irin waɗannan samfuran.
EU MDR tana nufin ƙa'idar Na'urar Likita (MDR) ta EU (Dokar Na'urar Lafiya (EU) 2017/745), dangane da buƙatun Mataki na 123 na MDR. MDR ya fara aiki ne a ranar 26 ga Mayu, 2017 kuma a hukumance ya maye gurbin tsohon Dokar Na'urar Kiwon Lafiya (MDD 93/42/EEC) da Dokar Na'urar Kula da Lafiya (AEDD) tun daga ranar 26 ga Mayu, 2020, Dokar Na'urorin Likitan da za a iya dasa (AIMDD 90/385/EEC).
Idan aka kwatanta da Umarnin Na'urar Likita (MDD), MDR ya fi tsauri dangane da sarrafa haɗarin samfur, aikin samfur da ƙa'idodin aminci, kimantawa na asibiti, gami da faɗakarwa bayan kasuwa da sa ido kan samfuran. Hakanan babban ƙalubale ne ga tsarin sarrafa ingancin masana'anta da ingancin amincin samfur.
Nasarar da aka samu na takaddun shaida na MDR yana nuna babban matsayi da ingancin samfuran Joytech Medical da kuma amincewar kasuwar EU. Joytech Medical zai ɗauki takaddun shaida na MDR CE a matsayin sabon damar haɓakawa don ƙara zurfafa tsarin kasuwancin duniya da ba da gudummawa ga masana'antar likitancin duniya.
