Joytech Medical yi nyikiwile Xitifikheti xa EU xa Sisiteme ya Vulawuri bya Khwalithi (MDR) lexi humesiweke hi TüVSüD SÜD hi Hukuri 28, 2022. Vukulu bya xitifikheti byi katsa: xipima xa ku hisa xa xidijitali, monitor wa nsusumeto wa ngati, infrared ear thermometer, infrared forehead thermometer, multifunction forehead thermometer , pompo ya mavele ya gezi, pompo ya mavele ya manual.I yin’wana ya tikhamphani to sungula eChina ku kuma xitifikheti xa ku landzelela CE ehansi ka swilaveko swa MDR swa nawu lowuntshwa, naswona i xitifikheti xo sungula xa MDR xa tithermometer ta elektroniki ta laha kaya, ti thermometer ta tindleve ta infrared na tipompo ta mavele.
Joytech Medical i bindzu ra switirhisiwa swa vutshunguri leri kongomisaka eka R&D, vuhumelerisi na ku xavisiwa ka switirhisiwa swa vutshunguri ku veka tihlo eka rihanyo na vulawuri bya mavabyi lama nga tshungulekiki.Ku sukela loko yi simekiwile, khamphani yi amukeriwile tanihi bindzu ra thekinoloji ya le henhla ra rixaka na bindzu ra thekinoloji ya le henhla ya senthara ya R&D eHangzhou.Joytech Medical yi pasile ISO13485, MDSAP na tisisiteme tin’wana ta vulawuri bya khwalithi.Switirhisiwa swa hina swi kumile NMPA ya laha kaya, US FDA, EU CE, Canada CMDCAS, Japan PMDA na switifikheti swin’wana na ku tsarisiwa, naswona swi pfumeleriwile ku xavisiwa.Naswona hi fikelerile ntirhisano wa maqhinga wa nkarhi wo leha na mabindzu yo tala ya ndhuma laha kaya na le matikweni mambe.
EU yi aka hakatsongotsongo eka makete lowukulu lowu hlanganeke ku herisa swihinga swa mabindzu exikarhi ka matiko ya swirho na ku tiyisisa ku khuluka loku ntshunxekeke ka vanhu, vukorhokeri, xiphemu xa mali na swikumiwa (ku fana na switirhisiwa swa vutshunguri).Eka xiyenge xa switirhisiwa swa vutshunguri, Khomixini ya Yuropa yi endle swiletelo swinharhu swa EU ku siva fambiselo ro sungula ra mpfumelelo wa tiko rin’wana na rin’wana ra xirho, leswaku milawu leyi khumbaka ku xavisiwa ka switirhisiwa swo tano yi ta fambisana.
MDR ya EU yi kombetela eka Nawumbisi wa Ximfumo wa Switirhisiwa swa Vutshunguri (MDR) lowu humesiweke hi EU (Nawumbisi wa Switirhisiwa swa Vutshunguri (EU) 2017/745), lowu simekiweke eka swilaveko swa Xiyenge xa 123 xa MDR.MDR yi sungurile ku tirha hi ti 26 ta Mawuwani 2017 naswona yi siva ximfumo xa khale ka Xiletelo xa Switirhisiwa swa Vutshunguri (MDD 93/42/EEC) na Xiletelo xa Switirhisiwa swa Vutshunguri leswi Tirhaka (AEDD) ku sukela hi ti 26 ta Mawuwani 2020 , Xiletelo xa Switirhisiwa swa Vutshunguri leswi nga Vekiwaka (AIMDD 90 /385/EEC) leyi nge).
Loko ku pimanisiwa na Xiletelo xa Switirhisiwa swa Vutshunguri (MDD), MDR yi tiyile swinene hi mayelana na vulawuri bya khombo ra swikumiwa, matirhelo ya swikumiwa na swiyimo swa vuhlayiseki, ku kamberiwa ka tliliniki, xikan’we na ku xalamuka endzhaku ka makete na vulawuri bya swikumiwa.Nakambe i ntlhontlho lowukulu eka sisiteme ya vulawuri bya khwalithi ya muendli na ku tirha kahle ka vuhlayiseki bya swikumiwa.
Ku humelela loku humelelaka ka xitifikheti xa MDR swi kombisa xiyimo xa le henhla na khwalithi ya swikumiwa swa Joytech Medical na ku xiximiwa ka makete wa EU.Joytech Medical yi ta teka xitifikheti xa MDR CE tanihi nkarhi wuntshwa wa nhluvukiso ku ya emahlweni yi dzikisa maendlelo ya makete wa misava hinkwayo na ku hoxa xandla eka indasitiri ya swa vutshunguri ya misava hinkwayo.
