: Wona EU ƒe Nyonyome Dzikpɔkpɔ ƒe Ðoɖo (MDR) si Tüvsüd Süd na le April 28, 2022. Ðaseɖigbalẽa ƒe akpa aɖewoe nye Digitál dzoxɔxɔdzidzenu ., Ʋu ƒe sisi ƒe mɔ̃ ., Infrared to thermometer, infrared forehead thermometer, multifunction fondhead thermometer , elektrik nopɔmpi, kple asi no pɔmpi. Enye dɔwɔƒe gbãtɔ siwo le China la dometɔ ɖeka be woaxɔ CE ƒe sedziwɔwɔ ƒe ɖaseɖigbalẽ le Sedede yeye si nye MDR ƒe nudidiwo te, eye wònye MDR ƒe ɖaseɖigbalẽ gbãtɔ na aƒeme elektrɔnik dzoxɔxɔdzidzenuwo, tomemɔ̃ si me dzoxɔxɔ le kple no me pɔmpiwo.
JoyTech Medical nye atikewɔnuwo ƒe dɔwɔƒe si léa ŋku ɖe atikewɔnuwo wɔwɔ kple wo dzadzra ŋu hena lãmesẽnyawo dzi kpɔkpɔ kple dɔléle siwo nɔa anyi didi dzi kpɔkpɔ. Tso esime woɖo dɔwɔƒea la, woda asi ɖe edzi be enye dukɔa ƒe mɔ̃ɖaŋudɔwɔƒe deŋgɔ eye wònye mɔ̃ɖaŋununya deŋgɔ ƒe R&D dɔwɔƒe si le Hangzhou. JoyTech Medical to ISO13485, MDSAP kple nyonyome dzikpɔkpɔ ƒe ɖoɖo bubuwo me. Míaƒe nuawo xɔ dukɔa me NMPA, United States FDA, EU CE, Canada CMDCAS, Japan PMDA kple ɖaseɖigbalẽ bubuwo kple ŋkɔ ŋɔŋlɔ, eye woda asi ɖe wo dzi hena asitsatsa. Eye míeɖo nuwɔwɔ aduadu ɣeyiɣi didi aɖe kple dɔwɔƒe xɔŋkɔ geɖe le aƒeme kple duta.
EU le tutum vivivi ɖe asi gã si wɔ ɖeka me be woaɖe asitsatsa ƒe mɔxenuwo ɖa le Dukɔ siwo le Habɔbɔa me dome eye woakpɔ egbɔ be amewo, dɔwɔnawo, ga kple nusiwo wowɔ (abe atikewɔnuwo ene) ƒe sisi faa. Le atikewɔnuwo gome la, Europa Dɔwɔha la to EU ƒe mɔfiame etɔ̃ vɛ be woatsɔ axɔ ɖe Dukɔ ɖesiaɖe si le eme ƒe mɔɖeɖedɔa wɔwɔ ƒe ɖoɖo gbãtɔ teƒe, ale be woate ŋu awɔ ɖoɖo siwo ku ɖe atike mawo ƒe asitsatsa ŋu.
EU MDR fia Atikewɔnuwo Ŋuti Se (MDR) si EU (Medical Device Regulation (EU) 2017/745 na) si dziɖuɖua na, si wotu ɖe MDR ƒe Se 123 lia ƒe nudidiwo dzi. MDR dze dɔwɔwɔ gɔme le May 26, 2017 dzi eye wòxɔ ɖe atikewɔnuwo ŋuti mɔfiame si nɔ anyi tsã (MDD 93/42/EEC) kple Atikewɔnuwo Ŋuti Mɔfiame si le Active Device Directive (AEDD) dzi le se nu tso May 26, 2020 , si nye Atikewɔnuwo ƒe Mɔfiame si Wotsɔna Ða Nu (AIMDD 90/385/EEC).
Ne wotsɔe sɔ kple Atikewɔnuwo Ŋuti Mɔfiame (MDD) la, MDR la sesẽ wu le adzɔnuwo ƒe afɔkudzikpɔkpɔ, adzɔnuwo ƒe dɔwɔwɔ kple dedienɔnɔ ƒe dzidzenuwo, atikewɔƒewo ƒe numekuku, kpakple adzɔnuwo ƒe ŋudzɔnɔnɔ kple wo dzi kpɔkpɔ megbe. Enye kuxi gã aɖe hã na adzɔnuwɔƒea ƒe nyonyome dzikpɔkpɔ ƒe ɖoɖo kple adzɔnuwo ƒe dedienɔnɔ ƒe dɔwɔwɔ nyuie.
MDR ƒe ɖaseɖigbalẽ xɔxɔ dzidzedzetɔe ɖea JoyTech Medical ƒe adzɔnuwo ƒe dzidzenu kɔkɔ kple nyonyome kple EU ƒe asi ƒe dzesidede fiana. JoyTech Medical atsɔ MDR CE ƒe ɖaseɖigbalẽa abe ŋgɔyiyi ƒe mɔnukpɔkpɔ yeye ene be wòana xexeame katã ƒe asitsatsa ƒe ɖoɖo nade to ɖe edzi eye wòawɔ akpa aɖe le xexeame katã ƒe atikewɔwɔ dɔwɔƒewo me.
