I-Joytech Medical yanikezelwa ngeSatifikethi seNkqubo yoLawulo loMgangatho we-EU (MDR) ekhutshwe yi-TüVSüD SÜD ngo-Aprili 28, 2022. Umda wesatifikethi uquka: ithemometha yedijithali, esweni uxinzelelo lwegazi, Ithemometha ye-infrared ear, i-infrared ye-earhead thermometer, i-multifunction ye-thermometer ebunzi , impompo yamabele yombane, impompo yesifuba ye-manual.Yenye yeenkampani zokuqala e-China ukufumana isatifikethi sokuthobela i-CE phantsi kommiselo omtsha weemfuno ze-MDR, kwaye sisiqinisekiso sokuqala se-MDR kwiithemometha zombane zasekhaya, iithemomitha ze-infrared zendlebe kunye neempompo zamabele.
IJoytech Medical lishishini lesixhobo sonyango esijolise kwi-R&D, ukuveliswa kunye nokuthengiswa kwezixhobo zonyango zokubeka iliso kwimpilo kunye nolawulo lwezifo ezingapheliyo.Ukusukela ekusekweni kwayo, inkampani iye yamkelwa njengeshishini lesizwe lobuchwepheshe obuphezulu kunye neshishini le-R&D elikumgangatho ophezulu eHangzhou.I-Joytech Medical iphumelele i-ISO13485, i-MDSAP kunye nezinye iinkqubo zokulawula umgangatho.Iimveliso zethu zifumene i-NMPA yasekhaya, i-US FDA, i-EU CE, iCanada CMDCAS, iJapan PMDA kunye nezinye iziqinisekiso kunye nokubhaliswa, kwaye zivunyiwe ukuba zithengiswe.Kwaye sifikelele kwintsebenziswano yexesha elide yeqhinga kunye namashishini amaninzi adumileyo ekhaya nakwamanye amazwe.
I-EU ngokuthe ngcembe yakha kwimarike enkulu emanyeneyo ukuphelisa imiqobo yorhwebo phakathi kwamazwe angamalungu kunye nokuqinisekisa ukuhamba ngokukhululekileyo kwabantu, iinkonzo, inkunzi kunye neemveliso (ezifana nezixhobo zonyango).Kwinkalo yezixhobo zonyango, iKomishoni yaseYurophu iye yaphuhlisa imiyalelo emithathu ye-EU ukuba ithathe indawo yenkqubo yokuqala yokuvunywa kwelungu ngalinye lelizwe, ukwenzela ukuba imimiselo ephathelele ukuthengiswa kweemveliso ezinjalo ihambelane.
I-EU MDR ibhekisela kwi-Medical Device Regulation (MDR) esemthethweni ekhutshwe yi-EU (i-Medical Device Regulation (EU) 2017/745), ngokusekelwe kwiimfuno zeSiqendu 123 se-MDR.i-MDR yaqala ukusebenza ngoMeyi 26, 2017 kwaye ithatha indawo ngokusemthethweni yangaphambili ye-Medical Device Directive (MDD 93/42/EEC) kunye ne-Active Medical Device Directive (AEDD) ukususela ngoMeyi 26, 2020, i-Implantable Medical Devices Directive (AIMDD 90). /385/EEC).
Xa kuthelekiswa ne-Medical Device Directive (MDD), i-MDR ingqongqo ngokubhekiselele kulawulo lomngcipheko wemveliso, ukusebenza kwemveliso kunye nemigangatho yokhuseleko, ukuhlolwa kweklinikhi, kunye nokuqapha emva kwemarike kunye nokulawulwa kweemveliso.Ikwangumceli mngeni omkhulu kwinkqubo yolawulo lomgangatho womenzi kunye nokusebenza ngokhuseleko kwemveliso.
Ukuphumelela okuyimpumelelo kwesiqinisekiso se-MDR kubonisa umgangatho ophezulu kunye nomgangatho weemveliso zeJoytech Medical kunye nokuqatshelwa kwemarike ye-EU.IJoytech Medical iza kuthatha isatifikethi se-MDR CE njengethuba elitsha lophuhliso lokuqhubeka nokwenza nzulu ubume bemarike yehlabathi kunye negalelo kushishino lwezonyango lwehlabathi.
