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.
I-Joytech Medical lishishini lesixhobo sonyango eligxile kwi-R&D, ukuveliswa kunye nokuthengiswa kwezixhobo zonyango zokujonga impilo 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 edibeneyo ukuphelisa imiqobo yorhwebo phakathi kwamazwe angamalungu kunye nokuqinisekisa ukuhamba ngokukhululekileyo kwabantu, iinkonzo, inkunzi kunye neemveliso (ezifana nezixhobo zonyango). Kwinkalo yezixhobo zonyango, iKhomishini yaseYurophu iye yaphuhlisa izikhokelo ezintathu ze-EU ukuze zithathe indawo yenkqubo yokuqala yokuvunywa kwelizwe ngalinye elilungu, ukuze imimiselo ephathelele ukuthengiswa kweemveliso ezinjalo ihambelane.
I-EU MDR ibhekisela kwi-Medical Device Regulatio
Xa kuthelekiswa ne-Medical Device Directive (MDD), i-MDR ingqongqo ngakumbi ngokubhekiselele kulawulo lomngcipheko wemveliso, ukusebenza kwemveliso kunye nemigangatho yokhuseleko, ukuhlolwa kweklinikhi, kunye nokuqapha emva kwemarike kunye nokulawulwa kweemveliso. Kukwangumceli mngeni omkhulu kwinkqubo yolawulo lomgangatho womenzi kunye nokusebenza kokhuseleko lwemveliso.
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 uyilo lwemarike yehlabathi kunye negalelo kushishino lwezonyango lwehlabathi.
