Iimveliso

Iindaba ezimnandi, iJoytech Medical yawongwa ngeSatifikethi se-EU MDR!

Joytech Medicalyanikezelwa ngeSatifikethi seNkqubo yoLawulo loMgangatho we-EU (MDR) ekhutshwe yi-TüVSüD SÜD ngo-Epreli 28, 2022. Umda wesatifikethi ubandakanya:ithemometha yedijithali, esweni uxinzelelo lwegazi, ithemometha ye-infrared indlebe, ithemometha ye-infrared ebunzi, i-multifunction ye-thermometer ebunzi, impompo yebele yombane, impompo yebele yezandla.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 lobugcisa 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, iKhomishini yaseYurophu iye yaphuhlisa izikhokelo ezintathu ze-EU zokutshintsha inkqubo yokuvunywa yangaphambili yelizwe ngalinye elilungu, ukuze 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 iqalise 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.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 ubume bemarike yehlabathi kunye negalelo kushishino lwezonyango lwehlabathi.

 

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