I-Joytech Medical yaklonyeliswa ngesitifiketi se-EU Quality Management System (MDR) esikhishwe yi-TüVSüD SÜD ngo-April 28, 2022. Ububanzi besitifiketi buhlanganisa: i-thermometer yedijithali, ukuqapha umfutho wegazi, I-infrared ear thermometer, ithemometha yasebunzini le-infrared, ithemometha yasebunzini elisebenza ngezinto eziningi , iphampu yebele kagesi, iphampu yebele yezandla.Ingenye yezinkampani zakuqala e-China ukuthola isitifiketi sokuthobela i-CE ngaphansi kwezimfuneko ze-MDR zomthetho omusha, futhi iyisitifiketi sokuqala se-MDR samathemometha kagesi asekhaya, ama-thermometer endlebe e-infrared namaphampu amabele.
IJoytech Medical yibhizinisi lemishini yezokwelapha eligxile kuR&D, ukukhiqizwa nokudayiswa kwemishini yezokwelapha yokuqapha impilo nokulawulwa kwezifo ezingamahlalakhona.Kusukela yasungulwa, inkampani iye yaqashelwa njengebhizinisi lezwe lobuchwepheshe obuphezulu kanye nebhizinisi lesikhungo se-R&D sobuchwepheshe obuphezulu e-Hangzhou.IJoytech Medical idlule i-ISO13485, MDSAP nezinye izinhlelo zokuphatha ikhwalithi.Imikhiqizo yethu ithole i-NMPA yasekhaya, i-US FDA, i-EU CE, i-Canada CMDCAS, i-Japan PMDA nezinye izitifiketi nokubhaliswa, futhi ivunyelwe ukumakethwa.Futhi sesifinyelele ukubambisana kwamasu wesikhathi eside namabhizinisi amaningi adumile ekhaya naphesheya.
I-EU kancane kancane yakha imakethe enkulu ebumbene ukuze isuse imigoqo yohwebo phakathi kwamazwe angamalungu futhi iqinisekise ukugeleza kwamahhala kwabantu, izinsizakalo, izimali ezinkulu kanye nemikhiqizo (njengemishini yezokwelapha).Emkhakheni wemishini yezokwelapha, i-European Commission ithuthukise iziqondiso ezintathu ze-EU ukuze zithathele indawo uhlelo lokuqala lokugunyaza lezwe ngalinye eliyilungu, ukuze imithethonqubo ephathelene nokumakethwa kwemikhiqizo enjalo ivumelane.
I-EU MDR ibhekisela ku-Medical Device Regulation (MDR) ekhishwe yi-EU (Medical Device Regulation (EU) 2017/745), ngokusekelwe ezimfuneko ze-Athikili 123 ye-MDR.i-MDR yaqala ukusebenza ngoMeyi 26, 2017 futhi ingena ngokusemthethweni esikhundleni se-Medical Device Directive (MDD 93/42/EEC) kanye ne-Active Medical Device Directive (AEDD) kusukela ngoMeyi 26, 2020, i-Implantable Medical Devices Directive (AIMDD 90). /385/EEC).
Uma kuqhathaniswa ne-Medical Device Directive (MDD), i-MDR iqine kakhulu ngokuphathelene nokulawulwa kwengozi yomkhiqizo, ukusebenza komkhiqizo kanye namazinga okuphepha, ukuhlolwa komtholampilo, kanye nokuqapha kwangemva kwemakethe nokuqondisa kwemikhiqizo.Kuphinde kube yinselelo enkulu ohlelweni lokuphatha ikhwalithi lomkhiqizi kanye nempumelelo yokuphepha komkhiqizo.
Ukuphumelela ngempumelelo kwesitifiketi se-MDR kukhombisa izinga eliphezulu kanye nekhwalithi yemikhiqizo ye-Joytech Medical kanye nokuqashelwa kwemakethe ye-EU.IJoytech Medical izothatha isitifiketi se-MDR CE njengethuba elisha lokuthuthuka ukuze iqhubeke nokujulisa ukwakheka kwezimakethe zomhlaba futhi ibe negalelo embonini yezokwelapha yomhlaba wonke.
