I-Joytech Medical yaklonyeliswa ngesitifiketi se-EU Quality Management System (MDR) esikhishwe i-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 asekhaya e-electronic, 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 ukne.
I-EU MDR iberies
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 nokwengamela imikhiqizo. 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.
