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 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-Article 123 ye-MDR. i-MDR yaqala ukusebenza ngoMeyi 26, 2017 futhi ingena esikhundleni sangaphambili se-Medical Device Directive (MDD 93/42/EEC) kanye ne-Active Medical Device Directive (AEDD) kusukela ngo-May 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, ukuhl
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.
