Haiyan Kangyuan Medical Isixhobo I-Co., Ltd. ifumene ngempumelelo imimiselo ye-EU ye-Medical Instruments (i-EU 2017/745, ebizwa ngokuba yi-"MDR") isatifikethi ngoFebruwari 1, 2023, inombolo yesatifikethi yi-6122159CE01, kunye nobubanzi besatifikethi sibandakanya i-Endotracheal Tubes yokusetyenziswa okukodwa, i-Sterile Suction Mask Use for Sixy I-Oxygen Cannulas yokusetyenziswa okukodwa, i-Guedel Airways yokusetyenziswa okukodwa, i-Laryngeal Mask Airways, iiMasks ze-Anesthesia zokusetyenziswa okukodwa, izihlungi zokuphefumla zokusetyenziswa okukodwa, iisekethe zokuphefumla ngokuSebenzisa okukodwa.

Kuxelwe ukuba i-EU Medical Instrument Regulation MDR (EU 2017/745) yaqala ukusebenza ngoMeyi 25, 2017, ithatha indawo ye-Medical Instrument Directive MDD (93/42/EEC) kunye ne-Active Implantable Medical Instrument Directive AIMDD (90/385/EEC) ejolise kwisakhelo sezempilo esiphucukileyo kunye nokhuseleko oluphuculweyo lokumisela inkqubo yezempilo ephucukileyo. uluntu kunye nezigulane. Phakathi kwabo, i-MDR ibeke phambili iimfuno ezingqongqo kubenzi bezixhobo zonyango ngokubhekiselele kulawulo lomngcipheko wemveliso, ukusebenza kwemveliso kunye nemigangatho yokhuseleko, ukuhlolwa kweklinikhi, kunye nesilumkiso se-post-market kunye nokulawula. Xa kuthelekiswa nomyalelo we-MDD, i-MDR elawulayo inolawulo olunamandla, isatifikethi esinzima ngakumbi, kwaye inika ingqwalasela engakumbi kukhuseleko kunye nokusebenza kakuhle kweemveliso.

I-Kangyuan Medical ifumene ngempumelelo isatifikethi se-MDR ngeli xesha, ebonisa ngokupheleleyo ukuba iimveliso ze-Kangyuan zifikelele ekuqaphelisweni kwe-EU kunye neemarike zamazwe ngamazwe ngokubhekiselele kulawulo lwemveliso, ukuqinisekiswa komgangatho kunye nokulawulwa kwengozi.

Kwi-Kangyuan Medical, eye yabandakanyeka ngokunzulu kwimarike yaseYurophu iminyaka engaphezu kweshumi, ukufunyanwa kwesatifikethi se-MDR yinto ebalulekileyo. , ILatin America kunye nezinye iimarike zinike inkxaso eqinile.