Haiyan Kangyuan Medical Isixhobo Co., Ltd. ifumene ngempumelelo imimiselo ye-EU ye-Medical Instruments (EU 2017/745, ebizwa ngokuba yi-"MDR") isatifikethi ngoFebruwari 1, 2023, inombolo yesatifikethi yi-6122159CE01, kunye nobubanzi besatifikethi bubandakanya i-Endotracheal Tubes yokusetyenziswa okukodwa, I-Catheter yokufunxa iNtsholongwane yoSetyenziso olunye, iiMasks ze-Oxygen zokusetyenziswa okukodwa, iiCannulas ze-Oxygen ze-Nasal zokusetyenziswa okukodwa, i-Guedel Airways yokusetyenziswa okukodwa, i-Laryngeal Mask Airways, iiMasks ze-Anesthesia zokusetyenziswa okukodwa, izihlungi zokuphefumla ngokuSebenzisa okukodwa, iisekethe zokuphefumla ngokuSebenzisa okukodwa.

Kuxelwe ukuba i-EU Medical Instrument Regulation MDR (EU 2017/745) yaqala ukusebenza ngoMeyi 25, 2017, ithatha indawo yeMedical Instrument Directive MDD (93/42/EEC) kunye ne-Active Implantable Medical Instrument Directive AIMDD (90/385) /EEC ), ejolise ekusekeni isikhokelo solawulo esiphucukileyo nesingqongqo ukukhusela ngcono impilo kunye nokhuseleko loluntu 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.