I-Haiyan Kangyuan Medical Into yokwenza utho I-Co, Ltd ithole ngempumelelo imithetho yezinsimbi zezokwelapha ze-EU (EU 2017/745, okukhulunywa ngayo njengesitifiketi se- "MDR") ngoFebhuwari 1, 2023, inombolo yesitifiketi ingu-6122159ce01, futhi ubukhulu bokuqiniseka bufaka amashubhu e-endotracheal ngokusetshenziswa okukodwa, I-petile catherent catheter yokusebenzisa okukodwa, imaski ye-oxygen yokusetshenziswa okukodwa, ama-oxygen we-nasal oxygen wokusebenzisa okukodwa, ama-airngeal mask airways, ama-anesthesia masks wokusetshenziswa okukodwa, izihluthu zokuphefumula zokusetshenziswa okukodwa, ukuphefumula amasekethe wokusetshenziswa okukodwa.

Kubikwa ukuthi i-EU Medical Instrument Autetion MDR (EU 2017/745) yaqala ukusebenza ngoMeyi 25, 2017, ifaka esikhundleni se-Medical Instrute MDD (93/42 / EEC) kanye ne-Aimperive Offentible Medical Inutive Directive (90/385 / EEC), ihlose ukusungula uhlaka lwabantu abahlelekile nolujwayelekile bokuvikela impilo kanye nokuphepha komphakathi neziguli. Phakathi kwazo, i-MDR ibeke phambili izidingo ezinzima zabakhiqizi bezinsimbi zezokwelapha ngokuya ngokulawulwa kobungozi boMkhiqizo, ukusebenza komkhiqizo kanye namazinga okuphepha, ukuqashelwa kwemitholampilo, kanye nokuqwashisa ngemakethe ngemuva. Uma kuqhathaniswa nomyalo we-MDD, i-MDD ye-MDD inokuqondisa okuqinile, isitifiketi esinzima ngokwengeziwe, futhi ikhokha ukunakwa okwengeziwe ekuphepheni nasekusebenzeni kwemikhiqizo.

I-Kangyuan Medical ithole ngempumelelo isitifiketi se-MDR ngalesi sikhathi, esifakazela ngokuphelele ukuthi imikhiqizo yaseKangyuan ifinyelele ekuqashelweni kwe-EU nezimakethe zezwe ngokuqinisekiswa kwekhwalithi kanye nokulawulwa kwengozi.

Kwe-Kangyuan Medical, ebihileleke kakhulu emakethe yaseYurophu iminyaka engaphezu kweshumi, ukutholwa kwesitifiketi se-MDR kuyinto engqondweni. , ILatin America nezinye izimakethe zinikeze ukwesekwa okuqinile.