Ubuvuzi bwa Haiyan Kangyuan Igikoresho Co, Ltd. yabonye neza amabwiriza y’ibikoresho by’ubuvuzi by’ubumwe bw’ibihugu by’Uburayi (EU 2017/745, byitwa “MDR”) icyemezo cyo ku ya 1 Gashyantare 2023, nomero y’icyemezo ni 6122159CE01, kandi mu rwego rwo gutanga impamyabumenyi harimo Endotracheal Tubes yo gukoresha rimwe, Sterile Suction Catheter yo Gukoresha Rimwe, Masike ya Oxygene yo Gukoresha Rimwe, Cannula ya Nasal Oxygene yo Gukoresha Rimwe, Guedel Airways yo Gukoresha Rimwe, Mask Airways ya Laryngeal, Anesthesia Mask yo Gukoresha Rimwe, Guhumeka Akayunguruzo ko Gukoresha Rimwe, Guhumeka Umuyoboro umwe.

Biravugwa ko amabwiriza agenga ibikoresho by’ubuvuzi by’ubumwe bw’ibihugu by’Uburayi MDR (EU 2017/745) yatangiye gukurikizwa ku ya 25 Gicurasi 2017, asimbuza amabwiriza y’ubuvuzi MDD (93/42 / EEC) hamwe n’ubuyobozi bwa AIMDD (90/385) / EEC), igamije gushyiraho uburyo bugezweho kandi bukomeye bwo kugenzura ubuzima n’umutekano by’abaturage n’abarwayi. Muri byo, MDR yashyize ahagaragara ibisabwa bikomeye ku bakora ibikoresho by’ubuvuzi mu bijyanye no gucunga ingaruka z’ibicuruzwa, imikorere y’ibicuruzwa n’ibipimo by’umutekano, isuzuma ry’amavuriro, no kumenyesha no kugenzura nyuma y’isoko. Ugereranije nubuyobozi bwa MDD, MDR igenzura ifite ubugenzuzi bukomeye, ibyemezo bigoye, kandi yita cyane kumutekano no gukora neza kubicuruzwa.

Ubuvuzi bwa Kangyuan bwabonye impamyabumenyi ya MDR kuriyi nshuro, byerekana neza ko ibicuruzwa bya Kangyuan byageze ku kumenyekanisha Umuryango w’ubumwe bw’ibihugu by’Uburayi n’amasoko mpuzamahanga mu bijyanye no kugenzura umusaruro, kwizeza ubuziranenge no gucunga ingaruka.

Ku buvuzi bwa Kangyuan, bumaze imyaka irenga icumi bugira uruhare runini ku isoko ry’iburayi, kubona icyemezo cya MDR ni intambwe ikomeye. , Amerika y'Epfo n'andi masoko yatanze inkunga ikomeye.