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 imiyoboro ya Endotracheal ikoreshwa rimwe, Sterile Suction Catheter yo gukoresha rimwe, Masike ya Oxygene ikoreshwa rimwe, Nasal Oxygen Laryngeal Mask Airways, Anesthesia Mask yo Gukoresha Rimwe, Guhumeka Akayunguruzo ko Gukoresha Rimwe, Guhumeka Inzira yo Gukoresha Rimwe.

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 MDD (93/42 / EEC) n’ubuvuzi bw’ibikoresho by’ubuvuzi AIMDD (90/385 / EEC), agamije gushyiraho uburyo bunoze kandi bunoze bwo kurinda ubuzima bw’umutekano n’umutekano. 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.