Ubuvuzi bwa Joytech bwahawe icyemezo cy’ubumwe bw’ibihugu by’Uburayi (MDR) cyatanzwe na TüVSüD SÜD ku ya 28 Mata 2022.Ibyemezo byatanzwe birimo: ibipimo bya sisitemu, monitor y'umuvuduko w'amaraso, infraraferi yamatwi ya termometero, infrarafuru yo mu ruhanga ya termometero, ibipimo byinshi byo mu gahanga thermometero , pompe yamabere yamashanyarazi, pompe yamabere. Ni imwe mu masosiyete ya mbere mu Bushinwa yabonye icyemezo cyo kubahiriza CE hakurikijollen, umukungugu, cyangwa dander dander. Ibidukikije b
Ubuvuzi bwa Joytech ni uruganda rukora ibikoresho byubuvuzi rwibanda kuri R&D, gukora no kugurisha ibikoresho byubuvuzi byo gukurikirana ubuzima no gucunga indwara zidakira. Kuva yashingwa, iyi sosiyete yamenyekanye nk’ikigo cy’igihugu cy’ikoranabuhanga rikomeye n’ikigo cy’ikoranabuhanga cya R&D kiri i Hangzhou. Ubuvuzi bwa Joytech bwatsinze ISO13485, MDSAP nubundi buryo bwo gucunga neza. Ibicuruzwa byacu byabonye NMPA yo mu gihugu, US FDA, EU CE, Kanada CMDCAS, Ubuyapani PMDA nibindi byemezo no kwiyandikisha, kandi byemewe kwamamaza. Kandi twageze ku bufatanye burambye n’inganda nyinshi zizwi mu gihugu ndetse no hanze yarwo.
Umuryang
Umuryango w’ubumwe bw’ibihugu by’Uburayi bivuga amabwiriza agenga ibikoresho by’ubuvuzi (MDR) yatanzwe n’ubumwe bw’ibihugu by’Uburayi (Amabwiriza y’ubuvuzi (EU) 2017/745), ashingiye ku bisabwa mu ngingo ya 123 ya MDR. MDR yatangiye gukurikizwa ku ya 26 Gicurasi 2017 maze isimbuza ku mugaragaro Amabwiriza yahoze y’ibikoresho by’ubuvuzi (MDD 93/42 / EEC) n’amabwiriza agenga ibikoresho by’ubuvuzi (AEDD) guhera ku ya 26 Gicurasi 2020, Amabwiriza y’ibikoresho by’ubuvuzi (AIMDD 90/385 / EEC).
Ugereranije n’ubuyobozi bw’ubuvuzi (MDD), MDR irakaze cyane mu bijyanye no gucunga ibicuruzwa, imikorere y’ibicuruzwa n’ibipimo by’umutekano, isuzuma ry’amavuriro, ndetse no kuba maso nyuma y’isoko no kugenzura ibicuruzwa. Nibibazo
Ibyagezweho mu cyemezo cya MDR byerekana ubuziranenge n'ubwiza bw'ibicuruzwa bya Joytech Medical no kumenyekanisha isoko ry’Uburayi. Ubuvuzi bwa Joytech buzafata icyemezo cya MDR CE nk'amahirwe mashya yo kwiteza imbere kugirango turusheho kunoza imiterere y’isoko ry’isi no kugira uruhare mu nganda z’ubuvuzi ku isi.
