Ubuvuzi bwa Joytech bwahawe icyemezo cy’ubumwe bw’ibihugu by’Uburayi (MDR) cyatanzwe na TüVSüD SÜD ku ya 28 Mata 2022. Urwego rw’impamyabumenyi rurimo: ibipimo bya sisitemu, monitor y'umuvuduko w'amaraso, infrared ugutwi thermometero, infrarafuru yo mu ruhanga ya termometero, imikorere myinshi yo mu ruhanga ya termometero , pompe yamabere yamashanyarazi, pompe yamabere.Ni imwe mu masosiyete ya mbere mu Bushinwa yabonye icyemezo cyo kubahiriza CE hakurikijwe amabwiriza mashya ya MDR asabwa, kandi ni icyemezo cya mbere cya MDR ku bipimo bya elegitoroniki yo mu rugo, ibikoresho byo mu matwi bitagira ingano na pompe.
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, 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 no mu mahanga.
Umuryango w’ubumwe bw’ibihugu by’Uburayi uragenda wubaka buhoro buhoro ku isoko rinini ryunze ubumwe kugira ngo rikureho inzitizi z’ubucuruzi hagati y’ibihugu bigize uyu muryango no kwemeza ko abantu, serivisi, imari n’ibicuruzwa byinjira (nk’ibikoresho by’ubuvuzi).Mu rwego rw’ibikoresho by’ubuvuzi, Komisiyo y’Uburayi yashyizeho amabwiriza atatu y’ubumwe bw’ibihugu by’Uburayi kugira ngo asimbuze uburyo bw’umwimerere bwo kwemerera buri gihugu cy’abanyamuryango, kugira ngo amabwiriza ajyanye no kwamamaza ibicuruzwa nk'ibyo abashe guhuzwa.
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 ari ibikoresho by’ubuvuzi (MDD 93/42 / EEC) hamwe n’amabwiriza agenga ibikoresho by’ubuvuzi (AEDD) guhera ku ya 26 Gicurasi 2020, Amabwiriza y’ibikoresho by’ubuvuzi (AIMDD 90) / 385 / EEC).
Ugereranije nubuyobozi bwibikoresho byubuvuzi (MDD), MDR irakaze cyane mubijyanye no gucunga ingaruka zibicuruzwa, imikorere y’ibicuruzwa n’ibipimo by’umutekano, isuzuma ry’amavuriro, ndetse no kuba maso nyuma y’isoko no kugenzura ibicuruzwa.Nibibazo kandi bikomeye kuri sisitemu yo gucunga neza ibicuruzwa no gukora neza ibicuruzwa.
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 kurushaho kurushaho kunoza imiterere y’isoko ry’isi no kugira uruhare mu nganda z’ubuvuzi ku isi.
