Joytech Medical yaweebwa satifikeeti ya EU Quality Management System Certificate (MDR) eyaweebwa TüVSüD SÜD nga April 28, 2022. Obunene bw’okuweebwa satifikeeti mulimu: ekipima ebbugumu mu ngeri ya digito, omulondozi wa puleesa, infrared ear thermometer, infrared forehead thermometer, ekipima ebbugumu mu kyenyi ekikola emirimu mingi , ppampu y’amabeere ey’amasannyalaze, ppampu y’amabeere ey’omu ngalo.Y’emu ku kkampuni ezaasooka mu China okufuna satifikeeti y’okugoberera CE wansi w’ebisaanyizo by’amateeka amapya aga MDR, era ye satifikeeti ya MDR esoose ku bipima ebbugumu eby’amasannyalaze eby’omunda, ebipima ebbugumu mu matu aga infrared ne ppampu z’amabeere.
Joytech Medical kkampuni ekola ku byuma eby’obujjanjabi ng’essira eriteeka ku R&D, okufulumya n’okutunda ebyuma eby’obujjanjabi okulondoola ebyobulamu n’okuddukanya endwadde ezitawona.Okuva lwe yatandikibwawo, kkampuni eno ebadde emanyiddwa ng’ekitongole kya tekinologiya ow’omulembe mu ggwanga lyonna n’ekitongole kya tekinologiya ow’awaggulu ekya R&D center mu Hangzhou.Joytech Medical eyise mu nkola za ISO13485, MDSAP n’endala ez’okuddukanya omutindo.Ebintu byaffe bifunye satifikeeti n’okuwandiisibwa mu ggwanga NMPA, US FDA, EU CE, Canada CMDCAS, Japan PMDA n’endala, era nga bikkiriziddwa okutunda.Era tutuuse ku nkolagana ey’obukodyo ey’ekiseera ekiwanvu n’ebitongole bingi ebimanyiddwa awaka n’ebweru w’eggwanga.
EU egenda ezimba mpolampola mu katale akanene akagatta okumalawo ebiziyiza eby’obusuubuzi wakati w’amawanga agali mu mukago n’okulaba ng’abantu, empeereza, kapito n’ebintu (nga ebyuma eby’obujjanjabi) bitambula mu ddembe.Mu by’ebyuma eby’obujjanjabi, akakiiko ka Bulaaya kakoze ebiragiro bisatu ebya EU okukyusa enkola eyasooka ey’okukkiriza buli ggwanga eriri mu mukago, olwo amateeka agakwata ku kutunda ebintu ng’ebyo gasobole okukwatagana.
EU MDR kitegeeza etteeka ekitongole erya Medical Device Regulation (MDR) eryafulumizibwa EU (Medical Device Regulation (EU) 2017/745), nga lyesigamiziddwa ku byetaago ebiri mu nnyingo 123 eya MDR.MDR yatandika okukola nga May 26, 2017 era mu butongole edda mu kifo ky’eyali ekiragiro ky’ebyuma eby’obujjanjabi (MDD 93/42/EEC) n’ekiragiro ky’ebyuma eby’obujjanjabi ebikola (AEDD) okuva nga May 26, 2020 , ekiragiro ky’ebyuma eby’obujjanjabi ebiteekebwa mu mubiri (AIMDD 90 /385/EEC).
Bw’ogeraageranya n’ekiragiro ky’ebyuma eby’obujjanjabi (MDD), MDR ekakalu nnyo mu nsonga z’okuddukanya akabi k’ebintu, enkola y’ebintu n’omutindo gw’obukuumi, okwekenneenya mu malwaliro, wamu n’okwegendereza n’okulondoola ebintu oluvannyuma lw’akatale.Era kusoomoozebwa kwa maanyi eri enkola y’omukozi ey’okuddukanya omutindo n’obulungi bw’obukuumi bw’ebintu.
Okutuuka ku buwanguzi bw’okuweebwa satifikeeti ya MDR kulaga omutindo n’omutindo gw’ebintu bya Joytech Medical n’okumanyibwa kw’akatale ka EU.Joytech Medical egenda kutwala satifikeeti ya MDR CE ng’omukisa omupya ogw’enkulaakulana okwongera okuzimba ensengeka y’akatale k’ensi yonna n’okuyamba mu mulimu gw’obusawo mu nsi yonna.
