Joytech Medical yaweebwa satifikeeti ya EU Quality Management System (MDR) eyafulumizibwa Tüvsüd Süd nga April 28, 2022. Obunene bw’okuweebwa satifikeeti mulimu: Ekipima ebbugumu ekya digito ., Okulondoola puleesa ., Infrared Ear thermometer, infrared ekyenyi ebbugumu thermometer, multifunction mu bungi ekyenyi thermometer , electric breast pump, manual breast pump. Y’emu ku kkampuni ezaasooka mu China okufuna satifikeeti y’okugoberera CE wansi w’ebisaanyizo ebipya ebya MDR, era nga ye satifikeeti ya MDR esoose ey’ebipima ebbugumu eby’omu maka, ebipima ebbugumu mu matu ga infrared ne ppampu z’amabeere.
Joytech Medical ye ddagala erikola ku by’obujjanjabi nga lissa essira 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 n’ekitongole kya tekinologiya ow’omulembe mu by’okunoonyereza n’okukulaakulanya mu kibuga Hangzhou. Joytech Medical eyise ku ISO13485, MDSAP n’enkola endala ez’okuddukanya omutindo. Ebintu byaffe bifunye NMPA y’awaka, US FDA, EU CE, Canada CMDCAs, Japan PMDA n’ebirala ebiweebwa satifikeeti n’okuwandiisa, era nga bikkiriziddwa okutunda. Era tutuuse ku nkolagana ey’amaanyi ey’ekiseera ekiwanvu n’ebitongole bingi ebimanyiddwa mu ggwanga n’ebweru w’eggwanga.
EU egenda ezimba mpolampola mu katale akanene akagatta okumalawo ebiziyiza eby’obusuubuzi wakati w’amawanga agali mu mukago n’okukakasa nti abantu, obuweereza, kapito n’ebintu bitambula mu ddembe (nga ebyuma eby’obujjanjabi). Mu by’obujjanjabi, akakiiko ka Bulaaya kakoze ebiragiro bya EU bisatu okudda mu kifo ky’enkola y’okukkiriza eyasooka eya buli ggwanga eriri mu mukago, amateeka agakwata ku kutunda ebintu ng’ebyo gasobole okukwatagana.
EU MDR ejuliza etteeka eritongole 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 ekyusa ekiragiro ky’ekyuma eky’obujjanjabi ekyasooka (MDD 93/42/EEC) n’ekiragiro kya Active Medical Device Directive (AEDD) okuva nga May 26, 2020 , ekiragiro ky’ebyuma eby’obujjanjabi ebiteekebwa mu mubiri (AIMDDD 90/385/EEC).
Okugerageranya ku kiragiro ky’ebyuma eby’obujjanjabi (MDD), MDR esinga okukakali mu nsonga z’okuddukanya akabi k’ebintu, omutindo gw’ebintu n’obukuumi bw’ebintu, okwekenneenya obujjanjabi, wamu n’okwegendereza oluvannyuma lw’akatale n’okulabirira ebintu. Era kusoomoozebwa kwa maanyi eri enkola y’okuddukanya omutindo gw’omukozi n’obukuumi bw’ebintu.
Okutuuka ku buwanguzi mu satifikeeti ya MDR kiraga omutindo n’omutindo gw’ebintu bya Joytech Medical n’okusiima akatale ka EU. Joytech Medical egenda kutwala satifikeeti ya MDR CE ng’omukisa omupya ogw’okukulaakulanya okwongera okunyweza ensengeka y’akatale k’ensi yonna n’okuyamba mu mulimu gw’obujjanjabi mu nsi yonna.
