Ua hāʻawi ʻia ʻo Joytech Medical i ka EU Quality Management System Certificate (MDR) i hoʻopuka ʻia e TüVSüD SÜD ma ʻApelila 28, 2022. Aia ka laulā o ka hōʻoia: ana wela kikohoʻe, nānā i ke koko, ana wela pepeiao infrared, wela wela lae infrared, ana wela lae multifunction , pauma umauma uila, pamu umauma lima.ʻO ia kekahi o nā hui mua loa ma Kina e kiʻi i ka palapala hoʻokō CE ma lalo o nā koi hou o MDR, a ʻo ia ka palapala MDR mua no nā thermometer uila uila, nā thermometer pepeiao infrared a me nā pulu umauma.
ʻO Joytech Medical kahi ʻoihana lāʻau lapaʻau e kālele ana i ka R&D, ka hana ʻana a me ke kūʻai ʻana i nā mea lapaʻau no ka nānā ʻana i ke olakino a me ka hoʻokele maʻi maʻi.Mai kona hoʻokumu ʻana, ua ʻike ʻia ka hui ma ke ʻano he ʻoihana ʻenehana kiʻekiʻe a me kahi ʻoihana kikowaena R&D kiʻekiʻe ma Hangzhou.Ua hala ʻo Joytech Medical i ka ISO13485, MDSAP a me nā ʻōnaehana hoʻokele maikaʻi.Ua loaʻa i kā mākou huahana nā NMPA home, US FDA, EU CE, Canada CMDCAS, Japan PMDA a me nā palapala hōʻoia a me nā hoʻopaʻa inoa ʻē aʻe, a ua ʻae ʻia no ke kūʻai aku.A ua hōʻea mākou i ka hui hoʻolālā lōʻihi me nā ʻoihana kaulana he nui ma ka home a ma waho.
Ke kūkulu mālie nei ka EU i kahi mākeke hui nui e hoʻopau i nā pale kālepa ma waena o nā lālā lālā a hōʻoia i ka holo manuahi ʻana o nā kānaka, nā lawelawe, ke kapikala a me nā huahana (e like me nā mea lapaʻau).Ma ke kahua o nā lāʻau lapaʻau, ua hoʻomohala ke Komisina ʻEulopa i ʻekolu mau kuhikuhi EU e hoʻololi i ka ʻōnaehana accreditation kumu o kēlā me kēia lālā lālā, i hiki ke hoʻohālikelike ʻia nā lula e pili ana i ke kūʻai aku ʻana o ia mau huahana.
ʻO ka EU MDR e pili ana i ka mana o ka Medical Device Regulation (MDR) i hoʻopuka ʻia e ka EU (Medical Device Regulation (EU) 2017/745), e pili ana i nā koi o ka Paukū 123 o ka MDR.Ua hoʻokomo ʻia ka MDR i ka mana ma Mei 26, 2017 a hoʻololi hou i ka Medical Device Directive (MDD 93/42/EEC) a me ka Active Medical Device Directive (AEDD) mai Mei 26, 2020, ka Implantable Medical Devices Directive (AIMDD 90). /385/EEC).
Ke hoʻohālikelike ʻia i ka Medical Device Directive (MDD), ʻoi aku ka paʻakikī o ka MDR ma ke ʻano o ka mālama ʻana i ka pilikia o ka huahana, ka hana huahana a me nā kūlana palekana, ka loiloi lapaʻau, a me ka makaʻala ma hope o ka mākeke a me ka nānā ʻana i nā huahana.He paʻakikī nui hoʻi ia i ka ʻōnaehana hoʻokele maikaʻi o ka mea hana a me ka palekana palekana huahana.
ʻO ka holomua o ka hōʻoia MDR e hōʻike ana i ke kūlana kiʻekiʻe a me ka maikaʻi o nā huahana Joytech Medical a me ka ʻike ʻia o ka mākeke EU.E lawe ʻo Joytech Medical i ka palapala hōʻoia MDR CE ma ke ʻano he manawa hoʻomohala hou e hoʻomohala hou i ka hoʻolālā mākeke honua a hāʻawi i ka ʻoihana olakino honua.
