Joytech Medical EU Quality Management System Certificate (MDR) a TüVSüD SÜD de maeɛ wɔ April 28, 2022. Adansedie no kɛseɛ bi ne: Wɔmaa dijitaal ɔhyew kyerɛwtohɔ, mogya mmoroso ho nhwehwɛmu, infrared aso thermometer, infrared moma so thermometer, multifunction moma so thermometer , anyinam ahoɔden nufu pɔmpɛ, nsaano nufu pɔmpɛ.Ɛyɛ nnwumakuw a wodii kan nyaa CE sodi adansedi krataa wɔ mmara foforo MDR ahwehwɛde ahorow ase no mu biako, na ɛyɛ MDR adansedi krataa a edi kan ma afie mu ɛlɛtrɔnik thermometers, infrared aso thermometers ne nufu pɔmpɛ.
Joytech Medical yɛ aduruyɛ mfiri adwumakuo a ɛde n’adwene si R&D, aduruyɛ mfiri a wɔyɛ ne ne tɔn a wɔde hwɛ akwahosan so ne nyarewa a enni sabea ano aduru so.Efi bere a wɔde sii hɔ no, wɔagye adwumakuw no atom sɛ ɔman no mu mfiridwuma a ɛkorɔn ne mfiridwuma a ɛkorɔn a wɔde yɛ nhwehwɛmu ne nkɔso adwumayɛbea wɔ Hangzhou.Joytech Medical atwam ISO13485, MDSAP ne nhyehyɛe afoforo a wɔde hwɛ nneɛma pa so.Yɛn nneɛma anya fie NMPA, US FDA, EU CE, Canada CMDCAS, Japan PMDA ne adansedi afoforo ne dinkyerɛw, na wɔapene so sɛ wɔmfa ntɔn.Na yɛne nnwuma ahorow pii a agye din wɔ fie ne amannɔne adu bere tenten a wɔde bɛyɛ adwuma wɔ ɔkwan a wɔfa so yɛ adwuma mu.
EU de nkakrankakra rekyekye ayɛ gua kɛse a wɔaka abom de ayi aguadi mu akwanside ahorow a ɛda aman a wɔka ho no ntam no afi hɔ na wɔahwɛ ahu sɛ nnipa, nnwuma, kapital ne nneɛma (te sɛ nnuruyɛ mfiri) bɛkɔ baabiara a wontua hwee.Wɔ nnuruyɛ mfiri ho no, Europa Bagua no ayɛ EU akwankyerɛ abiɛsa a wɔde besi aman a wɔka ho no mu biara mfitiase nhyehyɛe a wɔde gye tom no ananmu, sɛnea ɛbɛyɛ a wobetumi ayɛ mmara a ɛfa nneɛma a ɛtete saa a wɔtɔn ho no ahyia.
EU MDR no kyerɛ Aduruyɛ Mfiri ho Mmara (MDR) a ɛyɛ aban de a EU de ama (Aduruyɛ Mfiri Mmara (EU) 2017/745), a egyina MDR no Ahyɛdeɛ 123 no ahwehwɛdeɛ so.MDR no hyɛɛ aseɛ yɛɛ adwuma wɔ May 26, 2017 na ɛde kan Aduruyɛ Mfiri Akwankyerɛ (MDD 93/42/EEC) ne Active Medical Device Directive (AEDD) ananmu wɔ aban kwan so firi May 26, 2020 , Implantable Medical Devices Directive (AIMDD 90 /385/EEC) na ɛwɔ hɔ.
Sɛ wɔde toto Medical Device Directive (MDD) ho a, MDR no yɛ katee wɔ asiane a ɛfa nneɛma a wɔde yɛ adwuma ho, nneɛma no adwumayɛ ne ahobammɔ gyinapɛn, ayaresabea nhwehwɛmu, ne ani a wɔhwɛ wɔ gua akyi ne nneɛma a wɔhwɛ so.Ɛsan nso yɛ asɛnnennen kɛse ma nea ɔyɛ no nhyehyɛe a wɔde hwɛ nneɛma pa so ne sɛnea nneɛma no ahobammɔ yɛ yiye no.
MDR adansedie a ɛdi mu no kyerɛ Joytech Medical nneɛma a ɛkorɔn ne ne su ne EU gua a wɔgye tom.Joytech Medical bɛfa MDR CE adansedie no sɛ nkɔsoɔ hokwan foforɔ a ɛbɛma wiase nyinaa gua nhyehyɛeɛ no akɔ akyiri na aboa wiase nyinaa aduruyɛ adwuma.
