Wɔde EU Quality Management System Certificate (MDR) a Tüvsüd Süd de mae no maa Joytech Medical wɔ April 28, 2022. Nea ɛka adansedi krataa no ho ne: Digitals thermometer ., Mogya a wɔde hwɛ nneɛma so ., Infrared aso thermometer, infrared forehead thermometer, multifunction forehead thermometer , anyinam ahoɔden nufu pɔmpɛ, manual nufu pɔmpɛ. Ɛyɛ nnwumakuw a edi kan wɔ China no mu biako sɛ wobenya CE mmara sodi ho adansedi krataa wɔ mmara foforo MDR ahwehwɛde ahorow no ase, na ɛyɛ MDR adansedi krataa a edi kan ma ofie ɛlɛtrɔnik thermometers, infrared aso thermometers ne nufu pɔmpɛ.
JoyTech Medical yɛ aduruyɛ mfiri adwuma a ɛtwe adwene si R&D, aduruyɛ mfiri a wɔyɛ ne ne tɔn so ma akwahosan sohwɛ ne yareɛ a ɛnni sabea sohwɛ. Efi bere a wɔde sii hɔ no, wɔagye adwumakuw no atom sɛ ɛyɛ ɔman adwuma a wɔde mfiridwuma ho nimdeɛ a ɛkorɔn ayɛ ne adwuma a wɔde mfiridwuma ho nimdeɛ a ɛkorɔn di dwuma wɔ R&D Center wɔ Hangzhou. JoyTech Medical atwa ISO13485, MDSAP ne nhyehyɛe afoforo a ɛfa nneɛma pa ho. Yɛn nneɛma no anya ɔman no mu NMPA, US FDA, EU CE, Canada CMDCAS, Japan PMDA ne adansedi ne dinkyerɛw afoforo, na wɔapene so sɛ wɔmfa nni gua. Na yɛne nnwuma a agye din pii a ɛwɔ fie ne amannɔne no ayɛ biako bere tenten.
EU de nkakrankakra rekyekye gua kɛse a ɛyɛ biako de ayi aguadi mu akwanside ahorow afi Aman a wɔka ho no ntam na wɔahwɛ ahu sɛ nnipa, nnwuma, sika kɛse ne nneɛma a wɔyɛ (te sɛ nnuruyɛ mfiri) no bɛkɔ so kwa. Wɔ nnuruyɛ mu mfiri ho no, European Commission no ayɛ EU akwankyerɛ abiɛsa a wɔde besi Aman a wɔka ho no mu biara mfiase nhyehyɛe no ananmu, sɛnea ɛbɛyɛ a wobetumi ama mmara a ɛfa nneɛma a ɛtete saa a wɔtɔn ho no ayɛ biako.
EU MDR no kyerɛ Official Medical Device Regulation (MDR) a EU de ama (Aduruyɛ Mfiri Mmara (EU) 2017/745), a egyina nea MDR no Ahyɛde 123 hwehwɛ 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) sii ananmu wɔ aban kwan so firi May 26, 2020 , Implantable Medical Devices Directive (AIMDD 90/385/EEC).
Sɛ wɔde toto Medical Device Directive (MDD) ho a, MDR no yɛ katee kɛse wɔ nneɛma a wɔde yɛ adwuma no ho asiane ho nhyehyɛe, nneɛma a wɔyɛ ne ahobammɔ gyinapɛn ahorow, ayaresabea nhwehwɛmu, ne gua akyi ani a wɔma ɛda hɔ ne nneɛma a wɔhwɛ so no ho. Ɛyɛ asɛnnennen kɛse nso ma nea ɔyɛe no nhyehyɛe a ɛma nneɛma yɛ papa ne nneɛma a wɔyɛ no ahobammɔ ho mfaso.
MDR adansedie a wɔanya no yie no kyerɛ sɛ Joytech Medical nneɛma a ɛkorɔn ne ne su ne EU gua a wɔgye tom no yɛ papa. JoyTech Medical bɛfa MDR CE adansedie no sɛ nkɔsoɔ hokwan foforɔ a ɛbɛma wiase nyinaa gua nhyehyɛeɛ no mu ayɛ den kɛseɛ na aboa wiase nyinaa aduruyɛ adwuma.
