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Kunyumba » Mabulogu » Nkhani Za Kampani » Nkhani yabwino, Joytech Medical idapatsidwa Chiphaso cha EU MDR!

Nkhani yabwino, Joytech Medical idapatsidwa Chiphaso cha EU MDR!

Mawonedwe: 0     Wolemba: Mkonzi Watsamba Nthawi Yosindikiza: 2022-04-30 Poyambira: Tsamba

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Joytech Medical  adalandira Satifiketi ya EU Quality Management System (MDR) yoperekedwa ndi TüVSüD SÜD pa Epulo 28, 2022. digito thermometer, kuwunika kuthamanga kwa magazi, Infrared ear thermometer, infrared pamphumi thermometer, multifunction pamphumi thermometer , pampu yamagetsi yamagetsi, pampu yamanja yamanja.Ndi amodzi mwamakampani oyambilira ku China kuti alandire satifiketi yotsata CE pansi pa malamulo atsopano a MDR, ndipo ndi satifiketi yoyamba ya MDR yama thermometers apanyumba, ma thermometers a khutu a infrared ndi mapampu am'mawere.

 

Joytech Medical ndi bizinesi yazida zamankhwala yomwe imayang'ana kwambiri R&D, kupanga ndi kugulitsa zida zamankhwala zowunikira zaumoyo komanso kasamalidwe ka matenda osatha.Chiyambireni kukhazikitsidwa kwake, kampaniyo yakhala ikuzindikiridwa ngati bizinesi yapamwamba kwambiri komanso yaukadaulo wapamwamba wa R&D ku Hangzhou.Joytech Medical wadutsa ISO13485, MDSAP ndi machitidwe ena oyang'anira khalidwe.Zogulitsa zathu zapeza ziphaso zapakhomo za NMPA, US FDA, EU CE, Canada CMDCAS, Japan PMDA ndi ziphaso ndi zolembetsa zina, ndipo zavomerezedwa kuti zigulitsidwe.Ndipo tafika ku mgwirizano wanthawi yayitali ndi mabizinesi ambiri otchuka kunyumba ndi kunja.

 

EU pang'onopang'ono ikupanga msika waukulu wogwirizana kuti athetse zopinga zamalonda pakati pa mayiko omwe ali mamembala ndikuonetsetsa kuti anthu, ntchito, ndalama ndi katundu (monga zipangizo zamankhwala) zikuyenda mwaufulu.Pankhani ya zida zamankhwala, bungwe la European Commission lapanga malangizo atatu a EU kuti alowe m'malo mwa njira yovomerezeka yovomerezeka ya membala aliyense, kuti malamulo okhudzana ndi malonda amtunduwu agwirizane.

 

EU MDR ikunena za Medical Device Regulation (MDR) yoperekedwa ndi EU (Medical Device Regulation (EU) 2017/745), kutengera zofunikira za Article 123 ya MDR.MDR inayamba kugwira ntchito pa May 26, 2017 ndipo idzalowa m’malo mwa Medical Device Directive (MDD 93/42/EEC) komanso Active Medical Device Directive (AEDD) kuyambira pa May 26, 2020, Implantable Medical Devices Directive (AIMDD 90). /385/EEC).

 

Poyerekeza ndi Medical Device Directive (MDD), MDR imakhala yokhwimitsa zinthu kwambiri poyang'anira chiwopsezo cha zinthu, magwiridwe antchito ndi miyezo yachitetezo, kuunika kwachipatala, komanso kuyang'anira pambuyo pa msika ndi kuyang'anira zinthu.Zimakhalanso zovuta kwambiri pa kayendetsedwe ka khalidwe la wopanga ndi chitetezo cha mankhwala.

 

Kupambana kopambana kwa satifiketi ya MDR kukuwonetsa mulingo wapamwamba komanso mtundu wazinthu za Joytech Medical komanso kuzindikira kwa msika wa EU.Joytech Medical itenga chiphaso cha MDR CE ngati mwayi watsopano wopititsa patsogolo msika wapadziko lonse lapansi ndikuthandizira pamakampani azachipatala padziko lonse lapansi.

 

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