Kupambana Kwapadziko Lonse kwa Joytech: Zitsimikizo za MDR & FDA za Mzere Wathunthu Wogulitsa

Ndi kukhwimitsa kochulukira kwa malamulo a zida zachipatala padziko lonse lapansi, makampani akunja omwe akulowa m'misika yaku Europe ndi America akuyenera kukwaniritsa osati zovuta zovomerezeka zogulira msika, komanso kuthana ndi Kuwunika Kwambiri kwa Flying (No Not Notice Inspection) ndi Post-Market Surveillance (PMS). Pali kusiyana kwakukulu pamalingaliro owongolera, njira zowunikira komanso zilango pakati pa US FDA ndi EU MDR/IVDR.

Kodi FDA (US Food and Drug Administration) ndi chiyani ?
A FDA amawongolera chitetezo ndi magwiridwe antchito a zida zamankhwala ku United States. Pazida zambiri, opanga akuyenera kupereka 510(k) kuti atsimikizire kuti malonda awo ndi otetezeka, ogwira mtima, komanso ofanana kwambiri ndi chipangizo chomwe chilipo kale.

Kodi MDR (Medical Device Regulation) ?
MDR ndi malamulo a European Union pazida zamankhwala, m'malo mwa MDD wakale (Medical Device Directive). Lili ndi zofunikira zokhwima pakuwunika kwachipatala, kuyang'anitsitsa pambuyo pa msika, ndi zolemba zamakono kuti zitsimikizire chitetezo chapamwamba cha odwala ndi kuwonekera.

Kuyenda onse a FDA ndi MDR ndizovuta-koma zovuta. Ku Joytech, tapanga njira yodalirika yolumikizirana padziko lonse lapansi kuti tithandizire mabizinesi athu kukwaniritsa miyezo yovutayi molimba mtima. Kaya mukukulira ku US kapena kulowa mu EU pansi pa MDR, katundu wathu wovomerezeka, zolemba zaukadaulo, ndi ukatswiri wamalamulo zili pano kuti zikuthandizeni.

Zomwe tingachite ​​ ​​?

Ku Joytech, takhazikitsa maziko olimba kuti tilimbikitse anzathu padziko lonse lapansi. Joytech yapanga ndondomeko yoyendera bwino komanso yoyang'ana kutsogolo yomwe imakwaniritsa zofunikira zapadziko lonse lapansi pamisika yayikulu yazachipatala.

FDA 510 (k) Chilolezo

Joytech yakhazikitsa kale kupezeka kwamphamvu pamsika waku US, ndi mizere yathu yonse yazogulitsa kale FDA idayeretsedwa ndikuperekedwa mwachangu kwa mabwenzi apadziko lonse lapansi. Kutengera maziko ovomerezekawa, timayika ndalama mosalekeza pakupanga zinthu zatsopano ndi kukonzanso malamulo kuti tikwaniritse zosowa zachipatala zomwe zikukula komanso zofuna za mapulojekiti okhudzana ndi anzathu.

Mu 2025, tidakulitsa mbiri yathu ya FDA ndi ziphaso zatsopano zingapo:

• Ma tubeless upper arm blood pressure monitors - omwe amapereka kusuntha kwamphamvu komanso luso la ogwiritsa ntchito.

• Zowunikira zazikulu za digito za BP (DBP-6186 / 6286B) - zopangidwira kukula kwa mikono (40-56 cm), ndi zosankha za Bluetooth.

• Compressor nebulizers (NB-1100 mpaka NB-1103) - FDA-yotsutsidwa pansi pa Product Code CAF, yothandizira chithandizo chodalirika cha kupuma kunyumba kapena m'zipatala.

Chitsimikizo cha EU MDR

Joytech ndi m'gulu la opanga oyamba ku China kuti akwaniritse chiphaso cha EU MDR pansi pa lamulo latsopanoli. Mu Epulo 2022 , tidalandira satifiketi yathu yoyambirira ya MDR kuchokera ku TÜV SÜD, yophimba zinthu monga zoyezera kutentha kwa digito, zoyezera kutentha (khutu & pamphumi), mapampu a mabere, ndi zowunikira zomwe sizimasokoneza kuthamanga kwa magazi, zomwe zikuwonetsa kuvomereza koyamba kwa MDR ku China m'magulu angapo kuphatikiza ma thermometer amagetsi ndi mapampu am'mawere.

Kuyambira nthawi imeneyo, takhala tikupitiriza kukulitsa mbiri yathu ya MDR-certified portfolio chaka chilichonse. Pofika mu Okutobala 2023 , zowunikira zonse za m'badwo watsopano wa kuthamanga kwa magazi ndi zoyezera kutentha zidalandira chilolezo cha CE (MDR). Pofika mu February 2025 , gulu lathu lachinayi lazinthu zovomerezeka likuphatikiza:

• Onse nebulizers

• ECG yowunika kuthamanga kwa magazi

• Oyang'anira zizindikiro zofunika

• Zida zonse zolumikizidwa ndi Bluetooth

• Mapampu onse am'mawere

Kukula kosalekezaku kukuwonetsa kudzipereka kwakukulu kwa Joytech pakutsata, kupanga zinthu zatsopano, komanso kuchita bwino pakuwongolera. Kapangidwe kathu kazinthu zonse, kupanga, kuyesa, kupanga, zolemba, kuwunika pambuyo pa msika, kumakwaniritsa miyezo yokhwima kwambiri ku Europe, kupatsa mphamvu anzathu ndi mayankho otsimikizika, okonzeka kugulidwa ku EU.

Miyezo ina Yoyang'anira

Njira zathu zopangira ndi zovomerezeka pansi pa ISO 13485 ndi MDSAP , zomwe zimakwaniritsa zosowa za US, Canada, Australia, Japan, ndi Brazil.

Komanso, zinthu za Joytech zimagwirizananso ndi malangizo a NMPA (China), RoHS, ndi REACH, zokhudzana ndi chitetezo, chilengedwe, ndi zolemba ku Asia ndi EU.

Zomwe Zikutanthauza kwa Othandizana nawo？

Kugwira ntchito ndi Joytech kumatanthawuza zambiri kuposa kungopeza mankhwala-kumatanthauza kupeza bwenzi labwino lomwe limamvetsetsa zovuta za kutsata mayiko.

v Ziwopsezo zotsika ndi mtengo wake - Ziphaso zathu zokonzeka kupita komanso luso lathu pofufuza zapadziko lonse lapansi zimachepetsa mtolo wolembetsera kwanuko.

v Kufikira mwachangu pamsika - Ndi zida zotsimikiziridwa kale, mutha kuyambitsa madera omwe mukufuna mwachangu komanso kuchedwa kochepa.

v Thandizo laukadaulo ndi zamankhwala - Kuchokera pazolembedwa zaukadaulo kupita ku data yachipatala, gulu lathu loyang'anira m'nyumba limapereka chithandizo chogwirizana ndi zomwe mukufuna kudziko lanu.

v Ubwino wotsimikizirika ndi kukonzeka kwa kafukufuku - Dongosolo lathu labwino ladutsa ma audition angapo a gulu lachitatu, ndipo zolembedwa zathu nthawi zonse zimakhala zokonzeka kuwunika, kuwonetsetsa kuti zikuyenda bwino komanso zowoneka bwino.

POMALIZA:
Pamene malamulo akusintha, ifenso tidzatero. Joytech yadzipereka mosalekeza kukulitsa mayendedwe ake apadziko lonse lapansi ndi ziphaso monga FDA ndi MDR - kuwonetsetsa kuti anzathu ali ndi mwayi wopeza zida zamankhwala zovomerezeka, zapamwamba kwambiri m'misika yolamulidwa.

Tili ndi ziphaso kale kumadera akuluakulu apadziko lonse lapansi, kuphatikiza North America, EU, Asia, ndi kupitilira apo.

Mukufuna kudziwa ngati ndife ovomerezeka pamsika wanu?

Mukuyang'ana njira yokonzekera OEM/ODM?

Lumikizanani ndi gulu lathu lero kuti mufufuze zambiri za certification zazinthu, zolemba zaukadaulo, ndi mayankho ogwirizana ndi polojekiti yanu. Ndi Joytech, kumvera kumakhala mwayi wanu wampikisano.