Ngokwandiswa kokuqiniswa kommiselo wesixhobo sehlabathi, iinkampani zaphesheya ezingena kwiimarike ze-European kunye neMelika kufuneka zihlangane nje neemfuno zentengiso yangaphambi kwentengiso yentengiso yangaphambi kwentengiso, kodwa zihlolisisa ngendawo yokujonga (i-PMS). Kukho umahluko obonakalayo kwiindlela ze-Logic ezilawulayo, iindlela zokuhlola iindlela kunye nezohlwayo phakathi kwe-US FDA kunye ne-EU MDR / IVDR.
Yintoni i-FDA (i-US yokutya kunye nolawulo lweziyobisi) ?
i-FDA ilawula ukhuseleko kunye nokusebenza kwezixhobo zezonyango eUnited States. Kwizixhobo ezininzi, abavelisi kufuneka bangenise i-510 (k) ukungqina ukuba imveliso yabo ikhuselekile, isebenza kwaye ilingana kakhulu nesixhobo esivunyiweyo.
Yintoni i-MDR (Ummiselo wesixhobo sonyango) ?
I-MDR ngummiselo we-European Union ngezixhobo zonyango, endaweni ye-MDD yangaphambili (isikhokelo sesixhobo sonyango). Ineemfuno zovavanyo lweklinikhi, ukuhlolwa kwentengiso emva kwentengiso, kunye namaxwebhu obuchwephesha ukuqinisekisa ukhuseleko oluninzi lwezigulana oluphezulu kunye nokungafihlisi.
Ukuhambahamba bobabini i-FDA kunye ne-MDR inzima - kodwa ibaluleke kakhulu. EJoytech, sakha inkqubo yokuthobela i-tudstround yokunceda amaqabane ethu oshishino ahlangabezana nale migangatho ifunwayo. Nokuba uyanda e-US okanye ungene kwi-EU phantsi kwe-MDR, iimveliso zethu eziqinisekisiweyo, amaxwebhu ezobuchwephesha, kunye nobuchule bokulawula balapha ukukuxhasa.
W ha h e ave?
EJoytech, senze isiseko esiqinileyo sokuxhobisa amaqabane ethu kwihlabathi liphela. UJoytech uye wakhela inkqubo yokuthobela ngokubanzi kwaye ejonge phambili ejonga iimfuno zolawulo lwehlabathi zonke kwiimarike ezinkulu zonyango.
I-FDA 510 (k) imvume
UJoytech kudala ukuseka ubukho obuqinileyo kwimarike yaseMelika, kunye nayo yonke imigca yethu yemveliso ephambili ecociweyo kwaye inikezelwa ngamaqabane ehlabathi. Ukwakha kwesi siseko esiqinisekisiweyo, ngokuqhubekayo kutyala imali kubuchule bemveliso kunye nokuhlaziywa komthetho ukuze kufezekiswe iimfuno zeklinikhi kunye neemfuno zeprojekthi ethile.
Ngowama-2025, sayindisa iphothifoliyo yethu ye-FDA ngeziqinisekiso ezininzi ezintsha:
I-Tube engenayo igazi engaqhelekanga yegazi igazi - ukubonelela ngezinyameko kunye namava abasebenzisi.
I-BP enkulu ye-BP i-BP ye-BP ye-Reandourtal BP (i-DBP-6186 / 6286B) - Yenzelwe inani lengalo eyongezelelweyo (40-56 cm), ngeendlela zeBluetooth.
I-Acpressor Nebulizers (NB-1100 kwi-NB-1103) - i-FDA-icociwe phantsi kwekhowudi yemveliso ye-CAF, ixhasa unyango oluthembekileyo ekhaya okanye ezikliniki.
Isatifikethi se-EU MDR
UJoytech uphakathi kwabavelisi bokuqala baseTshayina ukufezekisa isiqinisekiso se-EU MDR phantsi kommiselo omtsha. Ngo- Epreli 2022 , safumana isatifikethi sethu sokuqala se-TÜV SÜD, esigubungela iimveliso ezifana ne-thermometers yegazi, i-thermometers kunye ne-upermometers yegazi, kunye ne-Pumps, kunye nePumps yokuqala ye-MDR kubandakanywa i-elektroniki kunye neempompo zebele.
Ukususela ngoko, siqhubekile nokwandisa iphothifoliyo yethu ye-MDR ngonyaka. Ngo -Okthobha 2023 , bonke abantu abahlonitshwa amatsha-nqaba amatsha kunye ne-thermometer bafumene imvume ye-CE (MDR). Ukusukela ngoFebruwari 2025 , ibhendi yethu yesine yeemveliso eziqinisekisiweyo ibandakanya:
Olu lwando oluqhubekayo lubonisa ukuzibophelela ngokunzulu kukaGowech ekuthotyelweni, ubuchule bemveliso, kunye nokugqwesa kulawulo. Imveliso yethu epheleleyo yeNdawo, ukuvavanywa, ukuSebenza, amaxwebhu, kunye nokujonga emva kwentengiso - ukudibanisa imigangatho yentengiso yaseYurophu, ukuxhobisa amaqabane aqinisekileyo, kwimakethi elungiselelwe i-EU.
Imigangatho yomthetho
Iinkqubo zethu zokwenza izinto eziqinisekiswa ziqinisekiswa phantsi kwe -ISO 13485 kunye neMdaba , intlanganiso kwiimfuno ze-US, eCanada, eOstreliya, e-Australia, naseBrazil.
Kananjalo, iimveliso zeJodtech zikwavumelana ne-NMPA (i-china), i-rohs, kwaye ufikelela kumyalelo, ukuhlangabezana nokhuseleko, okusingqongileyo, kunye ne-EU.
Ithetha ukuthini amaqabane ethu？
Ukusebenza kunye neJotech kuthetha okungaphezulu kokufumana imveliso - kuthetha ukufumana iqabane eliqondayo eliqonda ukubaluleka kokuthotyelwa kwezizwe ngezizwe.
v umngcipheko wemingcipheko ophantsi kunye neendleko - iziqinisekiso zethu zokugcina kunye namava ngophicotho-zincwadi lwehlabathi zinciphisa umthwalo kwinkqubo yakho yobhaliso.
v Ukufikelela kwimakethi yemakethi yentengiso -ngezixhobo eziqinisekisiweyo, unokwazisa kwimimandla ekujoliswe kuyo enesantya esikhulu kunye nokulibaziseka okumbalwa.
v Inkxaso yezobugcisa kunye neklinikhi -ukusuka kumaxwebhu obuchwephesha kwidatha yeklinikhi, iqela lethu le-In-ndlu ibonelela ngenkxaso elungiselelwe ukufezekisa iimfuno zakho zelizwe.
v Umgangatho ongqinisisiweyo kunye nokulungela uphicotho-zincwadi -inkqubo yethu esemgangathweni idlule iiphiwo zophicotho-zincwadi zeqela lesithathu, kunye namaxwebhu ethu bahlala begcinwa ziphicotho-zincwadi, ukuqinisekisa ukucaca kunye nokusebenza kakuhle kunye nokusebenza kakuhle.
I-Intyinti:
Njengommiselo uvela, siya kuthi. UJoytech uzibophelele ekuqhubekeni ngokuqhubekeka ukwandisa indlela yayo yokuthobela i-jifaphu kunye nokuqinisekiswa njenge- FDA kunye ne -MDR -ung Izixhobo zethu zonyango zingenakuphazamisekile kwiimakethi ezilawulwayo.
Sele sibambe iziqinisekiso kwimimandla emikhulu yehlabathi, kubandakanya noMntla Merika, i-EU, iAsia, nangaphaya.
Ngaba ufuna ukwazi ukuba uqinisekisiwe kwintengiso yakho?
Ngaba ujonge isisombululo esisemthethweni se-oem / i-ODM?
Qhagamshela neqela lethu namhlanje ukuphonononga iinkcukacha zesiqinisekiso semveliso, amaxwebhu obuchwephesha, kunye nezisombululo zeprojekthi yakho. Ndikunye noJoytech, ukuthotyelwa kuba yingenelo yakho.
