Ngokunyuka kokuqiniswa kokulawulwa kwezixhobo zonyango zehlabathi, iinkampani zaphesheya kwezilwandle ezingena kwiimarike zaseYurophu nezaseMelika kufuneka zihlangabezane kungekuphela nje iimfuno ezintsonkothileyo zokuvunywa kwangaphambili, kodwa zijongana noHlolo olungqongqo lweFlying (Akukho Uhlolo lweSaziso) kunye nePost-Market Surveillance (PMS). Kukho ukungafani okuphawulekayo kwingqiqo yokulawula, iindlela zokuhlola kunye nezohlwayo phakathi kwe-US FDA kunye ne-EU MDR / IVDR.
Yintoni i-FDA (US Food and Drug Administration) ?
I-FDA ilawula ukhuseleko kunye nokusebenza kwezixhobo zonyango e-United States. Kwizixhobo ezininzi, abavelisi kufuneka bangenise i-510(k) ukubonisa ukuba imveliso yabo ikhuselekile, iyasebenza, kwaye ilingana kakhulu nesixhobo esisele sivunyiwe.
Yintoni i-MDR (Medical Device Regulation) ?
i-MDR ngummiselo we-European Union kwizixhobo zonyango, ithatha indawo ye-MDD yangaphambili (i-Medical Device Directive). Ineemfuno ezingqongqo zovavanyo lweklinikhi, ukucupha emva kokuthengisa, kunye namaxwebhu obugcisa ukuqinisekisa ukhuseleko oluphezulu lwesigulane kunye nokungafihli.
Ukuhamba nge-FDA kunye ne-MDR kunzima-kodwa kubalulekile. KwaJoytech, sakhe inkqubo yokuthobela eyomeleleyo yehlabathi ukunceda amaqabane ethu oshishino ahlangabezane nale migangatho ifunekayo ngokuzithemba. Nokuba uyakhula uye e-US okanye ungena kwi-EU phantsi kwe-MDR, iimveliso zethu eziqinisekisiweyo, amaxwebhu obugcisa, kunye nobuchule bokulawula zilapha ukuze zikuxhase.
Senza ntoni na ?
KwaJoytech, siseke isiseko esiluqilima solawulo ukuxhobisa amaqabane ethu kwihlabathi liphela. I-Joytech yakhe isikhokelo sokuthobela esibanzi nesijonge phambili esihlangabezana neemfuno zolawulo lwehlabathi kuzo zonke iimarike ezinkulu zonyango.
I-FDA 510(k) Usulelo
I-Joytech kudala iseka ubukho obuqinileyo kwimarike yase-US, kunye nayo yonke imigca yethu yemveliso engundoqo esele isusiwe i-FDA kwaye ibonelelwe ngokusebenzayo kumaqabane ehlabathi. Ukwakha phezu kwesi siseko siqinisekisiweyo, siqhuba utyalo-mali ekuyilweni kwemveliso kunye nohlaziyo lolawulo ukuze sihlangabezane neemfuno eziguqukayo zeklinikhi kunye neemfuno zeprojekthi ezingqamene neqabane.
Ngo-2025, sandise ipotifoliyo yethu ye-FDA ngeziqinisekiso ezininzi ezitsha:
I-Tubeless upper arm monitors yoxinzelelo lwegazi- inika ukuphatheka okuphuculweyo kunye namava omsebenzisi.
Iimonitha ze-BP zedijithali zengalo enkulu (DBP-6186 / 6286B) - ziyilelwe ubungakanani bengalo ezongeziweyo (40-56 cm), kunye neenketho zeBluetooth.
I-Compressor nebulizers (NB-1100 ukuya kwi-NB-1103) - I-FDA-icaciswe phantsi kweKhowudi yeMveliso ye-CAF, exhasa unyango oluthembekileyo lokuphefumla ekhaya okanye kwiiklinikhi.
Isiqinisekiso se-EU MDR
IJoytech iphakathi kwabavelisi bokuqala baseTshayina ukufikelela kwisatifikethi se-EU MDR phantsi kommiselo omtsha. Ngo -Epreli ka-2022 , safumana isatifikethi sethu sokuqala se-MDR kwi-TÜV SÜD, egubungela iimveliso ezifana nethemometha yedijithali, i-thermometers ye-infrared (indlebe kunye nebunzi), iimpompo zebele, kunye nezingameli zoxinzelelo lwegazi ezingahlaseli-eziphawula imvume yokuqala ye-MDR e-China kwiindidi ezininzi ezibandakanya i-thermometers zombane kunye neepompo zamabele.
Ukusukela ngoko, siye saqhubeka nokwandisa iphothifoliyo yethu eqinisekisiweyo ye-MDR ngonyaka. Ngo- Oktobha 2023 , zonke iimonitha zoxinzelelo lwegazi zesizukulwana esitsha kunye ne-thermometers zifumene imvume ye-CE (MDR). Ukusukela ngoFebruwari 2025 , ibhetshi yethu yesine yeemveliso eziqinisekisiweyo ibandakanya:
Olu lwando luqhubekayo lubonisa ukuzibophelela okunzulu kukaJoytech ekuthotyelweni, ekuyilweni kwemveliso, kunye nokugqwesa kolawulo. Ubomi bethu bemveliso epheleleyo-uyilo, uvavanyo, ukuveliswa, ukubhalwa kwamaxwebhu, kunye nokuphononongwa emva kokuthengisa-kuhlangabezana neyona migangatho ingqongqo yaseYurophu, ixhobisa amaqabane ethu ngezisombululo eziqinisekisiweyo, ezilungele ukuthengiswa kwi-EU.
Eminye iMigangatho yoLawulo
Iinkqubo zethu zokuvelisa ziqinisekiswa phantsi kwe -ISO 13485 kunye ne -MDSAP , ehlangabezana neemfuno zolawulo lwase-US, eKhanada, e-Australia, eJapan, naseBrazil.
Kwakhona, iimveliso ze-Joytech zikwahambelana ne-NMPA (e-China), i-RoHS, kunye ne-REACH izikhokelo, ukhuseleko lokuhlangana, indalo, kunye nemigangatho yamaxwebhu kulo lonke elase-Asiya kunye ne-EU.
Ithetha Ntoni Kumaqabane Ethu？
Ukusebenza noJoytech kuthetha okungaphezulu nje kokukhangela imveliso-ithetha ukufumana iqabane lobuchule eliqondayo ubunzima bokuthotyelwa kwamazwe ngamazwe.
v Imingcipheko ephantsi yolawulo kunye neendleko - Izatifikethi zethu ezilungele ukuhamba kunye namava ngophicotho-zincwadi lwehlabathi anciphisa umthwalo kwinkqubo yakho yobhaliso yasekhaya.
v Ukufikelela kwimarike ngokukhawuleza - Ngezixhobo eziqinisekisiweyo kwangaphambili, unokuqalisa kwimimandla ekujoliswe kuyo ngesantya esikhulu kunye nokulibaziseka okumbalwa.
v Inkxaso yobugcisa kunye neklinikhi eyenziwe ngokwezifiso - Ukusuka kumaxwebhu obugcisa ukuya kwidatha yeklinikhi, iqela lethu elilawulayo langaphakathi libonelela ngenkxaso elungiselelwe ukuhlangabezana neemfuno zelizwe lakho.
v Umgangatho oqinisekisiweyo kunye nokulungela ukuphicothwa kweencwadi - Inkqubo yethu yomgangatho iphumelele uphicotho oluninzi lomntu wesithathu, kwaye amaxwebhu ethu ahlala egcinwe elungele uphicotho, eqinisekisa ukungafihli kunye nokusebenza kakuhle.
ISIPHELO:
Njengoko imimiselo iguquka, nathi siya kuba njalo. I-Joytech izimisele ngokuqhubekayo ukwandisa imephu yendlela yokuthotyelwa kwehlabathi kunye neziqinisekiso ezifana ne -FDA kunye ne-MDR -ukuqinisekisa ukuba amaqabane ethu angenasiphazamiso ukufikelela kwizixhobo zonyango eziqinisekisiweyo, ezikumgangatho ophezulu kwiimarike ezilawulwayo.
Sele sibambe izatifikethi kuyo yonke imimandla emikhulu yehlabathi, kubandakanya uMntla Melika, i-EU, iAsia, nangaphaya.
Ngaba uyafuna ukwazi ukuba siqinisekisiwe kwimarike yakho?
Ngaba ujonge isisombululo se-OEM/ODM esilungele ukulawula?
Qhagamshelana neqela lethu namhlanje ukuze ujonge iinkcukacha zesatifikethi semveliso, amaxwebhu obugcisa, kunye nezisombululo ezilungiselelwe iprojekthi yakho. NgeJoytech, ukuthobela kuba yinzuzo yakho yokhuphiswano.
