I-China Leading Medical Catheter OEM Supplier DAXAN: CE MDR, FDA 510(k), kanye nokubhaliswa kwe-NMPA yabangenisa kwamanye amazwe

Ukukhetha okuthembekile Umhlinzeki we-OEM we-Catheter Yezokwelapha Ingabe i-China ihilela okungaphezu kokuhlola izindleko zamayunithi kanye nomthamo wokukhiqiza. Kwabangenisi bamazwe ngamazwe, imfuneko enqumayo ukumbozwa kwemithetho: ingabe umenzi oyedwa uphethe i-stack yokuthobela imithetho - i-EU MDR 2017/745, i-US FDA 510(k), kanye ne-China NMPA - ehlangabezana nomkhawulo ngamunye we-qualification wemakethe okuhlosiwe? Bambalwa kakhulu abakhiqizi be-catheter baseShayina abangaphendula ngoyebo kubo bonke abathathu.

I-DAXAN — uhlobo lwezentengiselwano lwe-Chengdu Daxan Innovative Medical Tech Co., Ltd., eyasungulwa eChengdu ngo-2016 — yakhe ukwakheka komthetho ngqo. Isebenza kusukela egumbini lokuhlanza eliqinisekiswe yi-ISO 13485:2016 elingamamitha-skwele angu-6,000 elinesikhungo sokuhlola esihlanganisiwe, inkampani ikhiqiza ama-catheter angaphezu kwezigidi ezingu-20 aphilizayo minyaka yonke futhi ithumela kwamanye amazwe angaphezu kuka-25, ikhonza abasabalalisi, abanikazi bomkhiqizo, kanye nabalingani be-OEM kulo lonke elaseYurophu, eNyakatho Melika, kanye nesifunda sase-Asia-Pacific.

Lesi sitatimende sabezindaba sichaza uhlaka lokulawula olunezigaba ezintathu i-DAXAN elumisile njengomhlinzeki we-OEM we-catheter yezokwelapha, isisekelo sokukhiqiza esisekelayo, kanye nobubanzi bokwenza ngokwezifiso i-OEM obutholakala kubangenisi bamazwe ngamazwe.

I-DAXAN Iqinisekisa Isitifiketi Sokulawula Esiphindwe Kathathu Njengomhlinzeki We-OEM We-Catheter Yezokwelapha Kwabangenisi Bamazwe Ngamazwe

I-Chengdu Daxan Innovative Medical Tech Co., Ltd. iqinisekisile isitifiketi ngesikhathi esisodwa kuzo zonke izinhlaka ezintathu ezizimele zomthetho: i-CE Marking ngaphansi kwe-EU MDR 2017/745 (indlela yokuqinisekisa ikhwalithi ephelele), i-FDA 510(k) clearances K212567 kanye ne-K243175, kanye nokubhaliswa kwe-China NMPA (eyayikade iyi-CFDA) — konke kusekelwe ohlelweni lokuphatha ikhwalithi lwe-ISO 13485:2016. Kuhlanganiswe ne-FDA Establishment Registration FEI 3023329815, le portfolio yokuthobela imithetho ibeka i-DAXAN phakathi kweqembu elincane labakhiqizi be-urology baseShayina abangasekela iziqu zabangenisi bezimakethe zasekhaya ze-EU, US, kanye neShayina abavela emthonjeni owodwa.

Abathumeli bamazwe ngamazwe abahlola umhlinzeki we-OEM we-catheter yezokwelapha bavame ukuvula ukuhlolwa kwabo ezingeni lesitifiketi: Abathengi be-EU baqinisekisa ukuthobela i-CE MDR kanye nendlela ethile ye-Notified Body; Abathengi base-US bacela izinombolo ze-510(k) K kanye nokubhaliswa kwesikhungo; Amaqembu okuthenga ase-Asia-Pacific aqinisekisa isimo se-NMPA kanye nemibhalo yokuthumela kwamanye amazwe.

Ukuhambisana ne-CE MDR 2017/745: Indlela Yokuqinisekisa Ikhwalithi Egcwele Yabangenisi Be-Catheter Yezokwelapha baseYurophu

I-DAXAN iphethe i-CE Marking ngaphansi kwe-EU MDR 2017/745 ngendlela ye-Full Quality Assurance — umzila obeka uhlelo lokuthuthukiswa komklamo oluphelele kanye nekhwalithi yokukhiqiza ngaphansi kokuphathwa kwe-Notified Body, kunokuba kuhlolwe uhlobo lomkhiqizo kanye kuphela. Ama-catheter ahlala isikhathi eside ahlukaniswa njengamadivayisi ezokwelapha e-Class IIa ngaphansi kwe-MDR 2017/745, futhi abathumeli be-EU kanye ne-EEA abakwazi ukuwabeka emakethe yaseYurophu ngaphandle kophawu lwe-CE olusebenzayo olukhishwe ngaphansi komthethonqubo obuyekeziwe.

Kwabangenisi be-EU ababuyekeze izintambo zokuphakelwa kusukela ekuguqukeni kwe-MDR, umzila we-Full Quality Assurance ubonisa izinga eliphezulu lokuzibandakanya kwabakhiqizi nezidingo zomthetho zaseYurophu. Izilawuli zokuklama, amarekhodi okukhiqiza amaqoqo, ukubika kokuqapha ngemuva kwemakethe, kanye nephakheji yamadokhumenti obuchwepheshe konke kubuyekezwa futhi kuqashwe yi-Notified Body eqinisekisayo - akukahlolwa kanye futhi kushiywe kungashintshi.

Isitifiketi se-CE MDR se-DAXAN sihlanganisa imigqa yayo yomkhiqizo we-catheter embozwe ngamanzi. Uhlelo lwekhwalithi lwe-ISO 13485:2016 oluyisisekelo luvumelanisa ukwakheka kwemibhalo yobuchwepheshe nesakhiwo abathumeli be-EU abalindele ukusifaka ngesikhathi sokubhaliswa kwegunya elifanele likazwelonke.

Izivumelwano ze-FDA 510(k) ezimbili K212567 kanye ne-K243175: Ukufinyelela Emakethe Yase-US Kwama-Catheter Ahlala Emanzi kanye Ne-TPU

I-DAXAN inezimvume ezimbili ezizimele ze-FDA 510(k): i-K212567, emboza umugqa wayo we-catheter onama-hydrophilic-coated intermittent catheter, kanye ne-K243175, emboza uchungechunge lwayo lwe-TPU intermittent catheter. Zombili izinombolo ze-K ziseshwa esidlangalaleni kudathabheyisi ye-FDA 510(k), okunikeza abathumeli base-US imibhalo yokufinyelela emakethe yomkhiqizo eqinisekisiwe ngokuzimela endaweni yokuhlola umhlinzeki.

Isakhiwo sokususa okubili sibonisa imigqa emibili eyinhloko ye-DAXAN. Abasabalalisi base-US bathola ama-catheter e-PVC ajwayelekile aphilizayo abhekisela ku-K212567; labo abathola ireferensi ye-TPU ehlukile evumelana nomzimba i-K243175.

Kanye nokukhishwa kwemikhiqizo, i-DAXAN ine-FDA Establishment Registration FEI 3023329815, engaseshwa ngerejista yesikhungo se-FDA eku-inthanethi. Ukuvunyelwa kwesigaba somkhiqizo esingu-510(k) okuhlanganiswe nokubhaliswa kwesigaba sesikhungo se-FDA kwakha isakhiwo semibhalo esinezingqimba ezimbili esidingwa amaqembu ezindaba zokulawula abangenisi base-US ngaphambi kokuqeda iziqu zomhlinzeki.

Ukubhaliswa kwe-NMPA kanye neMibhalo Yokuthumela Ngaphandle: Iziqinisekiso Zokuthobela Imithetho zaseShayina Zabalingani Bokusabalalisa base-Asia

Ukubhaliswa kwe-NMPA yaseShayina (eyayikade iyi-CFDA) kuqinisekisa ukuthi imikhiqizo ye-catheter ye-DAXAN ihlangabezane nokubuyekezwa komthetho wasekhaya ngaphansi kohlaka lwedivayisi yezokwelapha yaseShayina — ehlanganisa ukuhambisana kwezindinganiso zomkhiqizo, ukuhlolwa kwesistimu yekhwalithi, kanye nezidingo zokuqapha ngemuva kwemakethe. Kwabangenisi base-Asia-Pacific abanezinqubo zabo zokubhalisa zasendaweni ezibhekisela esimweni somthetho sezwe elikhiqizayo, ukubhaliswa kwe-NMPA kunikeza isignali yokuthobela umthetho eqashelwayo evela emthonjeni.

I-DAXAN iphinde ibe neSitifiketi Sokuthengisa Samahhala (i-FSC) kanye neSitifiketi Sokuqala se-CCPIT. I-FSC iqinisekisa ukufaneleka kokuthumela kwamanye amazwe ezimakethe ezingaphandle kwezinhlaka zomthetho ze-EU kanye ne-US - ezivame ukudingwa ngabangenisi eNingizimu-mpumalanga ye-Asia, eMpumalanga Ephakathi, naseLatin America lapho befaka izicelo zokungena emakethe noma zokubhalisa umkhiqizo. ISitifiketi Sokuqala se-CCPIT sisebenzisa imisebenzi yamadokhumenti amasiko kanye nentela ekuhwebeni kwamanye amazwe, okuqinisekisa imvelaphi yaseShayina yokuhlola intela kanye nokuhambisana nesivumelwano sokusabalalisa.

Ndawonye, ​​ukubhaliswa kwe-NMPA, i-FSC, kanye nesitifiketi sokuqala se-CCPIT kunikeza abalingani bokusabalalisa ezimakethe ezisafufusa iphakheji ephelele, yamadokhumenti yomthombo owodwa: ukuthobela imithetho yomkhiqizo evela ezweni elikhiqizayo, ukuba semthethweni kokuthumela kwamanye amazwe, kanye nokuqinisekiswa kokuqala.

Isikhungo Sokuhlanza se-ISO 13485:2016 kanye Nomthamo Waminyaka Yonke we-20M: Isisekelo Sokukhiqiza Esisekela Isitifiketi Semakethe Emithathu

Zonke iziqinisekiso zokulawula kuphothifoliyo ye-DAXAN zisekelwe esisekelweni esifanayo sokukhiqiza: igumbi lokuhlanza eliqinisekiswe yi-ISO 13485:2016 elingamamitha-skwele angu-6,000 eChengdu, elisekelwa yisikhungo sokuhlola esihlanganisiwe futhi likhiqiza ama-catheter angaphezu kwezigidi ezingu-20 aphiliza amanzi ngonyaka. Uhlelo lokuphatha ikhwalithi lwe-ISO 13485:2016 aluyona nje isitifiketi esidingekayo - luyisixhumanisi sesakhiwo esixhumanisa zonke izinhlaka ezintathu zokulawula ngasikhathi sinye.

Imibhalo yobuchwepheshe ye-CE MDR, uMthethonqubo Wekhwalithi we-FDA, kanye nemigomo yokuhlola ye-NMPA konke kuphatha i-ISO 13485 njengomgogodla wabo wesakhiwo. Ngenxa yokuthi i-QMS eyodwa eqinisekisiwe isekela konke ukubhaliswa okuthathu, abangenisi ababuyekezi izakhiwo ezintathu zokuthobela imithetho efanayo - bahlola indawo eyodwa yokukhiqiza ebhalwe phansi eyanelisa abalawuli abathathu, inzuzo yokusebenza kahle enenjongo yomhlinzeki.

Umthamo wokukhiqiza waminyaka yonke ongu-20M+ unikeza abangenisi ukuzinza kokunikezwa okudingekayo kwezinkontileka zohlaka, izinhlelo zelebula ezizimele ze-multi-SKU, kanye nezivumelwano zokusabalalisa eziguquguqukayo zomthamo.

Izinhlelo ze-OEM Catheter zabangenisi: Osayizi be-FR CH06–CH24, Ukucushwa Kwamathiphu Amane, kanye Nokulebula Kwangasese

KWESOKUDLAUhlelo lwe-OEM lwe-OEM luhlelwe ngabangenisi abaphatha amaphothifoliyo e-catheter e-urology amaningi e-SKU. Ukumbozwa kosayizi waseFrance kuhlanganisa i-CH06 kuya ku-CH24, ngobude kanye nokucushwa kwe-tip okuchazwe ngemakethe eqondiwe kanye nenani leziguli. Kunezinhlobo ezine ze-tip ezitholakalayo — i-Nelaton straight, i-Tiemann coude, i-ball, kanye ne-flexible — ezihlangabezana nezidingo zezokwelapha kuzo zonke izinzwa zesinyi, i-BPH, i-urethral stricture, kanye nezinkomba ezijwayelekile zokuzihlikihla. Ukukhethwa kwezinto kuhlanganisa i-PVC yezinga lezokwelapha kanye ne-DEHP-free, i-BPA-free TPU, kanye nokupakishwa kwelebula yangasese okungenziwa ngokwezifiso ngomkhiqizo, ulimi, kanye neyunithi yokusabalalisa.

Isembozo esinamathela emanzini esisetshenziswa kububanzi be-catheter ye-OEM ye-DAXAN yiplatifomu ye-Coatapex™ Hydrolyx™ — ifomula esekelwe ku-PVP eyenzelwe ukungqubuzana okuphansi kakhulu kwendawo kanye nokuthambisa okuzinzile kahle ngemva kokusebenza. Iplatifomu yesembozo se-OEM isekelwa yi-DAXAN Patent Nos. ZL201610861058.4 kanye ne-ZL201811203221.3.

Imindeni yemikhiqizo ye-OEM etholakalayo ezinhlelweni zelebula ezizimele ifaka phakathi i-hydrophilic Uhla lwe-catheter oluqondile lwe-Nelaton, umugqa we-catheter we-Duro-Pocket® ovaliwe ohlelweni kokubili kumafomethi e-RTU kanye ne-water sachet activated, kanye I-catheter ye-ISC ene-flexible-tip ye-DuroFlex™ kwezicelo zokwakheka komzimba wabesilisa. Umugqa ngamunye womkhiqizo wenziwa ngaphakathi kwegumbi lokuhlanza le-DAXAN le-ISO 13485 futhi unezitifiketi ze-CE MDR, FDA 510(k), kanye ne-NMPA ezifanele indlela yemakethe yawo.

Kwabangenisi abahlanganisa ukuthobela imithetho, amandla okuphakelwa, kanye nokuguquguquka kwe-OEM ebudlelwaneni bomhlinzeki we-OEM we-catheter yezokwelapha eyodwa, i-Chengdu Daxan Innovative Medical Tech Co., Ltd. iveza inketho yokukhiqiza ebhalwe phansi nengahlolwa. Imininingwane yomkhiqizo, amaphakheji amadokhumenti okulawula, kanye nemininingwane yohlelo lwe-OEM iyatholakala ngqo ngokusebenzisa www.daxanmedical.com.