China Inotungamira Medical Catheter OEM Supplier DAXAN: CE MDR, FDA 510(k), uye NMPA Kunyoresa kune Vanobva kunze

Kusarudza chinhu chakavimbika Mutengesi weCatheter yekurapa weOEM kubva kuChina kunosanganisira zvinopfuura kungoongorora mutengo weyuniti uye kugona kwayo kugadzira. Kune vanopinza kunze kwenyika, chinodiwa ndechekuvhara mitemo: mugadziri mumwe chete ane here mutemo wekutevedzera mitemo - EU MDR 2017/745, US FDA 510(k), uye China NMPA - inozadzisa chiyero chemusika wega wega? Vagadziri vashoma kwazvo vecatheter vekuChina vanogona kupindura kuti hongu kune ese matatu.

DAXAN — kambani yekutengeserana yeChengdu Daxan Innovative Medical Tech Co., Ltd., yakavambwa muChengdu muna 2016 — yakavaka hurongwa hwakadaro hwemitemo. Ichishanda kubva mukamuri rekushambidza rine 6,000 m² ISO 13485:2016 rine nzvimbo yekuyedza yakabatana, kambani iyi inogadzira macatheter anodarika mamiriyoni makumi maviri anonyungudika emvura gore rega rega uye inotumira kunze kwenyika dzinopfuura makumi maviri neshanu, ichishandira vatengesi, varidzi vezvigadzirwa, uye vadyidzani veOEM muEurope, North America, uye dunhu reAsia-Pacific.

Chiziviso ichi chinotsanangura hurongwa hwemitemo hune matanho matatu hwakatangwa neDAXAN semupi wezvigadzirwa zveOEM zvekurapa, hwaro hwekugadzira hunohutsigira, uye chiyero chekugadzirisa cheOEM chinowanikwa kune vanopinza kunze kwenyika.

DAXAN Inosimbisa Triple Regulatory Certification seMutengesi weOEM weMedical Catheter kune Vanopinza Nyika Dzepasi Pose

Chengdu Daxan Innovative Medical Tech Co., Ltd. yakasimbisa zvitupa panguva imwe chete muzvikamu zvitatu zvemutemo zvakazvimirira: CE Marking pasi peEU MDR 2017/745 (Full Quality Assurance pathway), FDA 510(k) clearances K212567 neK243175, uye China NMPA (yaimbove CFDA) registration — zvese zvinotsigirwa neISO 13485:2016 quality management system. Pamwe chete neFDA Establishment Registration FEI 3023329815, portfolio iyi yekutevedzera mitemo inoisa DAXAN pakati peboka diki revagadziri veurology vekuChina vanogona kutsigira zvinodiwa nevanopinza misika yemuno yeEU, US, neChina kubva kune imwe nzvimbo.

Vatengesi vekunze kwenyika vanoongorora mutengesi we catheter yekurapa OEM vanowanzo vhura ongororo yavo padanho rechitupa: Vatengi veEU vanosimbisa kutevedzera kweCE MDR uye nzira chaiyo yeNotified Body; Vatengi vekuUS vanokumbira 510(k) K-nhamba uye kunyoreswa kwenzvimbo; Matimu ekutenga eAsia-Pacific anosimbisa mamiriro eNMPA uye magwaro ekutumira kunze kwenyika.

Kutevedzera mitemo yeCE MDR 2017/745: Nzira Yekuvimbisa Hunhu Hwakazara kune Vanotenga Catheter Yekurapa muEurope

DAXAN ine CE Marking pasi peEU MDR 2017/745 kuburikidza nenzira yeFull Quality Assurance — nzira iyo inoisa pasi pehurongwa hwekugadzira hwakazara hwemugadziri uye sisitimu yemhando yekugadzira pasi peNotified Body, pane kuongororwa kamwe chete kwerudzi rwechigadzirwa. Catheters dzinoiswa muzvikamu zveClass IIa zvishandiso zvekurapa pasi peMDR 2017/745, uye EU neEEA vanopinza havagone kuzviisa pamusika weEurope vasina CE mark inoshanda yakapihwa pasi pemutemo wakagadziridzwa.

Kune vanopinza zvinhu muEU vakagadzirisa nzira dzekutengesa kubva pakuchinja kweMDR, nzira yeFull Quality Assurance inoratidza kubatanidzwa kwakanyanya kwemugadziri nezvinodiwa nemutemo weEurope. Kudzora magadzirirwo, zvinyorwa zvekugadzirwa kwebatch, mishumo yekutarisa mushure memusika, uye package yemagwaro ehunyanzvi zvese zvinoongororwa uye zvinotariswa neCertificing Notified Body - hazviongororwe kamwe chete uye hazvina kugadzika.

Chitupa cheDAXAN cheCE MDR chinosanganisira mitsara yayo yezvigadzirwa zvecatheter inopfachukira nemvura. Sisitimu yemhando yepamusoro yeISO 13485:2016 inoenderana nehurongwa hwemagwaro ehunyanzvi nechimiro chinotarisirwa kupihwa nevanopinza zvinhu muEU panguva yekunyoreswa kwesimba renyika.

Kubvumidzwa kweDual FDA 510(k) K212567 neK243175: Kuwanikwa kweMusika weUS weHydrophilic neTPU Intermittent Catheters

DAXAN ine zvibvumirano zviviri zveFDA 510(k) zvakazvimiririra: K212567, inofukidza mutsetse wayo wecatheter unopfachukira nemvura, uye K243175, inofukidza TPU intermittent catheter series yayo. Nhamba dzese dzeK dzinogona kutsvakwa pachena mudhatabhesi reFDA 510(k), zvichipa vatengesi vekuUS magwaro ekuwana zvigadzirwa pamusika anogona kusimbiswa pachavo panguva yekuongorora kwemutengesi.

Chimiro chekubvisa zvinhu zviviri chinoratidza mitsetse miviri mikuru yeDAXAN. Vatengesi vekuUS vanotsvaga macatheter ePVC akajairika anonyungudika K212567; avo vanotsvaga TPU variant reference K243175 inoenderana nemuviri.

Pamwe chete nekubvumidzwa kwezvigadzirwa, DAXAN ine FDA Establishment Registration FEI 3023329815, inogona kutsvakwa kuburikidza neFDA's online facility registry. Kubvumidzwa kwe510(k) kwechigadzirwa pamwe nekunyoreswa kweFDA kwechikamu chefacility kunoumba chimiro chemagwaro ane zvikamu zviviri chinowanzo dikanwa nemapoka emitemo eUS ekutumira zvinhu kunze kwenyika vasati vapedza kupihwa kwemutengesi.

Kunyoresa uye Kutumira Magwaro kuNMPA: Zvitupa zveKutevedzera Mutemo weChina zveVabatsiri vekuAsia

Kunyoreswa kweNMPA (yaimbova CFDA) muChina kunosimbisa kuti zvigadzirwa zveDAXAN zvecatheter zvazadzisa ongororo yemutemo wemuno pasi pehurongwa hwezvigadzirwa zvekurapa hweChina — zvichisanganisira kuenderana kwemitemo yezvigadzirwa, kuongororwa kwemhando yesystem, uye zvinodiwa zvekutarisa mushure memusika. Kune vanotenga kunze kwenyika muAsia-Pacific vane maitiro ekunyoresa emuno anotsanangura mamiriro emutemo wenyika yekugadzira, kunyoreswa kweNMPA kunopa chiratidzo chekutevedzera mutemo kubva kwakabva.

DAXAN inewo Chitupa Chekutengesa Mahara (FSC) uye Chitupa Chekutanga cheCCPIT. FSC inonyora kodzero yekutumira kunze kwenyika kune misika iri kunze kweEU neUS regulatory frameworks — inowanzodiwa nevanopinza zvinhu muSoutheast Asia, Middle East, neLatin America pakunyorera mafomu ekupinda mumusika kana kunyoresa zvigadzirwa. Chitupa Chekutanga cheCCPIT chinoshanda mabasa ekunyora mitero yemutero mukutengeserana kwepasi rose, zvichisimbisa kwakabva kuChina kuti vaongorore mutero uye vatevedzere chibvumirano chekugovera.

Pamwe chete, kunyoreswa kweNMPA, FSC, uye chitupa cheCCPIT chepakutanga zvinopa vadyidzani mumisika iri kubuda gwaro rakazara, rinobva kune rimwe chete: kutevedzera kutevedzera kwechigadzirwa kubva kunyika inogadzira, kutenderwa kwekutumira kunze kwenyika, uye kusimbiswa kwekwakabva chigadzirwa.

ISO 13485:2016 Nzvimbo Yekuchenesa uye Kugona Kwegore Negore kwe20M: Nheyo Yekugadzira Inotsigira Kupihwa Chitupa Kwemisika Mitatu

Chitupa chega chega chekutonga chiri muchirongwa cheDAXAN chinobva pahwaro humwe chete hwekugadzira: imba yekugezera ine 6,000 m² yeISO 13485:2016 muChengdu, inotsigirwa nenzvimbo yekuyedza yakabatanidzwa uye inogadzira macatheter anodarika mamiriyoni makumi maviri anofema mvura pagore. Sisitimu yekutarisira mhando yeISO 13485:2016 haisi kungofanirwa kupihwa - asi inobatanidza masystem ese matatu ekutonga panguva imwe chete.

Magwaro ehunyanzvi eCE MDR, FDA's Quality System Regulation, uye zvinodiwa zvekuongorora zveNMPA zvese zvinobata ISO 13485 semusana wavo. Nekuti imwe QMS yakasimbiswa inotsigira kunyoreswa kwese kutatu, vanopinza havasi kuongorora mafomu matatu akafanana ekutevedzera mitemo - vari kuongorora nharaunda imwe chete yakanyorwa yekugadzira inogutsa vatongi vatatu, kuwedzera kushanda zvakanaka mukukodzera kwemutengesi.

Kukwanisa kwekugadzira kwe20M+ pagore kunoita kuti vanopinza zvinhu vawane kugadzikana kwezvekushandisa zvinodiwa pakugadzira zvibvumirano, mapurogiramu ekunyora mazita evanozviti maSKU, uye zvibvumirano zvekugovera zvinhu zvakasiyana-siyana.

Zvirongwa zveOEM Catheter zveVanotenga Zvinhu: FR Sizes CH06–CH24, Four Tip Configurations, uye Private Labeling

RUDYIChirongwa cheOEM chakagadzirirwa vanotenga kunze kwenyika vanotarisira mapotifoliyo emakatheta emudumbu akawanda eSKU. Kufukidza kwehukuru hweFrance kunosanganisira CH06 kusvika CH24, nehurefu uye magadzirirwo ematipi anotsanangurwa pamusika wakatarwa uye huwandu hwevarwere. Mhando ina dzematipi dziripo — Nelaton straight, Tiemann coude, ball, uye flexible — zvinoenderana nezvinodiwa zvekiriniki pamasero ese etsinga, BPH, urethral stricture, uye zviratidzo zve self-catheterization. Kusarudzwa kwezvinhu kunosanganisira PVC yemhando yekurapa uye DEHP-isina, BPA-isina TPU, ine label yakavanzika inogadziriswa zvichienderana nerudzi, mutauro, uye chikamu chekugovera.

Kuputira kwemvura kunoiswa paDAXAN's OEM intermittent catheter range ndiyo puratifomu yeCoatapex™ Hydrolyx™ — fomura yakavakirwa paPVP yakagadzirirwa kukweshana kwepasi uye kunyorova kwakagadzikana mushure mekushanda. Puratifomu yekuputira yeOEM inotsigirwa neDAXAN Patent Nos. ZL201610861058.4 uye ZL201811203221.3.

Mhuri dzezvigadzirwa zveOEM dziripo kune mapurogiramu epachivande ekunyora mazita dzinosanganisira hydrophilic Nelaton straight-tip catheter range, mutsetse wecatheter weDuro-Pocket® wakavharwa muRTU uye mumhando dzemvura dzinoshandiswa mu sachet, uye Katheta yeDuroFlex™ inochinjika-inopinza yeISC yekushandiswa kwemaumbirwo emuviri wemurume. Chigadzirwa chega chega chinogadzirwa mukati meDAXAN's ISO 13485 cleanroom uye chine zvitupa zveCE MDR, FDA 510(k), uye NMPA zvinoenderana nenzira yavanotengesera.

Kune vanotenga kunze kwenyika vanobatanidza kutevedzera mitemo, kugona kwekupa, uye kuchinjika kweOEM muhukama hwevatengesi veOEM catheter yekurapa, Chengdu Daxan Innovative Medical Tech Co., Ltd. inopa sarudzo yekugadzira yakanyorwa uye inoongororwa. Tsanangudzo dzezvigadzirwa, mapakeji emagwaro emutemo, uye ruzivo rwechirongwa cheOEM zvinowanikwa zvakananga kuburikidza www.daxanmedical.com.