Ubushinwa Bwambere Bwambere Catheter OEM Utanga DAXAN: CE MDR, FDA 510 (k), no kwiyandikisha kwa NMPA kubatumiza mu mahanga

Guhitamo igikoresho cyizewe Umutanga serivisi ya OEM ya Catheter y'ubuvuzi Ese mu Bushinwa harimo ibirenze gusuzuma ikiguzi cy’imigabane n’ubushobozi bw’umusaruro. Ku batumiza ibicuruzwa mu mahanga, igipimo cy’ingenzi ni ukwishingira amategeko: ese uruganda rumwe rufite ibisabwa - EU MDR 2017/745, US FDA 510 (k), na China NMPA - byujuje ibisabwa ku isoko ryihariye? Ni bake cyane mu bakora catheter bo mu Bushinwa bashobora gusubiza yego kuri ibyo bitatu.

DAXAN — ikirango cy’ubucuruzi cya Chengdu Daxan Innovative Medical Tech Co., Ltd., cyashinzwe i Chengdu mu 2016 — cyubatse imiterere y’amategeko. Ikorera mu cyumba cy’isuku gifite uburebure bwa metero kare 6.000 gifite ikigo cy’ibizamini gihuriweho, ikigo gikora catheters zirenga miliyoni 20 zikoresha amazi buri mwaka kandi zohereza mu bihugu birenga 25, zigakorera abakwirakwiza ibicuruzwa, ba nyiri iki kigo, n’abafatanyabikorwa ba OEM hirya no hino mu Burayi, Amerika ya Ruguru, no mu karere ka Aziya na Pasifika.

Iri tangazo rigaragaza urwego rw’amategeko rw’ibice bitatu DAXAN yashyizeho nk’umucuruzi w’ibikoresho bya catheter by’ubuvuzi, ikigo cy’inganda kibishyigikira, hamwe n’uburyo bwo guhindura ibintu ku buryo bwa OEM bushobora gukoreshwa n’abatumiza ibicuruzwa mpuzamahanga.

DAXAN yemeje icyemezo cy’amategeko atatu nk’umucuruzi w’ibikoresho bya Catheter y’ubuvuzi ku bashoramari mpuzamahanga

Chengdu Daxan Innovative Medical Tech Co., Ltd. yemeje icyemezo cya rimwe mu nzego eshatu zigenga z’amategeko: CE Marking muri EU MDR 2017/745 (Full Quality Assurance pathway), FDA 510 (k) clearances K212567 na K243175, hamwe no kwiyandikisha muri China NMPA (yahoze ari CFDA) - byose bishingiye kuri sisitemu yo gucunga ubuziranenge ya ISO 13485:2016. Iyi poritifoliyo ihujwe na FDA Establishment Registration FEI 3023329815, ishyira DAXAN mu itsinda rito ry’inganda zikora urology zo mu Bushinwa zishobora gushyigikira impamyabushobozi z’abatumiza ibicuruzwa ku masoko y’imbere mu bihugu by’Uburayi, Amerika n’Ubushinwa ziturutse ahantu hamwe.

Abatumiza ibicuruzwa mpuzamahanga basuzuma umucuruzi wa catheter yo kwa muganga bakunze gufungura isuzuma ryabo ku rwego rw'icyemezo: Abaguzi bo mu Burayi bagenzura ko MDR yubahirizwa na CE n'inzira yihariye ya Notified Body; Abaguzi bo muri Amerika basaba nimero za 510 (k) K no kwiyandikisha ku kigo; Amatsinda ashinzwe gutanga amasoko muri Aziya na Pasifika yemeza aho NMPA iherereye n'inyandiko zo kohereza ibicuruzwa mu mahanga.

Iyubahirizwa rya CE MDR 2017/745: Inzira y'Ubuziranenge bwuzuye ku batumiza mu mahanga Catheter z'ubuvuzi zo mu Burayi

DAXAN ifite ikimenyetso cya CE muri EU MDR 2017/745 binyuze mu nzira ya Full Quality Assurance — inzira ishyira imbere igishushanyo mbonera cyuzuye cy’uruganda n’ubuziranenge bw’umusaruro ku igenzura rya Notified Body, aho gusuzuma ubwoko bw’ibicuruzwa inshuro imwe gusa. Catheters zishyirwa mu byiciro by’ibikoresho by’ubuvuzi bya Class IIa muri MDR 2017/745, kandi abatumiza ibicuruzwa muri EU na EEA ntibashobora kuzishyira ku isoko ry’i Burayi nta kimenyetso cya CE cyemewe cyatanzwe hakurikijwe amabwiriza mashya.

Ku batumiza ibicuruzwa mu mahanga bo mu Muryango w’Ubumwe bw’u Burayi bavuguruye imiyoboro y’ibicuruzwa kuva MDR yahinduka, inzira ya Full Quality Assurance igaragaza urwego rwo hejuru rw’ubufatanye bw’abakora ibicuruzwa n’ibisabwa n’amategeko y’Uburayi. Igenzura ry’imiterere y’ibicuruzwa, inyandiko z’ibicuruzwa byakozwe mu byiciro, raporo z’igenzura nyuma y’isoko, hamwe n’inyandiko z’ikoranabuhanga byose bisuzumwa kandi bigakurikiranwa n’Ikigo gishinzwe kwemeza ibicuruzwa - ntibisuzumwa rimwe ahubwo bigasigara bitameze neza.

Icyemezo cya DAXAN cya CE MDR gikubiyemo imirongo y’ibicuruzwa bya catheter ivanze n’amazi. Sisitemu y’ubuziranenge ya ISO 13485:2016 ihuza imiterere y’inyandiko za tekiniki n’imiterere abatumiza ibicuruzwa mu bihugu by’Ubumwe bw’u Burayi biteze gutanga mu gihe cyo kwandikisha ikigo cy’igihugu gishinzwe ubushobozi.

Inguzanyo ebyiri za FDA 510(k) K212567 na K243175: Uburyo bwo kubona isoko rya Amerika ku mashini zikoresha amazi n'amashanyarazi zikoresha TPU Intermittent Catheters

DAXAN ifite uburenganzira bubiri bwigenga bwa FDA 510 (k): K212567, ikubiyemo umurongo wayo wa catheter uhora utwikiriye amazi, na K243175, ikubiyemo urutonde rwayo rwa catheter ruhoraho rwa TPU. Imibare yombi ya K irashakishwa ku mugaragaro muri database ya FDA 510 (k), ibi bikaba biha abatumiza ibicuruzwa muri Amerika inyandiko zo ku rwego rw'isoko zishobora kwemezwa ku giti cyabo mu gihe cyo gusuzuma ibicuruzwa.

Imiterere y’ibikoresho bibiri igaragaza imirongo ibiri y’ingenzi ya DAXAN. Abacuruza ibikoresho muri Amerika bagura catheters za PVC zisanzwe zikoresha amazi K212567; abagura TPU ijyanye n’umubiri K243175.

Hamwe n'iyandikwa ry'ibicuruzwa, DAXAN ifite FDA Establishment Registration FEI 3023329815, ishobora gushakishwa binyuze mu bubiko bwa FDA kuri interineti. Iyandikwa ry'ibicuruzwa ku rwego rwa 510 (k) hamwe n'iyandikwa rya FDA ku rwego rw'ikigo bigize imiterere y'inyandiko y'urwego rubiri, amakipe y'abatumiza ibicuruzwa muri Amerika asanzwe asaba mbere yo kurangiza ibisabwa n'abatanga ibicuruzwa.

Kwandika no Kohereza mu mahanga inyandiko za NMPA: Impamyabumenyi z'Ubushinwa ku Bafatanyabikorwa bo mu Bushinwa bwo Gukwirakwiza ibicuruzwa muri Aziya

Kwandikisha kwa NMPA mu Bushinwa (cyahoze ari CFDA) byemeza ko ibicuruzwa bya catheter bya DAXAN byujuje isuzuma ry’amategeko agenga imikorere y’igihugu hakurikijwe urwego rw’ibikoresho by’ubuvuzi mu Bushinwa - bikubiyemo iyubahirizwa ry’amahame agenga imikorere y’ibicuruzwa, isuzuma ry’ubuziranenge bw’uburyo bikoreshwa, n’ibisabwa mu kugenzura nyuma y’isoko. Ku batumiza ibicuruzwa muri Aziya na Pasifika bafite inzira zo kwiyandikisha mu gihugu cyabo zigaragaza aho amategeko agenga imikorere y’igihugu gikora, kwandikisha kwa NMPA bitanga ikimenyetso cyemewe cy’uko amategeko yubahirizwa uhereye aho byaturutse.

DAXAN ifite kandi icyemezo cyo kugurisha ku buntu (FSC) n'icyemezo cya CCPIT cy'inkomoko. FSC igaragaza ko ibicuruzwa byoherezwa mu mahanga byujuje ibisabwa ku masoko atari mu rwego rw'amategeko agenga EU na Amerika - akunze gusabwa n'abatumiza ibicuruzwa mu majyepfo y'uburasirazuba bwa Aziya, mu Burasirazuba bwo Hagati, na Amerika y'Epfo mu gihe cyo gutanga ubusabe bwo kwinjira ku isoko cyangwa kwandikisha ibicuruzwa. Icyemezo cya CCPIT cy'inkomoko gitanga akazi ko kwandika ku misoro no ku misoro mu bucuruzi bwambukiranya imipaka, cyemeza ko inkomoko y'Ubushinwa ishingiye ku isuzuma ry'imisoro no kubahiriza amasezerano yo gukwirakwiza ibicuruzwa.

Hamwe na hamwe, kwiyandikisha kwa NMPA, FSC, n'icyemezo cy'umwimerere cya CCPIT biha abafatanyabikorwa mu gukwirakwiza ibicuruzwa mu masoko ari mu nzira y'amajyambere ipaki yuzuye y'inyandiko ituruka ahantu hamwe: kubahiriza amategeko y'ibicuruzwa mu gihugu gikora, uburenganzira bwo kohereza ibicuruzwa mu mahanga, no kugenzura inkomoko y'ibicuruzwa.

ISO 13485: 2016 Ikigo cy'Isuku n'Ubushobozi bwa Miliyoni 20 ku Mwaka: Ikigo cy'Inganda Gishinzwe Impamyabumenyi y'Isoko Ritatu

Buri cyemezo cy’amategeko agenga DAXAN gishingiye ku rufatiro rumwe rw’inganda: icyumba cy’isuku cyemewe na ISO 13485:2016 kiri i Chengdu gifite ubuso bwa metero kare 6.000, gishyigikiwe n’ikigo cy’ibizamini gihuriweho kandi gikora catheters zirenga miliyoni 20 zikoresha amazi ku mwaka. Sisitemu yo gucunga ubuziranenge ya ISO 13485:2016 si icyemezo cy’ibanze gusa - ni isano ry’imiterere rihuza inzego zose eshatu z’amategeko icyarimwe.

Inyandiko za tekiniki za CE MDR, amabwiriza agenga ubuziranenge bwa FDA, hamwe n'ibipimo ngenderwaho by'igenzura bya NMPA byose bifata ISO 13485 nk'inkingi y'imiterere yabyo. Kubera ko QMS imwe yemewe ari yo ishyigikira kwiyandikisha uko ari gatatu, abatumiza ibicuruzwa mu mahanga ntibasuzuma imiterere itatu ijyanye n'amategeko - barimo kugenzura imiterere imwe y'umusaruro yujuje ibisabwa ihuza abagenzuzi batatu, inyungu ifatika mu buvuzi bw'umutanga.

Ubushobozi bw'umusaruro bwa miliyoni 20+ buri mwaka buha abatumiza ibicuruzwa mu mahanga ubushobozi bwo gutanga ibicuruzwa buhamye bukenewe ku masezerano y'imiterere y'ibicuruzwa, gahunda z'ibirango byigenga bya SKU nyinshi, hamwe n'amasezerano yo gukwirakwiza ibicuruzwa mu buryo buhindagurika.

Porogaramu za OEM Catheter ku batumiza: Ingano za FR CH06–CH24, Imiterere y'ingingo enye, n'ibirango byihariye

IBURYOGahunda ya OEM yagenewe abatumiza ibicuruzwa mu mahanga bashinzwe gukoresha catheter nyinshi za SKU urology. Ubunini bw'igifaransa buri hagati ya CH06 na CH24, bufite imiterere y'uburebure n'agace k'inyongera bigenwa hakurikijwe isoko ryihariye n'umubare w'abarwayi. Hari ubwoko bune bw'agace k'inyongera buboneka - Nelaton straight, Tiemann coude, ball, na flexible - bujyanye n'ibikenewe mu buvuzi ku ruhago rw'imitsi, BPH, stricture y'inkari, n'ibimenyetso bisanzwe byo kwikemurira. Guhitamo ibikoresho bikubiyemo PVC yo mu rwego rw'ubuvuzi na DEHP, TPU idafite BPA, hamwe n'ibirango byihariye bihindurwa hakurikijwe ikirango, ururimi, n'ishami rikwirakwiza.

Igitambaro gitwikira amazi gishyirwa kuri catheter ya DAXAN ya OEM intermittent ni platform yihariye ya Coatapex™ Hydrolyx™ - formula ishingiye kuri PVP yagenewe gukururana ku buso buke cyane no gushonga neza nyuma yo gukoreshwa. Platform ya OEM ishyigikiwe na DAXAN Patent Nos. ZL201610861058.4 na ZL201811203221.3.

Imiryango y'ibicuruzwa bya OEM iboneka kuri gahunda z'ibirango byigenga irimo hydrophilic Uburyo bwa Nelaton bwo gupima katheta igororotse, umurongo wa catheter wa Duro-Pocket® ufunze mu buryo bwa RTU no mu buryo bwa sachet y'amazi, hamwe n'umuyoboro wa catheter Katheta ya DuroFlex™ ifite umutwe woroshye wa ISC ku bijyanye n'imikorere y'umubiri w'umugabo. Buri bwoko bw'ibicuruzwa bikorwa mu cyumba cy'ubuvuzi cya DAXAN cya ISO 13485 kandi gifite icyemezo cya CE MDR, FDA 510 (k), na NMPA bijyanye n'isoko ryayo.

Ku batumiza ibicuruzwa mu mahanga bahuza amategeko, ubushobozi bwo gutanga ibicuruzwa, n'uburyo bworoshye bwo gukora ibikoresho bya OEM mu mubano umwe n'umutanga serivisi za OEM za catheter y'ubuvuzi, Chengdu Daxan Innovative Medical Tech Co., Ltd. itanga uburyo bwo gukora ibikoresho bwanditse kandi bushobora kugenzurwa. Ibisobanuro by'ibicuruzwa, impapuro z'amabwiriza, n'ibisobanuro bya gahunda ya OEM biraboneka binyuze mu buryo butaziguye. www.daxanmedical.com.