Haina Kaihanga Kaituku OEM Catheter Hauora DAXAN: CE MDR, FDA 510(k), me te Rehitatanga NMPA mo nga Kaihokohoko.

Te whiriwhiri i tētahi mea pono Kaiwhakarato OEM Catheter Hauora mai i Haina ehara i te aromatawai noa i te utu waeine me te kaha whakaputa. Mō ngā kawemai o te ao, ko te paearu whakatau ko te kapinga ture: kei te pupuri tetahi kaihanga i te puranga hanganga ture — EU MDR 2017/745, US FDA 510(k), me Haina NMPA — e tutuki ana i te paepae tohu o ia mākete ūnga? He iti noa iho ngā kaihanga catheter o Haina ka taea te whakautu āe ki ngā mea e toru.

Nā DAXAN — te waitohu arumoni a Chengdu Daxan Innovative Medical Tech Co., Ltd., i whakatūria ki Chengdu i te tau 2016 — i hanga taua hoahoa ture. Mai i tētahi rūma ma kua whakamanahia e te ISO 13485:2016, he 6,000 m² te rahi, me tētahi pokapū whakamātautau whakauru, e whakaputa ana te kamupene i te neke atu i te 20 miriona catheters hydrophilic ia tau, ā, e kaweake ana ki neke atu i te 25 whenua, e mahi ana ki ngā kaituku, ki ngā kaipupuri waitohu, me ngā hoa OEM puta noa i Uropi, Amerika Te Raki, me te rohe o Āhia-Moana-nui-a-Kiwa.

E whakamārama ana tēnei pānui pāpāho i te anga ture taumata-toru kua whakatūria e DAXAN hei kaiwhakarato OEM mō ngā katitere hauora, te turanga hanga e tautoko ana i a ia, me te whānuitanga whakaritenga OEM e wātea ana ki ngā kawemai o te ao.

Kua Whakaūtia e DAXAN te Tiwhikete Ture Toru hei Kaiwhakarato OEM Catheter Hauora mō ngā Kawemai o te Ao

Kua whakaūtia e Chengdu Daxan Innovative Medical Tech Co., Ltd. te tiwhikete i te wā kotahi puta noa i ngā anga ture motuhake e toru: Te Tohu CE i raro i te EU MDR 2017/745 (Ara Whakaū Kounga Katoa), ngā whakaaetanga FDA 510(k) K212567 me K243175, me te rēhitatanga NMPA o Haina (ko CFDA o mua) — e tautokona ana e te pūnaha whakahaere kounga ISO 13485:2016. I te whakakotahitanga me te Rēhitatanga Whakatū FDA FEI 3023329815, ka whakanohoia e tēnei putea ture a DAXAN ki roto i tētahi rōpū iti o ngā kaihanga mimi o Haina ka taea te tautoko i te tohu kawemai mō ngā mākete o te EU, US, me Haina mai i te pūtake kotahi.

Ko ngā kaikawe mai o te ao e arotake ana i tētahi kaiwhakarato OEM catheter hauora, ko te tikanga ka whakatuwherahia ā rātou aromatawai i te taumata tiwhikete: Ka manatoko ngā kaihoko o te EU i te tutuki o te CE MDR me te ara motuhake o te Notified Body; Ka tono ngā kaihoko o Amerika i ngā nama-K 510(k) me te rēhitatanga o te whare; Ka whakaū ngā tīma hoko o Āhia-Moananui-a-Kiwa i te mana NMPA me ngā tuhinga kaweake.

Te Whakatutukitanga o te CE MDR 2017/745: Te Ara Whakapūmau Kounga Katoa mō ngā Kawemai Kātene Hauora o Ūropi

Kei a DAXAN te Tohu CE i raro i te EU MDR 2017/745 mā te ara Whakapūmau Kounga Katoa — te ara e tirotiro ana i te pūnaha whakawhanake hoahoa me te kounga whakaputa katoa a te kaihanga ki te tinana whakamōhio, kaua ki te tirotiro kotahi-wā i te momo hua. Ka whakarōpūtia ngā catheter wā-poto hei taputapu hauora Akomanga IIa i raro i te MDR 2017/745, ā, kāore e taea e ngā kawemai o te EU me te EEA te whakanoho i a rātou ki te mākete Pākehā me te kore he tohu CE whai mana i tukuna i raro i te ture whakahou.

Mō ngā kawemai o te EU kua whakahou i ngā mekameka tuku mai i te whakawhiti MDR, ko te ara Whakapūmau Kounga Katoa e tohu ana i te taumata teitei ake o te whai wāhi a te kaihanga ki ngā whakaritenga ture a te Pākehā. Ko ngā mana whakahaere hoahoa, ngā rekoata whakaputa puranga, te pūrongo tirotiro muri i te mākete, me te kete tuhinga hangarau ka arotakehia, ka aro turukihia hoki e te Rōpū Whakamōhiotanga whaimana — kāore i te aromatawaihia kotahi, ā, ka waiho kia tūmau.

Ko te tiwhikete CE MDR a DAXAN e kapi ana i ana raina hua catheter intermittent kua pania ki te wai. Ko te pūnaha kounga ISO 13485:2016 e hāngai ana i te hoahoa tuhinga hangarau ki te hanganga e tumanakohia ana e ngā kawemai o te EU ki te tuku i te wā rēhitatanga o te mana whakahaere ā-motu.

Ngā Whakaaetanga FDA 510(k) Takirua K212567 me K243175: Te Urunga ki te Mākete o Amerika mō ngā Catheters Hydrophilic me te TPU Intermittent

E rua ngā whakaaetanga motuhake a te FDA 510(k) a DAXAN: K212567, e kapi ana i tana raina catheter intermittent kua pania ki te hydrophilic, me K243175, e kapi ana i tana raupapa catheter intermittent TPU. Ka taea te rapu i ngā tau-K e rua i roto i te pātengi raraunga FDA 510(k), e hoatu ana ki ngā kawemai o US he tuhinga urunga hua taumata mākete ka taea te manatoko motuhake i te wā o te aromatawai kaiwhakarato.

Ko te hanganga āputa rua e whakaata ana i ngā raina rauemi matua e rua a DAXAN. Ko ngā kaiwhakarato o Amerika e hoko ana i ngā catheter PVC hydrophilic paerewa e tohutoro ana ki te K212567; ko te hunga e hoko ana i te momo TPU e rite ana ki te tinana e tohutoro ana ki te K243175.

Haunga ngā whakaaetanga hua, kei a DAXAN te Rēhitatanga Whakatū FDA FEI 3023329815, ka taea te rapu mā te rēhita whare ipurangi a te FDA. Ko te whakaaetanga taumata-hua 510(k) me te rēhitatanga FDA taumata-whare te hanganga tuhinga paparua e hiahiatia ana e ngā rōpū whakahaere take kawemai o US i mua i te whakaoti i te tohu kaiwhakarato.

Ngā tuhinga rēhitatanga me te kaweake NMPA: Ngā tohu whaimana mō Haina mō ngā hoa tohatoha Āhia

E whakaū ana te rēhitatanga NMPA o Haina (i mua ko CFDA) kua tutuki i ngā hua catheter a DAXAN te arotake ture ā-rohe i raro i te anga taputapu hauora o Haina — e kapi ana i te tutuki i ngā paerewa hua, te aromatawai pūnaha kounga, me ngā whakaritenga aroturuki muri-mākete. Mō ngā kawemai o Āhia-Moananui-a-Kiwa e tohu ana ā rātou tukanga rēhita ā-rohe i te mana ture o te whenua hanga, ka whakaratohia e te rēhitatanga NMPA he tohu tutuki ture kua whakaaetia mai i te pūtake.

Kei a DAXAN anō hoki te Tiwhikete Hoko Koreutu (FSC) me te Tiwhikete Taketake CCPIT. E whakaatu ana te FSC i te tika ki te kaweake mō ngā mākete i waho o ngā anga ture o te EU me te US — he mea e hiahiatia ana e ngā kaikawemai i te Tonga-mā-rāwhiti o Āhia, te Waenganui Rawhiti, me Amerika Latina ina tuku tono whakauru mākete, tono rēhita hua rānei. E mahi ana te Tiwhikete Taketake CCPIT i ngā mahi tuhi tikanga me ngā taripa i roto i te hokohoko whakawhiti-rohe, e whakaū ana i te takenga mai o Haina mō te aromatawai takoha me te tutuki i ngā whakaaetanga tohatoha.

Mā te rēhitatanga NMPA, te FSC, me te tiwhikete takenga mai o te CCPIT ka hoatu he kete tuhinga pūtake kotahi ki ngā hoa tohatoha puta noa i ngā mākete hou: te tutuki i ngā whakaritenga o te hua mai i te whenua hanga, te mana o te kaweake, me te manatoko takenga mai.

ISO 13485:2016 Whare Ma me te Kaha 20M ā-Tau: Ko te Tūāpapa Hanga i Muri i te Tiwhikete Mākete-Toru

Ko ia tiwhikete ture i roto i te putea a DAXAN e takoto ana i runga i te turanga hanga kotahi: he rūma horoi kua tiwhiketehia e te ISO 13485:2016 6,000 m² i Chengdu, e tautokona ana e te pokapū whakamātautau whakauru me te whakaputa i te neke atu i te 20 miriona catheters hydrophilic ia tau. Ehara te pūnaha whakahaere kounga ISO 13485:2016 i te tiwhikete whakaritenga noa iho - engari ko te hononga hanganga e hono ana i ngā anga ture e toru i te wā kotahi.

Ko ngā tuhinga hangarau CE MDR, ko te Ture Pūnaha Kounga a te FDA, me ngā paearu arotake a te NMPA e whakamahi ana i te ISO 13485 hei poutokomanawa hanganga. Nā te mea kotahi te QMS kua whakamanahia hei poutokomanawa mō ngā rēhitatanga e toru, kāore ngā kaikawemai e arotake ana i ngā hanganga ture ōrite e toru — kei te arotake rātou i tētahi taiao whakaputa kua tuhia kotahi e tutuki ana i ngā ture e toru, he hua whai hua nui tēnei i roto i te tohu a te kaiwhakarato.

Mā te kaha whakaputa ā-tau neke atu i te 20M ka whakawhiwhia ki ngā kawemai te pumau o te tuku e hiahiatia ana mō ngā kirimana anga, ngā kaupapa tapanga tūmataiti maha-SKU, me ngā whakaaetanga tohatoha taurangi-rahinga.

Ngā Kaupapa Kātene OEM mō ngā Kawemai: Ngā Rahi FR CH06–CH24, Ngā Whirihoranga Matawhā Whā, me te Tapanga Tūmataiti

MATAUKo te kaupapa OEM a te kamupene he mea hanga mō ngā kaikawemai e whakahaere ana i ngā putea catheter urology maha-SKU. Ko te whānuitanga o te kapi Wīwī e kapi ana i te CH06 ki te CH24, me ngā whirihoranga roa me te pito kua tautuhia mō ia mākete ūnga me te taupori tūroro. E whā ngā momo pito e wātea ana — Nelaton tika, Tiemann coude, pōro, me te ngāwari — e whakatutuki ana i ngā whakaritenga haumanu puta noa i te pūkahukahu neurogenic, BPH, urethral stricture, me ngā tohu paerewa mō te catheterization whaiaro. Ko te kōwhiringa rauemi e kapi ana i te PVC kounga hauora me te DEHP-kore, BPA-kore TPU, me te takai tapanga tūmataiti e taea te whakarite mā te waitohu, te reo, me te wae tohatoha.

Ko te paninga wai-whakaaro e whakamahia ana puta noa i te whānuitanga o ngā catheter OEM intermittent a DAXAN ko te tūāpapa Coatapex™ Hydrolyx™ motuhake — he hanganga PVP i hangaia mō te waku mata iti rawa me te hinu whakahinuhinu pumau i muri i te whakahohenga. E tautokona ana te tūāpapa paninga OEM e ngā Nama Patene DAXAN ZL201610861058.4 me ZL201811203221.3.

Ko ngā whānau hua OEM e wātea ana mō ngā kaupapa tapanga tūmataiti ko te hydrophilic Awhe catheter pito-tika a Nelaton, te raina catheter pūnaha-kati Duro-Pocket® i roto i ngā whakatakotoranga RTU me te whakahohenga putea wai, me te Te kātene ISC pito-ngawari a DuroFlex™ mō ngā tono hanganga tāne. Kei roto i te rūma ma ISO 13485 a DAXAN ia raina hua, ā, kei a ia ngā tiwhikete CE MDR, FDA 510(k), me te NMPA e tika ana mō tōna ara mākete.

Mō ngā kaikawemai e whakakotahi ana i te hanganga ture, te kaha tuku, me te ngāwari o te OEM ki roto i te hononga kaiwhakarato OEM kotahi o te catheter hauora, ka tukuna e Chengdu Daxan Innovative Medical Tech Co., Ltd. he kōwhiringa hanga kua tuhia me te taea te arotake. Kei te wātea tika ngā whakatakotoranga hua, ngā mōkihi tuhinga ture, me ngā taipitopito kaupapa OEM mā www.daxanmedical.com.