Ko te kawemai i ngā whāriki here-whaiaro kua whakamanahia e te CE/FDA me mātua piri koe ki ngā anga ture motuhake. Mā tēnei hanganga ture ka whakarite koe i te haumaru o te hua, te whai huatanga, me te urunga ki te mākete. Kei roto i tēnei pou rangitaki he rārangi arowhai hanganga ture whānui mō ngā kaikawe mai i ngā whāriki here-whaiaro Orthodontic-passive.
Ngā Whakaaro Matua
- Me whai ngā kaikawemai i ngā ture tino pakari mō te CE me te FDA. Mā tēnei ka whakarite kia haumaru ngā taputapu hauora me te urunga atu ki te mākete.
- He mea nui ngā tiwhikete CE me te FDA. Ka taea te hoko i Ūropi me te US, ā, ka whakaatu hoki i te kounga o te hua.
- Tirohia tonu ngā tiwhikete a te kaihanga me ngā tapanga hua. Mā tēnei ka ārai i ngā raruraru, ā, ka pai te kawemai.
Te Mārama ki ngā Tiwhikete CE me te FDA mō ngā Pūmau Here-ā-Whaiaro Orthodontic
He aha te tohu CE mō ngā taputapu hauora?
Me mārama koe ki te tohu CE. Mā tēnei ka whakaū he taputapu hauora e tutuki ana i ngā paerewa hauora, haumaru, me te tiaki taiao o te Kotahitanga o Ūropi. Ka whakapirihia e ngā kaihanga te tohu CE. He mea whakahau tēnei tohu mō ngā hua e hokona ana i roto i te Rohe Ōhanga o Ūropi (EEA). He tohu tēnei e tutuki ana tō hua i ngā tohutohu me ngā ture katoa e pā ana ki te EU. Kei roto i tēnei ko teTe Ture mō ngā Pūrere Hauora (MDR)mō ngā taputapu pēnei i te Orthodontic Self Ligating Brackets-passive. E whakaatu ana koe i te tutuki i ngā whakaritenga matua mā te whai i tēnei tohu. Mā tēnei ka whakarite kia kore e nekenekehia tō hua i roto i te mākete kotahi o te EU.
He aha te Whakaaetanga, te Whakaaetanga rānei a te FDA mō ngā Pūrere Hauora?
Ko te Tari Kai me te Rongoā o Amerika (FDA) te kaiwhakahaere o ngā taputapu hauora i te Hononga o Amerika. Ka tūtaki koe ki te whakaaetanga 510(k) me te Whakaaetanga i mua i te Mākete (PMA). Ka pā te 510(k) ki ngā taputapu e rite ana ki ngā mea o nāianei. Ko te PMA mō ngā taputapu mōrearea nui ake. Mā ngā tukanga e rua ka whakarite kia haumaru, kia whai hua hoki tō taputapu mō tōna whakamahinga i te mākete o Amerika. Me whakatere koe i ēnei ara hei hokohoko ture i ō hua i te Hononga o Amerika. Mā tēnei aromatawai pakari ka tiakina te hauora tūmatanui.
He aha te Hiranga o ngā Tiwhikete e rua mō te Uru ki te Mākete o te Ao
Mā te whiwhi tiwhikete CE me te FDA ka huaki ngā whai wāhitanga mākete nui. Mā te tohu CE ka taea e koe te hoko atu i te mākete whānui o Ūropi. Mā te whakaaetanga FDA ka taea e koe te uru atu ki te Hononga o Amerika. He maha atu ngā whenua e whakaae ana, e tango ana rānei i ēnei paerewa pakari hei paearu mō ā rātou ake pūnaha ture. Mā te whiwhi tiwhikete e rua mō āu Orthodontic Self Ligating Brackets-passive e whakaatu he whakapau kaha ki tekounga ā-ao me te haumaru o te tūroro. Mā tēnei hanganga ture takirua ka whānui ake te horapa o tō mākete. Ka hanga hoki i te whakawhirinaki ki ngā tohunga hauora me ngā tūroro o te ao katoa, ka whakatū i tō hua hei kaiārahi.
Te Aroturukitanga Tika i mua i te Kawemai mō ngā Āwhata Here-Whaiaro
Te Manatoko i ngā Tiwhikete a te Kaihanga (Tohu CE, FDA 510(k) PMA rānei)
Me whakaū e koe ngā tiwhikete a te kaihanga. Tirohia tonutia mēnā he Tohu CE whai mana. Rapua te whakaaetanga FDA 510(k) te Whakaaetanga i mua i te Mākete (PMA) rānei. Mā ēnei tuhinga e whakaatu te tutuki o te hua. Tonoa ngā tiwhikete mana tika mai i te kaihanga. Me whakaū anō hoki e koe tōna pono. Mā tēnei taahiraa nui ka ārai i ngā take ture a meake nei. Ka whakarite kia tutuki i tō hua ngā paerewa haumaru nui.
Te Aromatawai i te Whakarōpūtanga Hua mō ngā Pūwero Niho
Me mārama koe ki te whakarōpūtanga o ngā hua.Ngā whāriki whakatikatika nihoKo te tikanga he Akomanga IIa i raro i ngā ture a te EU. Ko ngā taputapu Akomanga II ēnei mō te FDA. Ka tohua e tēnei whakarōpūtanga ngā whakaritenga ture motuhake. Mā te mōhio ki te akomanga tika ka āwhina i a koe ki te whakarite i ngā tuhinga tika. Ka pā hoki ki ngā whakamātautau e tika ana me ngā herenga muri i te mākete. Me whakaū wawe koe i tēnei whakarōpūtanga.
Te Mārama ki te Whakamahinga me ngā Whakaritenga Tapanga
Whakamāramahia mārama te whakamahinga e hiahiatia ana mō tengā whāriki here-whaiaro kore mahi. Mā tēnei whakamāramatanga e ārahi tō rautaki ture katoa. Me arotake e koe ngā whakaritenga tapanga katoa me te āta. Me whakauru ngā mōhiohio motuhake ki ngā tapanga. He maha ngā wā ka kapi i tēnei ngā taipitopito o te kaihanga, te ingoa o te taputapu, me ngā whakatūpato nui. Me whakarite kia tutuki ō tapanga i ngā ture CE me te FDA. Mā te tapanga hē ka arahi pea ki ngā whakaroa kawemai, ki te whakakorenga rānei.
Ngā Tohu Paetae me ngā Whakaaro Arotake mō te Kaiwhakarato
Me tino whai tohu koe i ō kaiwhakarato. Whakahaerehia ngā arotake o ā rātou whare hanga. Aromatawaihia ā rātou pūnaha whakahaere kounga (QMS). Manatokohia tō rātou piri ki ngā paerewa o te ao pēnei i te ISO 13485. Mā te QMS pakari ka pumau te kounga o te hua. He mea nui te whanaungatanga kaha ki ngā kaiwhakarato, i hangaia i runga i te whakawhirinaki me te tutuki i ngā whakaritenga, mō tō angitu. Mā tēnei mahi tirotiro tika ka whakaitihia ngā mōrearea, ā, ka tiakina hoki tō pakihi.
Te Rārangi Arowhai Whakatutukitanga CE mō ngā Kawemai o ngā Paepae Here-Whaiaro Paheko
Me whai huarahi hanganga te whakatere i te hanganga ture mō te CE. Me tutuki e koe ētahi herenga matua hei kawemai i ngā whāriki here-ā-unoa. Mā tēnei rārangi arowhai koe e ārahi i roto i ia taahiraa nui.
Te Whakatū i tētahi Māngai Whakamanatia
Me whakatū e koe tētahi Māngai Whakamana (AR) mēnā kei waho tō kaihanga i te Kotahitanga o Ūropi. Ko tēnei AR te pūwāhi whakapā a te kaihanga i roto i te EU. Mā rātou e whakarite kia tutuki ngā ture a te EU. Mā tō AR e whakahaere ngā whakawhitiwhiti kōrero me ngā mana whakahaere ā-motu. Ka āwhina hoki rātou i ngā mahi tirotiro i muri i te mākete. Kōwhiria he AR he tohunga ki ngā ture taputapu hauora. He mea nui tēnei kōwhiringa mō te urunga maeneene ki te mākete.
Tohutohu:Me puta te ingoa me te wāhitau o tō Māngai Whakamana ki te tapanga taputapu. Mā tēnei ka mārama te tautuhi i te rōpū kawenga i roto i te EU.
Te Whakapūmau i te Wātea o te Whakapuakitanga Whakatutukitanga (DoC)
Me whakarite kia wātea te Whakapuakitanga Whakatutukitanga (DoC). Ka tukuna tēnei tuhinga e te kaihanga. E kī ana kei te tutuki i ngā whāriki here-whaiaro korekore ngā whakaritenga hauora me te haumaru katoa e tika ana mō te EU. Ka whakaū te DoC i te tutuki ki ngā whakaritenga.Te Ture mō ngā Pūrere Hauora (MDR).Me whai kape koe o tēnei DoC. Ka taea e ngā mana whakahaere te tono i ngā wā katoa. Manatokohia kei te hou tonu te DoC, ā, kei te kapi hoki i tō hua.
Te Arotake i ngā Tuhinga Hangarau (Kōnae Hangarau)
Me arotake e koe te Tuhinga Hangarau a te kaihanga, e mōhiotia ana ko te Kōnae Hangarau. Kei roto i tēnei kōnae ngā kōrero taipitopito mō te taputapu. Kei roto ko ngā whakatakotoranga hoahoa, ngā aromatawai mōrearea, me ngā raraunga aromatawai haumanu. Ka whakamanahia e te Kōnae Hangarau te haumaru me te mahi a te taputapu. Kāore koe e hiahia ki te pupuri i te kōnae katoa. Heoi, me taea e koe te tuku atu ki ngā mana whakahaere ina tonoa. Kia mārama ki ngā ihirangi kia tika ai te tirotiro.
Ngā Whakaritenga mō te Tapanga me ngā Tohutohu mō te Whakamahinga (IFU)
Me whakarite kia tutuki ngā tapanga me ngā Tohutohu Whakamahi (IFU) i ngā whakaritenga CE. Me mārama, me mārama hoki ngā tapanga, me te reo o te whenua mema e hokona ana te taputapu. Me whakauru te tohu CE, te ingoa o te kaihanga, te wāhi noho, me ngā taipitopito a te AR. Ka whakaratohia e te IFU ngā mōhiohio nui mō te whakamahinga haumaru me te tika. Me whakaatu taipitopito i ngā tohu, ngā ārai, ngā whakatūpato, me ngā mahi whakatūpato. Mā te tapanga hē ka arahi pea ki te whakahokinga mai o ngā hua.
Anei ngā mea matua mō te tāpiri tapanga:
- Tohu CE:Mārama te kitea.
- Ngā Mōhiohio a te Kaihanga:Ingoa me te wāhitau.
- Māngai Whakamana:Ingoa me te wāhitau.
- Ingoa Pūrere:Te tautuhi mārama.
- Tau Puranga/Roto:Hei whai i te huarahi.
- Ngā Mōhiotanga mō te Whai Huakore:Mena e tika ana.
- Rā Paunga:Mena e tika ana.
- Te Tautuhi Pūrere Ahurei (UDI):E ai ki te whakaritenga a MDR.
Ngā Herenga Tirotiro i Muri i te Mākete (PMS)
He herenga tōu ki te Tirotiro i Muri i te Mākete (PMS) hei kawemai. Ko te tikanga me aroturuki e koe te mahi a te taputapu ina tae ki te mākete. Me ripoata e koe ngā aituā nui ki ngā mana whakahaere e tika ana. Ka whai wāhi atu hoki koe ki te ripoata i ngā au. Kei roto i tēnei ko te kohikohi me te arotake i ngā raraunga mō te mahi a te taputapu. Whakatūria he pūnaha hei whiwhi me te tukatuka i ngā amuamu. Mā tō whai wāhi kaha ki te PMS ka āwhina i te whakarite kia mau tonu te haumaru o te tūroro.
Te Rārangi Arowhai Tutukitanga FDA mō ngā Kawemai o ngā Pūmau Here-ā-Whaiaro Orthodontic-passive
Me āta tirotiro koe i ngā ture a te US Food and Drug Administration (FDA). Mā tēnei rārangi arowhai koe e ārahi i roto i ngā mahi nui mō te kawemai i ngā Orthodontic Self Ligating Brackets-passive ki te United States.
Te rēhita hei Kaihoko Mai ki te FDA
Me rēhita e koe tō whare ki te FDA. He taahiraa whakahau tēnei. Ka whakamahia e koe te Pūnaha Rēhitatanga me te Rārangi Whakakotahi a te FDA (FURLS) mō tēnei tukanga. Mā tēnei rēhitatanga koe e tohu hei kawemai mana o ngā taputapu hauora. Me whakahou e koe tēnei rēhitatanga i ia tau. Ki te kore e rēhita, ka roa pea te kawemai, ka whakakorehia rānei ō tuku.
Te Rārangi i ngā Pūrere ki te FDA
Me whakarārangi e koe ngā taputapu motuhake e hiahia ana koe ki te kawemai ki te FDA. He tukanga motuhake tēnei mai i tō rēhitatanga kawemai. Ka whakaratohia e koe ngā mōhiohio taipitopito mō ia momo taputapu. Kei roto i tēnei ko tōna whakarōpūtanga me te whakamahinga e hiahiatia ana. Mō ngā Orthodontic Self Ligating Brackets-passive, ka whakarārangihia e koe ngā tauira, ngā momo rānei motuhake e whakaaro ana koe ki te kawe mai ki te mākete o Amerika. Mā tēnei rārangi ka mōhio te FDA ki ngā taputapu e kawemai ana koe.
Te Whakarite i te Rēhitatanga o te Whare Hanga me te Rārangi Taputapu
Me manatoko e koe te tutuki a tō kaihanga. Me rēhita hoki e te kaihanga o tāwāhi o tō Orthodontic Self Ligating Brackets-passive tā rātou whare ki te FDA. Me whakarārangi e rātou ā rātou taputapu. Kāore e taea e koe te kawemai i ngā taputapu mai i tētahi kaihanga kāore i rēhitatia, kāore rānei i te rārangihia. Tonoa he taunakitanga mō tā rātou rēhitatanga me te rārangi o nāianei. He mea nui tēnei taahiraa mō tō tutuki i a koe anō.
Te Mārama ki te Whakatutuki i ngā Ture Whakahaere Pūnaha Kounga (QSR) (21 CFR Wāhanga 820)
Me mārama koe ki te Ture Pūnaha Kounga (QSR). Kei roto i tēnei ture te 21 CFR Wāhanga 820. Mā tēnei ka whakarite kia haumaru ngā taputapu hauora. Ka whakarite hoki kia whai hua. Ka hipokina e te QSR ngā tikanga, ngā whakaurunga, me ngā mana whakahaere e whakamahia ana mō te hoahoa, te hanga, te tākai, te tapanga, te penapena, te tāuta, me te mahi ratonga i ngā taputapu hauora. Kei a koe te kawenga mō te whakarite kia tutuki i tō kaihanga o tāwāhi te QSR. Kei roto i tēnei:
- Ngā Mana Hoahoa:Te whakarite kia tutuki i te hoahoa o te taputapu ngā hiahia o te kaiwhakamahi.
- Ngā Mana Whakahaere Whakaputa me te Tukanga:Te pupuri i te kounga hanga rite tonu.
- Ngā Mahi Whakatikatika me te Ārai (CAPA):Te aro atu me te aukati i ngā take kounga.
- Te Kawenga Whakahaere:Te whakarite kia tautokona te pūnaha kounga e te whakahaere matua.
Tuhipoka:Ahakoa e whakatinana tika ana te kaihanga i te QSR, ko koe, hei kawemai, te kawenga mō te whakarite kia tutuki ā rātou whakaritenga. Me whakahaere e koe he arotake, me tono rānei i ngā tuhinga hei whakaū i tā rātou tutuki.
Ngā Whakaritenga Tapanga (21 CFR Wāhanga 801)
Me whai koe i ngā whakaritenga tapanga tino pakari a te FDA. Kei roto i te 21 CFR Wāhanga 801 ēnei e whakamāramahia ana. Me whai mōhiohio motuhake ngā tapanga. Me reo Ingarihi. Kia mōhio kei roto i ō tapanga:
- Te ingoa me te wāhitau o te kaihanga.
- Te ingoa o te taputapu.
- Te whakamahinga i whakaarohia.
- Ngā whakatūpato, ngā mahi ārai rānei e tika ana.
- Te Tautuhi Pūrere Ahurei (UDI).
- Ngā tohutohu mō te whakamahi.
Mā te tapanga hē, kāore rānei i oti te tapanga ka puritia pea ō taputapu ki te rohe.
Ngā Herenga Pūrongo Pūrere Hauora (MDR)
He herenga tāu mō te Pūrongo Pūrere Hauora (MDR). Me pūrongo e koe ētahi pānga kino ki te FDA. Kei roto i tēnei ko:
- Ngā matenga e pā ana ki te taputapu.
- Ngā whara kino e pā ana ki te taputapu.
- Ngā hapa o te taputapu mēnā ka puta anō, ka mate pea, ka whara kino rānei.
Me whakatū e koe he pūnaha hei kohikohi me te tuku i ēnei pūrongo. Mā tēnei ka āta aroturukihia e te FDA te haumaru o ngā taputapu.
Ngā Tukanga Whakauru Kawemai me te Whakawātea Tikanga
Me whai koe i ngā tikanga whakauru kawemai me ngā tikanga whakawātea tikanga. He mahi tā te FDA ki te whakawātea i ngā taputapu hauora i te rohe o Amerika. Me whakarato e koe ngā tuhinga tika. Kei roto i tēnei ko te pānui taenga mai i mua. Me tuku hoki e koe ngā puka whakauru. Tērā pea ka tirotirohia e te FDA ō uta. Tērā pea ka puritia e rātou ngā taputapu mēnā e whakapae ana rātou kāore i te tutuki i ngā whakaritenga. Mahi tahi me tō kaihoko tikanga. Me whakarite kia tika, kia oti hoki ngā pepa katoa e tika ana. Mā tēnei ka ārai i ngā whakaroa.
Ngā Mahanga Noa i te Kawemai i ngā Ārai Here-Whaiaro, me pēhea te karo i aua Mahanga
He maha ngā wero e pā ana ki a koe i te wā e kawemai ana i ngā taputapu hauora. Mā te mārama ki ēnei hapa ka āwhina i a koe ki te karo i ngā hapa utu nui. Ka taea e koe te whakarite kia maeneene ake, kia tutuki hoki ngā whakaritenga o te tukanga kawemai.
Ngā tuhinga kāore i oti
He maha ngā wā ka pāngia koe e ngā whakaroa nā te ngaro, te kore rānei o ngā tuhinga i oti. Kei roto i tēnei ko Tiwhikete CE, whakaaetanga FDAngā reta, ngā kōnae hangarau rānei. Ka whakamutua e ngā āpiha tikanga tō tuku me te kore he pepa tika. Me tino manatoko e koe ngā tuhinga katoa e hiahiatia ana i mua i te tukunga o ō hua.
Te Whakamāoritanga Hē o ngā Ture
Tērā pea ka hē te whakamārama i ngā ture uaua o te CE, o te FDA rānei. He maha ngā wā ka huri ēnei ture. Ka taea e te hē te arahi ki te kore e tutuki i ngā whakaritenga. Ka hua ake tēnei i ngā whakahokinga mai o ngā hua, i ngā aukati mākete rānei. Me kōrero koe ki ngā tohunga ture, me arotake tonu rānei i ngā aratohu mana.
Te Kore o te Pūnaha Mataara i Muri i te Mākete
Ka tūpono koe ki ngā whiu nui mēnā kāore he pūnaha mataaratanga pakari i muri i te hoko. Me aroturuki koe i te mahi a te taputapu i muri i te hoko. Ki te kore e ripoata i ngā āhuatanga kino, i ngā ia rānei, ka takahi i ngā ture. Whakatūria he tikanga mārama mō te whakahaere amuamu me te ripoata i ngā aituā.
Tapanga Kore-Ture, IFU rānei
Ka taea e koe te whakahē mēnā kāore tō tapanga, tō Tohutohu Whakamahi rānei (IFU) e tutuki i ngā paerewa. Me whai kōrero motuhake ngā tapanga i roto i te reo tika. Me whakauru hoki ngā tohu e hiahiatia ana. Ki te hē te tapanga, ka āraia koe e te ture tāke. Me arotake marie e koe ngā tapanga katoa kia rite ki ngā whakaritenga CE me te FDA.
Te Kōwhiri i ngā Kaihanga Kāore i te Pono
Ka whakararu koe i tō mahi katoa mā te mahi tahi me ngā kaihanga pono kore. Kāore i ētahi kaihanga he pūnaha whakahaere kounga tika, he tiwhikete rānei. Ka hua ake tēnei i ngā hua kounga iti. Me whakahaere e koe he tirotiro tika me ngā arotake i ngā kaiwhakarato katoa.
Ngā Tikanga Pai mō te Whakatutuki Tonu i ngā Ture Whakapiri-ā-Whaiaro Orthodontic
Me pupuri e koete tutuki tonu i ngā whakaritenga.Mā tēnei ka noho tonu ō Orthodontic Self Ligating Brackets-passive kawemai ki te mākete. Mā ngā mahi matatau ka ārai i ngā take ture a meake nei.
Arotake Auau o ngā Whakahōutanga Ture
Me noho mōhio tonu koe ki ngā huringa ture. Ka whanake haere ngā ture CE me te FDA. Tirohia ngā pānuitanga FDA me ngā whakahoutanga ture o te EU i ia wā. Ohauru ki ngā pānui ahumahi. Mā tēnei ka āwhina i a koe ki te whakarerekē wawe i ō tukanga.
Te Pupuri i ngā Rekoata Whānui
Me pupuri e koe ngā tuhinga tino tika. Tuhia ngā āhuatanga katoa o tō tukanga kawemai. Kei roto i tēnei ko ngā whakaaetanga a ngā kaiwhakarato, ngā whakapuakitanga kawemai, ngā arowhai whakahaere kounga, me ngā rārangi amuamu. He mea nui ēnei tuhinga mō ngā arotake. E whakaatu ana i tō piripono ki ngā ture.
Te Whakatū i ngā Tukanga Whakatutuki ā-Roto
Me whakawhanake e koe ngā tikanga hanganga ture ā-roto mārama. Waihangahia ngā Tikanga Whakahaere Paerewa (SOP) mō ia taahiraa. Ka hipokina e tēnei te whiwhinga, te rokiroki, me te tohatoha. Mā ngā tikanga ōrite ka whakaitihia ngā hapa. Ka whakarite kia whai ngā kaimahi katoa i ngā aratohu ture.
Te Whakangungu i ngā Kaimahi mō ngā Whakaritenga Ture
Me whakangungu koe i ō kaimahi kia tino mārama. Whakaakona rātou ki ngā whakaritenga katoa e pā ana ki te CE me te FDA. Kei roto i tēnei ko te tapanga, te ripoata i ngā pānga kino, me te whakahaere kounga. Mā ngā kaimahi kua tino whakangungua ka ārai i te kore tutuki i ngā whakaritenga. E mārama ana rātou ki te hiranga o te whakahaere tika i ngā Brackets Orthodontic Self Ligating Brackets-passive.
Te Whakauru i ngā Kaitohutohu Ture ina hiahiatia
Me whakaaro koe ki te whakamahi i ngā kaitohutohu ture. Ka tukuna e rātou he aratohu tohunga mō ngā take uaua. Ka taea e ngā kaitohutohu te āwhina ki te whakamārama i ngā ture hou. Ka āwhina hoki rātou ki te whakarite arotake. Mā ō rātou tohungatanga ka mau tonu te pakari o tō rautaki hanganga ture.
He mea nui te whakatere i ngā uauatanga o te hanganga ture CE me te FDA mō ngā whāriki here-whaiaro kore mahi mō te kawemai angitu. Mā te whai māia i tēnei rārangi arowhai whānui, ka taea e koe te whakaiti i ngā mōrearea ka pā mai. Ka whakarite koe i te urunga pai ki te mākete. Ka pupuri hoki koe i ngā paerewa haumaru tūroro teitei rawa atu.
Ngā Pātai Auau
He aha te taahiraa tuatahi me mahi e koe hei kaihoko mai?
Me manatoko e koe ngā tiwhikete CE me te FDA a te kaihanga. Mā tēnei ka whakarite kia tutukihia ngā whakaritenga o te hua mai i te tīmatanga.
Me whiwhi tonu koe i ngā tiwhikete CE me te FDA?
Ae, me rua ngā mea e hiahiatia ana mō te urunga atu ki te mākete o te ao. Mā te CE ka taea te hoko i Ūropi, ā, mā te FDA ka taea te hoko i te US.
Ka aha mēnā kāore ō tuhinga i oti?
Ka whakaroa, ka whakakore rānei ngā āpiha tikanga i tō tuku. Me whakarite kia oti katoa ngā tuhinga i mua i te tuku.
Wā tuku: Whiringa-ā-rangi 11-2025