He aha te Hiranga o ngā Tiwhikete CE, FDA, me ISO mō ngā Kaiwhakarato Niho

Kupu Whakataki

Mō ngā kaiwhakarato niho, ko te tohu CE, te whakaaetanga FDA, me te tiwhikete ISO he tohu whai hua hei whakaatu mēnā ka taea te hoko, te whakawhirinaki, me te whakamahi haumaru i tētahi hua i roto i ngā wāhi haumanu. Mā ēnei paerewa ka hangaia te urunga ki te mākete i Ūropi, te Hononga o Amerika, me ētahi atu rohe whakahaere, me te hoatu hoki i ngā taunakitanga mārama ake ki ngā kaihoko mō te mana whakahaere hanga, te mahi hua, me te tutuki i ngā ture. Mā te mārama ki te tohu o ia tiwhikete ka āwhina i ngā kaiwhakarato ki te whakaiti i te mōrearea ture me te arumoni, te whakapakari i te mana hoko, me te whakataetae pai ake ki ngā kaihanga whai tohu. E whakamārama ana ngā wāhanga i raro nei me pēhea te awe o ēnei tohu ki te whakapono o te kaihoko, te tohatoha whakawhiti-rohe, me te pumau mō te wā roa o tētahi pakihi tuku niho.

He aha te Hiranga o ngā Tiwhikete CE, FDA, me ISO mō ngā Kaiwhakarato Niho

Kei raro i ngā anga ture pakari te mākete taputapu niho o te ao, nā te mea he pānga tika ēnei hua ki tete haumaru o te tūroroKi ngā kaiwhakarato niho, ehara i te mea he tikanga whakahaere noa iho te whiwhi tohu CE, te whakaaetanga FDA, me ngā tiwhikete ISO, engari he whakaritenga matua mō te whai huatanga arumoni. Ka mahi ēnei tohu hei paerewa mō te kounga, te whai huatanga, me te haumaru, e whakatau ana i te kaha o te kaiwhakarato ki te tohatoha i ngā taputapu hauora puta noa i ngā mākete matua o te ao.

Te whakaiti i te mōrearea me te whakawhirinaki o te kaihoko

He nui te kawenga mō ngā tohunga hoko me ngā kaiwhakahaere haumanu ina rapu ana i ngā taputapu niho me ngā taputapu whakapaipai. Mā te whakamahi i ngā hua kāore i whakamanahia ka nui ake te tūponotanga o ngā aituā haumanu kino, ka hua ake he kino nui ki te taha pūtea me te ingoa pai. Mā te whakauru atu ki ngā kaiwhakarato he tohu whakamanahia, ka whakaitihia e ngā kaihoko ēnei mōrearea. E whakaatu ana ngā tātaritanga tatauranga o te tirotiro i muri i te mākete kei te pupuri tonu ngā whare kua whakamanahia e te ISO 13485 i ngā reiti hapa i raro i te 0.5%, ki te whakaritea ki ngā hinonga kāore i whakamanahia, ka taea e te rerekētanga te neke ake i te 3% ki te 5%. Mā tēnei pono ā-wheako ka whakatairanga i te whakawhirinaki a ngā kaihoko mō te wā roa, ā, ka whakau i ngā mahi mekameka tuku.

Te urunga ki te mākete me ngā tumanakohanga tutuki i ngā ture

Ko ngā tiwhikete te take e hiahiatia ai te urunga ki te mākete ā-whenua. E hiahiatia ana e te United States te whakaaetanga FDA (ko te tikanga he 510(k) mō ngā taputapu Akomanga II), ko te Kotahitanga o Europi ia e whakahau ana i te tohu CE i raro i te Ture Pūrere Hauora pakari (MDR 2017/745). Ki te kore ēnei whakaaetanga, ka āraia turetia ngā kaiwhakarato niho ki te hokohoko i ā rātou hua i roto i ēnei rohe whai hua. Hei tauira, ko te kore e tutuki i te EU MDR ka hua ake he aukati tonu i te mākete puta noa i ngā whenua mema 27, ka tapahia te uara o te mākete neke atu i te €15 piriona ia tau. Nō reira, e tumanako ana ngā tīma hoko kia mau tonu ngā kaiwhakarato ki te tutuki i ngā whakaritenga kia kore ai e puta he raruraru ohorere i roto i te mekameka tuku nā ngā mahi whakamana ture.

Te Tikanga o ngā Tiwhikete CE, FDA, me ISO

Ko te whakatere i te taiao ture me mārama ki te tikanga o ia tohu. Ahakoa he maha ngā wā ka huihuia ngātahitia, ko te tohu CE, te whakaaetanga FDA, me te tiwhikete ISO he mahi ture me te mahi motuhake i roto i te pūnaha hanga niho.

Te tohu CE me te whakaaetanga FDA me te tiwhikete ISO

Ko te tiwhikete ISO, inā koa ko te ISO 13485, e whakahaere ana i te Pūnaha Whakahaere Kounga (QMS) o tētahi kaihanga taputapu hauora, e whakarite ana i te hoahoa, te whakawhanake, me ngā tukanga whakaputa ōrite. I tetahi atu taha, ko te whakaaetanga FDA me te tohu CE he whakaaetanga mākete motuhake ki te hua.

Ngā ara whakarōpūtanga hua me te tiwhikete

Ka whakarōpūtia ngā taputapu niho e te mōrearea, ā, koinei te ara whakamana. Ka whakarōpūtia e te FDA ngā taputapu ki te Akomanga I (mōrearea iti, hei tauira, ngā paraihe niho ā-ringa), te Akomanga II (mōrearea waenga, hei tauira, te ranunga niho, ngā rama whakamaroke), me te Akomanga III (mōrearea nui, hei tauira, ngā rauemi honohono wheua). Ko te taputapu Akomanga II noa me whai whakamōhiotanga 510(k) i mua i te mākete, e whakaatu ana i te ōritetanga nui ki tētahi taputapu matua e hokohokohia ana e te ture, ā, e 90 ki te 180 ngā rā e hiahiatia ana mō te whakaaetanga. I raro i te EU MDR, ka kapi ngā whakarōpūtanga i te Akomanga I, IIa, IIb, me te III. Ko te ara mō tētahi taputapu Akomanga IIa, teitei ake rānei, me whai aromatawai hanganga ture e tētahi Tinana Whakamōhiotia, he tukanga pakari ka taea te roa mō te 12 ki te 24 marama, ā, me whai taunakitanga haumanu whānui.

Ngā rerekētanga o te whānuitanga me te tuhinga

He rerekē rawa te kawenga tuhinga i waenga i ēnei anga. E hiahiatia ana e te ISO 13485 ngā pukapuka ā-ringa QMS whānui, ngā tuhinga arotake ā-roto, me ngā kawa arotake whakahaere. Me whai Rekoata Matua Pūrere (DMR) me te Kōnae Hītori Hoahoa (DHF) ngā tuku a te FDA. Ko te tohu CE i raro i te MDR e whakauru ana i ngā whakaritenga whānui ake, tae atu ki te Whai Aroturuki Haumanu Muri-Mākete (PMCF) me ngā Pūrongo Whakahōu Haumaru Ā-Wā (PSUR). Me whakarite e ngā kaiwhakarato he rauemi nui hei pupuri i ēnei kōnae hangarau; ki te kore he arotake, ki te kore rānei he pūrongo aromatawai haumanu kotahi e hiahiatia ana, ka mutu tonu te mana hokohoko.

Te Pānga o ngā Tiwhikete ki te Kounga o te Kaiwhakarato

Haunga te whai i ngā ture, ko te whai me te pupuri i ēnei tiwhikete ka tino huri i te hanganga whakahaere a te kaiwhakarato. Ko ngā kaiwhakarato niho whaimana e whakaatu ana i te whakahaere hanga kua whakarei ake, e whai hua tika ana ki te hua pai.kounga me te ponomō te kaiwhakamahi mutunga.

Te whai i te aru me te whakahaere kounga

Ko tētahi o ngā tūāpapa o te ISO 13485 me te FDA 21 CFR Wāhanga 820 ko te whai i ngā hua katoa mai i te tīmatanga ki te mutunga. Ka whakatinanahia e ngā kaiwhakarato whaimana ngā pūnaha whai-rōpū pakari me ngā tikanga Tautuhi Pūrere Ahurei (UDI). Mā tēnei ka taea te whai i ngā hua katoa o ngā taputapu niho, o ngā rauemi koiora rānei, tae atu ki te puranga rauemi mata me te huringa hanga motuhake. I roto i ngā kupu mahi, mēnā ka kitea he puranga hapa o ngā mea hanga niho, ka taea e te kaiwhakarato whaimana te whakahaere i tētahi whakahokinga kua whakaritea i roto i ngā haora 24 ki te 48, ka wehea te puranga 500-wāhanga tika, kaua ki te whakahoki noa i ngā tekau mano o ngā waeine. Mā tēnei ka whakaitihia te ohorere o te mekameka tuku.

Ngā taupatupatu tere, utu, me te tutuki i ngā whakaritenga

Ko te whakatutuki i tēnei taumata o te mana whakahaere kounga ka puta he taupatupatu e tika ana i waenga i te tere, te utu, me te tutuki i ngā whakaritenga. Ko te whakatinana i tētahi QMS e tutuki ana i ngā whakaritenga me te whiwhi tiwhikete ISO 13485 tuatahi me whai haumitanga mai i te $20,000 ki te $50,000. Kāore i roto i tēnei ko ngā utu arotake ā-tau, ngā utu motuhake rānei mō ngā rēhitatanga hua FDA me CE, e taea ai te neke atu i te $100,000 mō ngā taputapu uaua o te Akomanga IIb, III rānei. Nō reira, he maha ngā kaiwhakarato kua whai tiwhikete he nui ake ngā Rahinga Ota Iti rawa (MOQ) me ngā utu waeine ki ngā kaiwhakataetae mākete hina kāore i whai tiwhikete. Heoi, ka whakakorengia e ngā kaihoko ēnei utu tuatahi mā te karo i ngā utu huna o ngā reiti hapa nui, ngā whakakorenga tuku i ngā tari taake, me ngā nama mahi hē pea.

Ngā paearu matua mō te aromatawai a te kaihoko

I te aromatawai i ngā kaiwhakarato niho pea, me titiro ngā tīma hoko ki tua atu i te aroaro noa o tētahi tiwhikete. Me uru atu ki ngā paearu aromatawai matua te pakari o te pūnaha Whakatikatika me te Ārai (CAPA) a te kaiwhakarato, ō rātou wā urupare hītori ki ngā korenga o te kounga, me ō rātou auau arotake ā-roto. Ko te kaiwhakarato e whakamahi kaha ana i tana pūnaha CAPA hei akiaki i te whakapai tonu—e whakaatuhia ana e te whakaiti i ngā amuamu a te kiritaki i roto i te wā 12-marama—e whakaatu ana i tētahi ahurea kounga pakari e hipa ana i ngā whakaritenga ture taketake.

Me pēhea te manatoko a ngā kaihoko i ngā kereme tiwhikete

Ko te horapa o ngā tiwhikete tinihanga, kua pau rānei te wā i roto i te rāngai hangahanga o te ao, me tino tirotirohia. Kāore e taea e ngā tohunga hokohoko te whakaae i ngā tuhinga noa iho; he mea nui te manatoko pakari hei tiaki i te pono o te mekameka tuku niho.

Ngā tuhinga hei tono mai i ngā kaiwhakarato

Me whakauru te whakaurunga tuatahi ki te kaiwhakarato i tētahi tono whaimana mō ngā tuhinga ture motuhake. Me tono ngā kaihoko i te tiwhikete ISO 13485 o nāianei, te Whakapuakitanga Whakaritenga a te EU (DoC), te Rēhitatanga Whakatūnga FDA, me te reta whakaaetanga 510(k) motuhake mō ngā taputapu ūnga. Hei tāpiri, mā te tono i te pūrongo whakarāpopototanga hou mai i tētahi arotake a te Rōpū Whakamōhiotia, i tētahi Pūrongo Tirotiro Whakatūnga FDA (EIR) rānei, ka kitea he māramatanga hohonu ki te tūnga tutuki tonu o te kaiwhakarato me ngā kore tutukitanga hou.

Me pēhea te whakamana i te rēhitatanga me ngā tiwhikete

Kāore e ranea te pupuri noa i tētahi tuhinga; me whakamana motuhake tōna pono mā roto i ngā huarahi mana.

Me hono ngā kaihoko i te ingoa tuturu o te hinonga pakihi me te wāhitau o te whare hanga kei runga i te tiwhikete ki te pātengi raraunga mana. Ko ngā rerekētanga—pērā i te tiwhikete i tukuna ki tētahi kamupene matua engari ehara i te apiti motuhake e hanga ana i ngā tūru niho—he tohu nui tēnei mō te tutuki i ngā whakaritenga.

He tukanga tirotiro tika whai hua

Me whai i tētahi huarahi mahi tirotiro tika whaihua i tētahi huarahi hanganga, maha-taumata. Tuatahi, whakahaerehia he manatoko mamati tuatahi ki ngā pātengi raraunga tūmatanui. I te nuinga o te wā, he iti iho i te 48 hāora te roa o tēnei engari ka taea te tātari tonu i ngā kaihoko tinihanga. Tuarua, manatokohia te whānuitanga; kia tino kapi te tiwhikete ISO 13485 i "ngā taputapu niho"ranei" ngā rauemi whakatikatika niho "kaua ko te hanga konganuku whānui. Hei whakamutunga, me whakahau kia arotakehia e te hunga tuatoru i te wāhi mahi i mua i te whakaoti i tētahi kirimana e neke atu ana i tētahi paepae pūtea kua tautuhia i mua, pērā i te $50,000 i roto i te whakapaunga ā-tau. Mā tēnei manatoko ā-tinana e whakaū kei te whakamahia tonutia te QMS kua whakaahuatia i roto i ngā tuhinga i runga i te papa wheketere.

Me pēhea te whakatau pai ake mō te tiwhikete me te rapu rauemi

Ko te arotau i te mekameka tuku niho me whai hononga rautaki i waenga i ngā kōtaha mōrearea hua, ngā whakaritenga ture, me ngā whāinga hoko. Me whakawhanake e ngā kaihoko he anga rauemi e whakamahi ana i ngā tiwhikete hei taputapu waihanga uara, kaua e titiro noa ki ēnei hei arai whakahaere.

Te whakatairanga i ngā haumitanga tiwhikete

Me whakarite e ngā whakahaere ngā whakaritenga tiwhikete i runga i te whakarōpūtanga o ngā taputapu me te whakamahinga haumanu e whakaarohia ana. Mō ngā taputapu kore-parakore o te Akomanga I, pērā i ngā whakaata whakamātautau taketake, mā te tohe kia whiwhi tiwhikete CE MDR uaua mai i tētahi Rōpū Whakamōhio taumata-runga ka piki ake pea ngā utu. I tetahi atu taha, mō ngā taputapu whakauru Akomanga III, kāore e taea te whiriwhiri i te whakaiti i ngā tohu FDA, CE rānei. Me whakahau ngā tīma hoko i te ISO 13485 hei paerewa tūāpapa mō te 100% o ā rātou kaiwhakarato matua, me te whakarite kia whai taumata taketake owhakahaere koungaputa noa i te pūnaha kaihoko katoa i mua i te aromatawai i ngā whakamanatanga motuhake ki te hua.

Te whakataurite i te tutuki i ngā whakaritenga, te utu, me te mōrearea tuku

Ko te whakataurite i te tutuki i ngā whakaritenga, te utu, me te mōrearea tuku ko te whakamahi i tētahi rautaki putea kaiwhakarato taumata-papa. Mā te whakawhirinaki ki tētahi kaiwhakarato kotahi, he tino whaimana i roto i tētahi mana whakahaere utu nui ka whakaiti i te mōrearea tutuki i ngā whakaritenga engari ka whakanui ake i te utu me te ngoikore ki ngā whakararuraru ā-rohe. I tētahi atu taha, ko te hoko mai i ngā rohe iti te utu me te kore he tirotiro tiwhikete pakari ka puta he hapa ture me te kounga kino. Mā tētahi huarahi taurite ka tohaina pea te 70% ki te 80% o te rōrahi mō ngā rauemi niho nui ki ngā kaiwhakarato matua kua whakapumautia, kua tino whaimana (FDA/CE/ISO), me te whakawhanake i ngā kaiwhakarato tuarua kei a rātou te ISO 13485 me te kaha ki te haumi ki ngā ara FDA/CE. Mā tēnei rautaki ka whakaratohia he hua utu me te taurite tuku me te pupuri i tētahi taumata pakari mō te mōrearea haumanu e whakaaetia ana.

Ngā Whakaaro Matua

• Ngā whakatau me ngā take tino nui mō ngā Kaiwhakarato Niho
• Ngā whakaritenga, ngā whakaritenga, me ngā arowhai mōrearea e tika ana kia whakamanahia i mua i tō whakaae
• Ngā mahi whai muri me ngā whakatūpato ka taea e ngā kaipānui te tono tonu

Ngā Pātai Auau

He aha me whiriwhiri ai ahau i tētahi kaiwhakarato ratonga niho kua whakamanahia e te CE, FDA, me te ISO13485?

E whakaatu ana ēnei tiwhikete kei te tutuki i te kaiwhakarato ngā paerewa haumaru, kounga, me te tutuki i ngā whakaritenga e mōhiotia ana, e whakaiti ana i te mōrearea o te hua, ā, e āwhina ana ki te whakarite i ngā hoko ture i ngā mākete matua pēnei i te EU me te US.

He tiwhikete ā Denrotary mō te tuku ratonga orthodontic ā-ao?

Āe. E ai ki a Denrotary kei a ia ngā tiwhikete CE, FDA, me ISO13485, e tautoko ana i te hanga kounga-mana me te mahi tahi ā-ao māhorahora.

Ko ēhea ngā hua Denrotary e tino whai hua ana mai i te hanga whaimana?

Ko ngā taonga matua mō te tiaki niho pērā i ngā whāriki here-whaiaro, ngā ngongo paparinga, ngā waea āwhata, ngā mekameka hiko, me ngā pliers ka hua ake nā te pai ake o te ōritetanga, te ngāwari ki te whai i ngā niho, me te haumaru ake o te mahi haumanu.

Me pēhea te āwhina a ngā tiwhikete i ngā kaihoko ki te karo i ngā raruraru mekameka tuku?

Kāore e tino tūpono ana ngā kaiwhakarato whaimana ki te tūtaki ki ngā aukati ture, ki ngā arotake kore rānei. Mā tēnā ka āwhina i ngā wāhi rongoā me ngā kaituku ki te pupuri i te pūtake pumau me te karo i ngā raruraru tuku ohorere, urunga rānei ki te mākete.

He aha ngā tohu kounga whai hua me tirotiro e au i tua atu i ngā tiwhikete?

Pātai atu mō te āheinga o te whai i ngā puranga, ngā tuhinga whakamātautau hua, ngā taipitopito rauemi, me te kaha o te wheketere. Mō Denrotary, ko ngā tauira ko ngā awheawhe taumata hauora, ngā taputapu Tiamana, me ngā raina whakaputa whāriki aunoa.