Abatanga amagufwa ya orthopedic: Imfashanyigisho ifatika yo kugenzura ibikoresho n'ibikoresho muri Amerika

Guhitamo abaganga orthopedic ntabwo ari igiciro cyibice gusa. Ku bagurisha bagurisha mu bitaro byo muri Amerika no mu bigo byo kubaga, icyemezo cy’abatanga isoko kiba icyemezo cy’ingaruka: gutinda kwinyandiko bishobora kwica amasoko, ibibazo byerekana ibimenyetso bishobora guhagarika ibicuruzwa, kandi icyuho gishobora gukurikiranwa gishobora guhindura ikirego gito mubisubizo byuzuye byo kwibuka.

Aka gatabo ni urwego rwo kumenyekanisha ibyiciro: rusobanura icyo 'abatanga amagufwa ' mubisanzwe bivuga, uko urwego rutanga amasoko rukora, ibyo shingiro ryubahiriza Amerika ukwiye kumenya, hamwe nurutonde rufatika ushobora gukoresha kugirango wuzuze abatanga ibikoresho byimyororokere nibikoresho.

Ibyingenzi byingenzi

• 'Abatanga amagufwa ya orthopedic ' barashobora gusobanura uwabikoze, uwakoze amasezerano, cyangwa umugabuzi / relabeler - gusobanura inshingano mbere yo gusuzuma.

• Muri Reta zunzubumwe za Amerika, uzoshaka gutahura uburyo FDA 510 (k) itomora ikoreshwa muburyo bwinshi bwimikorere yimikorere nuburyo bwo kugenzura ibimenyetso byibanze byubahirizwa.

• Impamyabumenyi ikomeye itanga isoko ni inyandiko-yambere: gukurikiranwa, kugenzura impinduka, sterilisation / gupakira ibyemewe (mugihe bibaye ngombwa), na CAPA indero irenze ibyo gusaba kwamamaza.

• Gukurikirana UDI ntabwo ari ibimenyetso byerekana gusa - ni inkingi yo kwibuka kwitegura no kubara neza.

Icyo 'abatanga amagufwa ' bisobanura (n'impamvu ijambo riteye urujijo)

Mubikorwa, abantu bakoresha 'abatanga amagufwa ' nk'incamake ya sosiyete iyo ari yo yose ishobora guhora itanga imiti n'ibikoresho - amasahani n'imigozi, imisumari itemewe, sisitemu yo gukosora uruti rw'umugongo, sisitemu yo kongera kubaka, hamwe n'ibikoresho bikenewe kugira ngo babishyiremo.

Ariko ijambo rihisha ingingo yingenzi: 'utanga ' mumasezerano yawe ashobora kuba:

• Uruganda rwemewe / labeler (urwego rushinzwe kuranga, gutanga amabwiriza, hamwe ninshingano nyuma yisoko)

• Uruganda rukora amasezerano rutanga labeler itandukanye

• Ikwirakwiza relabeler cyangwa ( ishobora guhindura inshingano zubuyobozi)

Mbere yo gutsinda amanota, sobanura ibibazo bibiri:

1. Ninde wanditseho ibikoresho uzagurisha muri Amerika?

2. Ni ikihe kigo gifite ibyangombwa bigenga n'inzira yo kugenzura?

Ibyo bisubizo byerekana icyo ushobora kugenzura - kandi ninde uzabazwa iyo hari icyahindutse.

Uburyo imitekerereze ya orthopedic itangwa mubisanzwe ikora

Reba ibintu byoroshye bisa nkibi:

1. Ibikoresho bibisi (urugero, titanium alloy, cobalt-chrome, PEEK kubice bimwe)

2. Gukora + inzira zidasanzwe (gutunganya, kurangiza hejuru, gusukura; hiyongereyeho sterisizione kubicuruzwa bidafite sterile)

3. Gupakira + kuranga (harimo ibisabwa bya UDI igihe bisabwa)

4. Kurekura ubuziranenge + inyandiko zerekana (ubufindo / ibyiciro bigenzura, inyandiko zimeze nka DHR, ibiti byo kugenzura)

5. Kwohereza / gutumiza mu mahanga + gukwirakwiza (gasutamo, ububiko, gutanga ibitaro, kohereza)

Kubakwirakwiza, gutanga-urunigi kwizerwa mubisanzwe 'yatsinze ' cyangwa 'yatakaye ' ahantu habiri:

• Sisitemu yubuziranenge : Igenzura ninyandiko birakomeye bihagije kugirango batsinde ubugenzuzi kandi bikore impinduka neza?

• Indero y'ibikorwa : Ese ibihe byo kuyobora, ubushobozi, n'itumanaho birahanurwa bihagije kugirango wirinde ububiko no gutsindwa kw'amasoko?

Ibyingenzi byubahiriza Amerika bikwiye kumvikana mbere yo gutoranya abatanga isoko

Ntugomba kuba inzobere mu bijyanye n’ubuyobozi kugira ngo wemererwe n’abatanga amagufwa - ariko ukeneye gusobanukirwa neza niki gishobora (kandi kidashobora) kugenzurwa.

1) FDA 510 (k): icyo aricyo n'impamvu bifite akamaro

Gutera amagufwa menshi bigengwa nkibikoresho byubuvuzi muri Amerika, kandi ubwoko bwibikoresho byinshi byinjira ku isoko binyuze mu nzira ya 510 (k) ya FDA (kumenyesha premarket).

FDA isobanura ubwoko bwinshi bwa 510 (k) bwo gutanga no kwerekana ko, kubwoko bumwebumwe bwibikoresho byunvikana neza, Inzira yumutekano n’imikorere ishobora gukoreshwa muburyo bwa 510 (k) - aho abayitanga bashingira kubipimo ngenderwaho byagaragajwe na FDA aho kugerageza kugereranya mu buryo bumwe na bumwe. Reba FDA Umutekano nImikorere Bishingiye ku Nzira 510 (k) yoherejwe.

Icyo wakora nkuwagabanije: baza uwaguhaye isoko kumibare 510 (k) ijyanye nibikoresho byihariye uteganya gukwirakwiza, kandi ubike inyandiko igenzurwa yerekana umubare wibice byerekana ikarita.

2) Kugenzura iyandikwa ryibigo no kurutonde rwibikoresho (ariko wumve icyo bidasobanura)

FDA ituma ibigo byiyandikisha hamwe nibikoresho byerekana urutonde biboneka hakoreshejwe ibikoresho rusange, harimo Urupapuro rwa FDA rwo Kwiyandikisha no Kwandika Urutonde (ruhuza ububiko bushakishwa).

Ibi ni ingirakamaro mu kugenzura ko ikigo kiri muri sisitemu n'ibikorwa / ibikoresho byashyizwe ku rutonde - ariko kwiyandikisha / kurutonde byonyine ntibigomba gufatwa nk'ikimenyetso cy'ubuziranenge bw'ibicuruzwa.

3) Gukurikirana UDI: menya ibyingenzi

FDA yashyizeho urwego rwa UDI kugirango imenye ibikoresho binyuze mugukwirakwiza no gukoresha. Intangiriro nziza ni ururimi-rworoshye FDA UDI shingiro (DI na PI).

Ku rwego rwo hejuru:

• DI (Ikiranga Igikoresho) igaragaza icyitegererezo / verisiyo yigikoresho.

• PI (Ibiranga umusaruro) irashobora gushiramo ubufindo / icyiciro, inomero yuruhererekane, nandi makuru yumusaruro.

Impamvu abadandaza bagomba kwitondera: UDI ninkingi ifatika yo kwibuka ibyakozwe, kubara neza, hamwe nibiteganijwe gukurikiranwa (ibitaro hamwe nuburyo bwo kugura amatsinda bigenda byitezwe ko amakuru ya UDI atemba).

Urutonde rwimpamyabushobozi ifatika kubatanga amagufwa

Iki nigice amakipe menshi yifuza ko yagira mbere yigihe ntarengwa cyambere.

A. Inyandiko ugomba gusaba mbere yikindi kintu cyose

Intego yo guteranya 'utanga isoko bikwiye umwete ' ushobora kongera gukoresha mumasoko:

• Impamyabumenyi nziza (urugero, ISO 13485 igipimo, gutanga umubiri, amatariki yemewe)

• Inyandiko zerekana imiterere ijyanye ningamba zo kwinjira ku isoko (urugero, gukuraho ibikoresho aho bishoboka)

• Incamake ya traceability (kugenzura / kugenzura, kuranga, uko UDI icungwa)

• Sterilisation yo kwemeza incamake (kubintu byatewe / ibikoresho)

• Gupakira kwemeza incamake (sterile barrière ubuziranenge no kugabura)

• Hindura politiki yo kugenzura (uburyo bamenyesha abakiriya, niki gitera revalidation)

• Gukemura ibibazo + Incamake ya CAPA (uko ibibazo bikurikiranwa kandi bikumirwa)

Ibyingenzi byingenzi : Niba utanga isoko adashobora gutanga paki yuzuye isukuye, yumvikana neza, uzayishyura nyuma - mugutinda kumasoko, gufata ibicuruzwa, cyangwa kubabaza inyuma-mugihe mugihe cyubugenzuzi.

B. Kugenzura ibice byibandwaho (ibyo kureba kurubuga cyangwa mubugenzuzi bwimbitse)

Mugihe ugenzura (cyangwa komisiyo y'ubugenzuzi), wibande kubigenzuzi byerekana guhuzagurika:

• Imyitozo ya Traceability : 'Nyereka uburyo ukurikirana iyi SKU kuva mubikoresho fatizo kugeza kubyoherejwe. '

• Indero yo kwemeza inzira : inzira zidasanzwe nka sterisizione hamwe nugupakira bigomba kugira ibimenyetso byerekana neza.

• Kudakora hamwe na CAPA : barashobora kwerekana imizi-itera imitekerereze nigikorwa cyo gukumira gifatika?

• Amahugurwa nubushobozi : ninde wemerewe kurekura ibicuruzwa, kwemeza gutandukana, no gucunga impinduka?

• Abagenzuzi batanga : ni gute bujuje ibisabwa kandi bagakurikirana ibyabo bitanga isoko?

C. Ibipimo ngenderwaho bigira ingaruka kumasoko nyayo yo kwizerwa

Kubakwirakwiza, 'ubuziranenge ' ntabwo ari injeniyeri gusa-ni ukumenya niba uwaguhaye isoko ashobora kugumana ububiko.

Saba ibyemezo byapimwe kandi bisobanutse kuri:

• Ibisobanuro-byambere bisobanura (bisanzwe na SKUs zisanzwe)

• Imbogamizi zubushobozi (bigenda bite mugihe cyibisabwa?)

• Guteganya no gutanga amategeko

• Ibicuruzwa / VMI amahitamo (niba yatanzwe)

• Itumanaho cadence: uko uzamenyeshwa ibijyanye no gutinda cyangwa guhinduka

Ibendera ritukura rihanura ibizaza, gutinda, cyangwa gutsindwa kw'amasoko

Koresha ibi nkibikorwa 'guhagarika no gukora iperereza ' urutonde:

• Impamyabumenyi zidafite intera isobanutse (ikubiyemo ibikorwa byubucuruzi ariko ntabwo ari inzira yo gukora)

• 'Dufite byose ' ibisabwa nta bimenyetso-byifashishwa (ibimenyetso, ibisobanuro byerekana)

• Nta nyandiko yanditse yo kumenyesha impinduka (cyangwa nta ngero zerekana itumanaho ryahindutse)

• Ibicuruzwa bya Sterile bisaba nta ncamake yemewe ushobora gusuzuma

• Kudasobanuka neza kubijyanye ninde labeler / uwakoze inyandiko

Gahunda yoroshye yiminsi 30 yumwete

Niba utangiriye kuri zeru, uru ni urutonde rufatika rutuma imirimo itunganijwe.

Iminsi 1-7: Uruhare rusobanutse + paki yinyandiko

• Emeza ninde labeler / uwakoze inyandiko kuri buri gikoresho cyumuryango.

• Saba igikwiye gikwiye (impamyabumenyi, ibisobanuro birambuye, incamake yo kwemeza).

• Ikarita yagenewe SKU kubiranga amabwiriza (aho bishoboka).

Iminsi 8–21: Kugenzura + gutegura ubugenzuzi

• Kugenzura ibimenyetso rusange (kwiyandikisha / gutondeka aho bibaye ngombwa; wemeze ibiranga ibikoresho).

• Kubaka urutonde rwubugenzuzi hafi yisoko ryawe nibitaro.

• Hitamo niba ugomba kugenzura neza cyangwa gukoresha undi muntu wujuje ibyangombwa.

Iminsi 22–30: Gahunda ya pilote + gusubiramo imikorere

• Tangira ukoresheje gahunda yo gutwara indege.

• Kurikirana itangwa ryokwizerwa, inyandiko zuzuye, ubwiza bwo gupakira, hamwe nubwitonzi.

• Andika ibyo wize - hanyuma uhitemo niba wapima.

Video: UDI shingiro muminota 3

Hano haribisobanuro bigufi bishobora gufasha guhuza kugurisha, ops, hamwe na QA kumpamvu UDI ifite akamaro kubikurikiranwa.

Video: 'Ibiranga FDA idasanzwe Ibiranga (UDI) Ibisabwa ' (Umubitsi mukuru)

Intambwe ikurikira

Niba ushaka intangiriro yo gusuzuma abaguzi, hindura urutonde hejuru kurupapuro rumwe rwo gutanga amanota hanyuma ukoreshe buri gihe kubakandida.

Niba ukeneye kandi urugero-rwukuri rwukuntu uruganda rugaragaza portfolio igipimo hamwe nibisabwa, urashobora gusuzuma amakuru rusange kuri XC Medico (urugero, urutonde rwibicuruzwa byashyizwe ku rutonde, kubara no kohereza ubutumwa), ishusho rusange yisosiyete kuri XC Medico Ibyerekeye Urupapuro , kandi - niba OEM / ODM igizwe nurugero rwawe-the Ubuyobozi buhebuje kuri orthopedic OEM & ODM Amasoko . Fata imbuga zitanga isoko nkintangiriro - hanyuma ugenzure inyandiko hamwe nibisobanuro mubikorwa byawe bwite.

Inshingano: Iyi ngingo igamije amakuru gusa kandi ntabwo igizwe ninama zamategeko cyangwa amategeko. Ibisabwa biratandukanye muburyo bwibikoresho nububasha.