Ukungenisa ama-bracket azimele aqinisekisiwe yi-CE/FDA kudinga ukunamathela kwakho ngokucophelela ezimisweni ezithile zomthetho. Uqinisekisa ukuphepha komkhiqizo, ukusebenza kahle, kanye nokufinyelela emakethe ngalokhu kuthobela imithetho. Lokhu okuthunyelwe kwebhulogi kunikeza uhlu lokuhlola oluphelele lokuthobela imithetho lwabangenisi be-Orthodontic Self Ligating Brackets-passive.
Izinto Ezibalulekile Okufanele Uzicabangele
- Abangenisi kumele balandele imithetho eqinile ye-CE kanye ne-FDA. Lokhu kuqinisekisa ukuthi amadivayisi ezokwelapha aphephile kanye nokufinyelela emakethe.
- Zombili izitifiketi ze-CE kanye ne-FDA zibalulekile. Zivumela ukuthengiswa eYurophu nase-US futhi zibonisa ikhwalithi yomkhiqizo.
- Hlola njalo izitifiketi zomkhiqizi kanye namalebula omkhiqizo. Lokhu kuvimbela izinkinga futhi kuqinisekisa ukungeniswa okushelelayo.
Ukuqonda Izitifiketi ze-CE kanye ne-FDA ze-Orthodontic Self Ligating Brackets-passive
Kuyini Ukumaka kwe-CE Kwamadivayisi Ezokwelapha?
Kumelwe uqonde ukumakwa kwe-CE. Kuqinisekisa ukuthi idivayisi yezokwelapha ihlangabezana nezindinganiso zezempilo, ukuphepha, kanye nokuvikelwa kwemvelo ze-European Union. Abakhiqizi banamathisela uphawu lwe-CE. Lolu phawu luyimpoqo emikhiqizweni ethengiswa ngaphakathi kwe-European Economic Area (EEA). Lubonisa ukuthi umkhiqizo wakho uhambisana nazo zonke iziqondiso nemithethonqubo ye-EU efanele. Lokhu kufaka phakathiUkulawulwa Kwamadivayisi Ezokwelapha (i-MDR)kumadivayisi afana ne-Orthodontic Self Ligating Brackets-passive. Ubonisa ukuhambisana nezidingo ezibalulekile ngokuba nalolu phawu. Lokhu kuqinisekisa ukuhamba ngokukhululeka komkhiqizo wakho ngaphakathi kwemakethe eyodwa ye-EU.
Kuyini ukuvunyelwa noma ukuvunyelwa kwe-FDA kwamadivayisi ezokwelapha?
I-US Food and Drug Administration (FDA) ilawula amadivayisi ezokwelapha e-United States. Uzothola imvume ye-510(k) noma imvume yangaphambi kwemakethe (PMA). I-510(k) isebenza kumadivayisi afana kakhulu nalawo akhona. I-PMA ingeyamadivayisi anobungozi obukhulu. Zombili lezi zinqubo ziqinisekisa ukuthi idivayisi yakho iphephile futhi isebenza kahle ekusetshenzisweni kwayo okuhlosiwe emakethe yase-US. Kumelwe uhambe ngalezi zindlela ukuze uthengise imikhiqizo yakho ngokusemthethweni e-United States. Lokhu kuhlola okuqinile kuvikela impilo yomphakathi.
Kungani Zombili Izitifiketi Zibalulekile Ekufinyeleleni Imakethe Yomhlaba Wonke
Ukuthola izitifiketi ze-CE kanye ne-FDA kuvula amathuba emakethe abalulekile. Ukumakwa kwe-CE kukuvumela ukuthi uthengise emakethe enkulu yaseYurophu. Imvume noma imvume ye-FDA ivumela ukufinyelela e-United States. Amanye amazwe amaningi avame ukuqaphela noma amukele lezi zindinganiso eziqinile njengezilinganiso zezinhlelo zawo zokulawula. Ukuba nezitifiketi zombili ze-Orthodontic Self Ligating Brackets-passive yakho kubonisa ukuzibophezela okuqinile kuikhwalithi yomhlaba wonke kanye nokuphepha kwesiguliLokhu kuthobela imithetho okubili kwandisa kakhulu ukufinyelela emakethe yakho. Kwakha nokwethembana nochwepheshe bezempilo kanye neziguli emhlabeni wonke, kubeka umkhiqizo wakho njengomholi.
Ukuqapha Okufanelekile Kwangaphambi Kokungeniswa Kwamabhuleki Azibophayo Angenawo Amandla
Ukuqinisekisa Izitifiketi Zomkhiqizi (i-CE Mark, i-FDA 510(k) noma i-PMA)
Kumelwe uqinisekise izitifiketi zomkhiqizi. Hlola njalo i-CE Mark evumelekile. Bheka imvume ye-FDA 510(k) noma i-Pre-Market Approval (PMA). Le mibhalo ifakazela ukuthobela komkhiqizo. Cela izitifiketi ezisemthethweni ngqo kumkhiqizi. Kufanele futhi uqinisekise ubuqiniso bazo. Lesi sinyathelo esibalulekile sivimbela izinkinga zomthetho zesikhathi esizayo. Siqinisekisa ukuthi umkhiqizo wakho uhlangabezana nezindinganiso zokuphepha ezibalulekile.
Ukuhlola Ukuhlukaniswa Komkhiqizo Kwama-Bracket E-Orthodontic
Udinga ukuqonda ukuhlukaniswa komkhiqizo.Amabhuleki e-OrthodonticNgokuvamile ziyiSigaba IIa ngaphansi kwemithetho ye-EU. Ngokuvamile ziyizisetshenziswa zeSigaba II ze-FDA. Lokhu kuhlukaniswa kunquma izidingo ezithile zomthetho. Ukwazi isigaba esiqondile kukusiza ukuthi ulungiselele amadokhumenti afanele. Kuphinde kuthinte ukuhlolwa okudingekayo kanye nezibopho zangemuva kwemakethe. Kumelwe uqinisekise lokhu kuhlukaniswa kusenesikhathi.
Ukuqonda Izidingo Zokusetshenziswa Okuhlosiwe Nokulebula
Chaza ngokucacile ukusetshenziswa okuhlosiwe kweamabakaki azibophayo angenzi lutho. Le ncazelo iqondisa isu lakho lonke lokulawula. Kumelwe ubuyekeze zonke izidingo zokulebula ngokucophelela. Amalebula kudingeka afake ulwazi oluthile. Lokhu kuvame ukumboza imininingwane yomkhiqizi, igama ledivayisi, kanye nezixwayiso ezibalulekile. Qinisekisa ukuthi amalebula akho ahambisana nemithetho ye-CE kanye ne-FDA. Ukulebula okungalungile kungaholela ekubambezelekeni kokungenisa noma ekwenqatshweni.
Izimfanelo Zomhlinzeki kanye Nokucatshangelwa Kokuhlolwa Kwezimali
Kumelwe ufaneleke ngokuphelele kubaphakeli bakho. Yenza ukuhlolwa kwezindawo zabo zokukhiqiza. Hlola uhlelo lwabo lokuphatha ikhwalithi (i-QMS). Qinisekisa ukunamathela kwabo ezindinganisweni zomhlaba wonke njenge-ISO 13485. I-QMS eqinile iqinisekisa ikhwalithi yomkhiqizo eqhubekayo. Ubudlelwano obuqinile nabaphakeli, obakhelwe ekwethembeni nasekuthobeleni imithetho, bubalulekile empumelelweni yakho. Lokhu kuhlolisisa okufanele kunciphisa izingozi futhi kuvikele ibhizinisi lakho.
Uhlu Lokuhlola Lokuthobela Imithetho ye-CE Kwabangenisi Bezibhakethi Ezizibophezelayo Ezingenazibopho
Ukuzulazula ekuhambisaneni ne-CE kudinga indlela ehlelekile. Kumelwe ugcwalise izibopho eziningana ezibalulekile njengomngenisi wama-bracket azimele. Lolu hlu lokuhlola lukuqondisa esinyathelweni ngasinye esibalulekile.
Ukuqoka Ummeleli Ogunyaziwe
Kumelwe uqoke uMmeleli Ogunyaziwe (i-AR) uma umenzi wakho engaphandle kwe-European Union. Le AR isebenza njengendawo yokuxhumana nomenzi ngaphakathi kwe-EU. Iqinisekisa ukuthobela imithetho ye-EU. I-AR yakho iphatha ukuxhumana neziphathimandla zikazwelonke. Iphinde isize ngemisebenzi yokuqapha ngemuva kwemakethe. Khetha i-AR enolwazi ngemithethonqubo yedivayisi yezokwelapha. Lokhu kukhetha kubalulekile ukuze kufinyeleleke kalula emakethe.
Icebiso:Igama nekheli lommeli wakho ogunyaziwe kumele kuvele kulebula yedivayisi. Lokhu kuchaza ngokucacile iqembu elinomthwalo wemfanelo ngaphakathi kwe-EU.
Ukuqinisekisa Ukutholakala Kwesimemezelo Sokuhambisana (i-DoC)
Kumelwe uqinisekise ukuthi iSimemezelo Sokuhambisana (i-DoC) siyatholakala. Umenzi ukhipha lo mbhalo. Uthi amabhuleki azimele ahlangabezana nazo zonke izidingo zezempilo nokuphepha ze-EU ezifanele. I-DoC iqinisekisa ukuhambisana nomthetho.Ukulawulwa Kwamadivayisi Ezokwelapha (i-MDR).Udinga ukuba nekhophi yale DoC. Iziphathimandla zingayicela noma nini. Qinisekisa ukuthi i-DoC iyamanje futhi ihlanganisa umkhiqizo wakho othize.
Ukubukeza Amadokhumenti Obuchwepheshe (Ifayela Lobuchwepheshe)
Kufanele ubuyekeze Imibhalo Yobuchwepheshe yomkhiqizi, eyaziwa nangokuthi Ifayela Lobuchwepheshe. Leli fayela liqukethe ulwazi oluningiliziwe mayelana nedivayisi. Lihlanganisa imininingwane yomklamo, ukuhlolwa kwezingozi, kanye nedatha yokuhlola imitholampilo. Ifayela Lobuchwepheshe lifakazela ukuphepha nokusebenza kwedivayisi. Awudingi ukugcina lonke ifayela. Kodwa-ke, kufanele ukwazi ukulinikeza iziphathimandla uma ulicela. Qonda okuqukethwe kwalo ukuze uqinisekise ukucophelela okufanele.
Izidingo Zokubhala Amalebula Nemiyalelo Yokusebenzisa (IFU)
Kumelwe uqinisekise ukuthi konke ukulebula kanye nemiyalelo yokusebenzisa (i-IFU) kuyahambisana nezimfuneko ze-CE. Amalebula kumele acace, afundeke, futhi abe ngolimi lwezwe eliyilungu lapho idivayisi ithengiswa khona. Kumelwe afake uphawu lwe-CE, igama lomenzi, ikheli, kanye nemininingwane ye-AR. I-IFU inikeza ulwazi olubalulekile lokusetshenziswa okuphephile nokufanelekile. Kumelwe ichaze izinkomba, iziphambeko, izixwayiso, kanye nezinyathelo zokuphepha. Ukulebula okungalungile kungaholela ekubuyiselweni komkhiqizo.
Nazi izinto ezibalulekile zokulebula:
- Uphawu lwe-CE:Kuyabonakala kahle.
- Ulwazi Lomkhiqizi:Igama nekheli.
- Ummeleli Ogunyaziwe:Igama nekheli.
- Igama Ledivayisi:Ukuhlonza okucacile.
- Inombolo Yeqembu/Yesabelo:Ukuze kulandeleke.
- Ulwazi Lokungazali:Uma kusebenza.
- Usuku lokuphelelwa isikhathi:Uma kusebenza.
- Ukuhlonza Idivayisi Eyingqayizivele (i-UDI):Njengoba kudingeka yi-MDR.
Izibopho Zokuqapha Ngemva Kwemakethe (PMS)
Unezibopho Zokuqapha Ngemva Kwemakethe (PMS) njengomngenisi. Lokhu kusho ukuthi kufanele uqaphe ukusebenza kwedivayisi uma isithengiswa. Udinga ukubika noma yiziphi izehlakalo ezingathi sína eziphathimandleni ezifanele. Uphinde ube negalelo ekubikeni kwezitayela. Lokhu kuhilela ukuqoqa nokubuyekeza idatha ngokusebenza kwedivayisi. Misa uhlelo lokwamukela nokucubungula izikhalazo. Ukuhlanganyela kwakho okusebenzayo ku-PMS kusiza ukuqinisekisa ukuphepha kwesiguli okuqhubekayo.
Uhlu Lokuhlola Lokuthobela Imithetho ye-FDA Lwabathumeli Bezibhulokhi Zokuzibopha Ze-Orthodontic - abangasebenzi
Kumelwe uhlole imithethonqubo ye-US Food and Drug Administration (FDA) ngokucophelela. Lolu hlu lokuhlola lukuqondisa ngezinyathelo ezibalulekile zokungenisa ama-Orthodontic Self Ligating Brackets-passive e-United States.
Ukubhalisa njengoMthumeli we-FDA
Kumelwe ubhalise indawo yakho ne-FDA. Lesi yisinyathelo esiyimpoqo. Usebenzisa i-FDA Unified Registration and Listing System (FURLS) kule nqubo. Lokhu kubhalisa kukukhomba njengongenisa ngokusemthethweni amadivayisi ezokwelapha. Kumelwe uvuselele lokhu kubhaliswa minyaka yonke. Ukwehluleka ukubhalisa kungaholela ekubambezelekeni kokungenisa noma ukwenqatshwa kokuthunyelwa kwakho.
Ukufaka Amadivayisi ohlwini ne-FDA
Kumelwe ubhale phansi amadivayisi athile ohlose ukuwangenisa ne-FDA. Lena inqubo ehlukile ekubhalisweni kwakho kokungenisa. Uhlinzeka ngolwazi oluningiliziwe mayelana nohlobo ngalunye lwedivayisi. Lokhu kufaka phakathi ukuhlukaniswa kwayo kanye nokusetshenziswa okuhlosiwe. Kuma-Orthodontic Self Ligating Brackets-passive, uzobhala phansi amamodeli noma izinhlobo ezithile ohlela ukuziletha emakethe yase-US. Lokhu kufakwa ohlwini kuqinisekisa ukuthi i-FDA iyazi ukuthi yimaphi amadivayisi owangenisayo.
Ukuqinisekisa Ukubhaliswa Kwezakhiwo Zomkhiqizi kanye Nokufakwa Kuhlu Kwamadivayisi
Kumelwe uqinisekise ukuthobela imithetho komkhiqizi wakho. Umkhiqizi wangaphandle we-Orthodontic Self Ligating Brackets-passive yakho kumele futhi abhalise inkampani yakhe ne-FDA. Kumelwe abhale phansi amadivayisi akhe. Awukwazi ukungenisa amadivayisi kumkhiqizi ongabhalisiwe noma ongabhalisiwe. Cela ubufakazi bokubhaliswa kwawo kwamanje kanye nokufakwa ohlwini. Lesi sinyathelo sibalulekile ekuthobeleni imithetho kwakho.
Ukuqonda Ukuhambisana Nomthetho Wesistimu Yekhwalithi (QSR) (21 CFR Ingxenye 820)
Kumelwe uqonde uMthethonqubo Wekhwalithi (i-QSR). Lo mthethonqubo uyingxenye 820 ye-CFR engu-21. Uqinisekisa ukuthi amadivayisi ezokwelapha aphephile. Uqinisekisa nokuthi ayasebenza. I-QSR ihlanganisa izindlela, izikhungo, kanye nezilawuli ezisetshenziswa ekuklameni, ekukhiqizeni, ekupakisheni, ekulebheleni, ekugcineni, ekufakeni, nasekuhlinzekeni amadivayisi ezokwelapha. Unesibopho sokuqinisekisa ukuthi umenzi wakho wangaphandle uyahambisana ne-QSR. Lokhu kufaka phakathi:
- Izilawuli Zokuklama:Ukuqinisekisa ukuthi umklamo wedivayisi uyahlangabezana nezidingo zomsebenzisi.
- Ukulawulwa Kokukhiqiza Nezinqubo:Ukugcina ikhwalithi yokukhiqiza ehambisanayo.
- Izenzo Zokulungisa Nokuvimbela (i-CAPA):Ukubhekana nokuvimbela izinkinga zekhwalithi.
- Umthwalo Wemfanelo Wokuphatha:Ukuqinisekisa ukuthi abaphathi abaphezulu basekela uhlelo lwekhwalithi.
Qaphela:Nakuba umenzi esebenzisa i-QSR ngokuqondile, wena, njengomngenisi, unesibopho sokuqinisekisa ukunamathela kwayo. Kufanele wenze ukuhlolwa noma ucele imibhalo ukuqinisekisa ukuthobela kwayo.
Izidingo Zokulebula (21 CFR Ingxenye 801)
Kumelwe ulandele izidingo eziqinile zokulebula ze-FDA. Lokhu kuchazwe kabanzi ku-21 CFR Part 801. Amalebula adinga ulwazi oluthile. Kumelwe abe ngesiNgisi. Qinisekisa ukuthi amalebula akho afaka:
- Igama nekheli lomenzi.
- Igama ledivayisi.
- Ukusetshenziswa okuhlosiwe.
- Noma yiziphi izixwayiso noma izinyathelo zokuphepha ezidingekayo.
- Ukuhlonza Idivayisi Eyingqayizivele (i-UDI).
- Iziqondiso zokusebenzisa.
Ukulebula okungalungile noma okungaphelele kungabangela ukuthi amadivayisi akho abanjwe emngceleni.
Izibopho Zokubika Amadivayisi Ezokwelapha (i-MDR)
Unezibopho Zokubika Amadivayisi Ezokwelapha (i-MDR). Kumelwe ubike izenzakalo ezithile ezimbi ku-FDA. Lokhu kufaka phakathi:
- Ukufa okuhlobene nedivayisi.
- Ukulimala okukhulu okuhlobene nedivayisi.
- Ukungasebenzi kahle kwedivayisi okungaholela ekufeni noma ekulimaleni okukhulu uma kuphinde kwenzeka.
Kumelwe usungule uhlelo lokuqoqa nokuthumela le mibiko. Lokhu kuqinisekisa ukuthi i-FDA iqapha ukuphepha kwedivayisi ngempumelelo.
Izinqubo Zokungena Nokuvunyelwa Kwentela
Kumelwe ulandele izinqubo ezithile zokungena nokukhishwa kwezimpahla. I-FDA idlala indima ekususeni amadivayisi ezokwelapha emngceleni wase-US. Kumelwe unikeze amadokhumenti afanele. Lokhu kufaka phakathi isaziso sokufika kusengaphambili. Kudingeka futhi uthumele amafomu okungena. I-FDA ingahlola ukuthunyelwa kwakho. Bangase futhi babambe amadivayisi uma besola ukuthi awalandelwanga. Sebenzisana eduze nomthengisi wakho wezimpahla. Qinisekisa ukuthi wonke amaphepha adingekayo anembile futhi aphelele. Lokhu kusiza ukugwema ukubambezeleka.
Izingibe Ezivamile Ekungeniseni Amabhuleki Azibophezelayo Nokuthi Ungazigwema Kanjani
Ubhekene nezinselele eziningana ezivamile lapho ungenisa amadivayisi ezokwelapha. Ukuqonda lezi zingibe kukusiza ugweme amaphutha abizayo. Ungaqinisekisa inqubo yokungenisa ebushelelezi nehambisanayo.
Amadokhumenti Angaphelele
Uvame ukubhekana nokubambezeleka ngenxa yokuntuleka kwamadokhumenti noma ukungaphelele. Lokhu kufaka phakathi Izitifiketi ze-CE, imvume ye-FDAizincwadi, noma amafayela obuchwepheshe. Izikhulu zentela zizomisa ukuthunyelwa kwakho ngaphandle kwamaphepha afanele. Kumelwe uqinisekise ngokucophelela wonke amadokhumenti adingekayo ngaphambi kokuba imikhiqizo yakho ithunyelwe.
Ukuhunyushwa Kabi Kwemithethonqubo
Ungase uqonde kabi imithethonqubo ye-CE noma ye-FDA eyinkimbinkimbi. Le mithetho ishintsha njalo. Ukungaqondi kahle kungaholela ekungalandelini imithetho. Lokhu kuholela ekubuyiselweni komkhiqizo noma ekuvinjelweni kwemakethe. Kufanele uthintane nochwepheshe bezomthetho noma ubuyekeze njalo isiqondiso esisemthethweni.
Ukuntuleka Kohlelo Lokuqapha Ngemva Kwemakethe
Usengozini yokuthola izinhlawulo ezinzima ngaphandle kohlelo oluqinile lokuqapha ngemuva kwemakethe. Kumelwe uqaphe ukusebenza kwedivayisi ngemva kokuthengisa. Ukwehluleka ukubika izehlakalo noma izitayela ezimbi kwephula imithetho. Misa izinqubo ezicacile zokusingatha izikhalazo kanye nokubika izehlakalo.
Ukulebula Okungahambisani Nemithetho noma i-IFU
Ungabhekana nokwenqatshwa uma ilebula lakho noma imiyalelo yokusebenzisa (i-IFU) ingahlangabezani nezindinganiso. Amalebula kumele aqukathe ulwazi oluthile ngolimi olufanele. Kumele futhi afake izimpawu ezidingekayo. Ukufakwa kwelebula okungalungile kuholela ekuboshweni kwamasiko. Kufanele ubukeze ngokucophelela konke ukufakwa kwelebula uqhathanisa nezidingo ze-CE kanye ne-FDA.
Ukukhetha Abakhiqizi Abangathembekile
Ubeka yonke imisebenzi yakho engcupheni ngokubambisana nabakhiqizi abangathembekile. Abanye abakhiqizi abanazo izinhlelo zokuphatha ikhwalithi noma izitifiketi ezifanele. Lokhu kuholela emikhiqizweni engaphansi kwezinga. Kumelwe wenze ucwaningo olunzulu kanye nokuhlolwa kwabo bonke abahlinzeki abangaba khona.
Imikhuba Emihle Yokulandela Okuqhubekayo Imithetho Yokunamathela Kwama-Orthodontic Self Ligating Brackets-passive Regulations
Kumelwe ulondolozeukuthobela imithetho okuqhubekayo.Lokhu kuqinisekisa ukuthi ama-Orthodontic Self Ligating Brackets akho angenisiwe ahlala emakethe. Izinyathelo ezisebenzayo zivimbela izinkinga zomthetho zesikhathi esizayo.
Ukubuyekezwa Okuvamile Kwezibuyekezo Zomthetho
Kumelwe uhlale unolwazi mayelana nezinguquko zomthetho. Imithethonqubo ye-CE kanye ne-FDA iyashintshashintsha. Hlola njalo izimemezelo ezisemthethweni ze-FDA kanye nezibuyekezo zomthetho ze-EU. Bhalisela izincwadi zezindaba zemboni. Lokhu kukusiza ukuthi ulungise izinqubo zakho ngokushesha.
Ukugcina Amarekhodi Aphelele
Udinga ukugcina amarekhodi acophelelayo. Bhala phansi zonke izici zenqubo yakho yokungenisa. Lokhu kufaka phakathi izivumelwano zabahlinzeki, izimemezelo zokungenisa, ukuhlolwa kokulawulwa kwekhwalithi, kanye nemibhalo yezikhalazo. Lawa marekhodi abalulekile ekuhlolweni. Abonisa ukunamathela kwakho emithethweni.
Ukusungula Izinqubo Zokuthobela Umthetho Zangaphakathi
Kufanele uthuthukise izinqubo zangaphakathi ezicacile zokuthobela imithetho. Dala Izinqubo Zokusebenza Ezijwayelekile (ama-SOP) zesinyathelo ngasinye. Lokhu kuhlanganisa ukwamukela, ukugcina, kanye nokusabalalisa. Izinqubo ezihambisanayo zinciphisa amaphutha. Ziqinisekisa ukuthi bonke abasebenzi balandela iziqondiso zomthetho.
Abasebenzi Bokuqeqesha Ngezidingo Zokulawula
Kumelwe uqeqeshe abasebenzi bakho kahle. Bafundise ngazo zonke izidingo ze-CE kanye ne-FDA ezifanele. Lokhu kufaka phakathi ukulebula, ukubika izenzakalo ezimbi, kanye nokulawula ikhwalithi. Abasebenzi abaqeqeshwe kahle bavimbela ukungalandeli imithetho. Bayaqonda ukubaluleka kokuphatha ama-Orthodontic Self Ligating Brackets - ukungasebenzi kahle.
Ukubandakanya Abeluleki Bezomthetho Uma Kudingeka
Kufanele ucabangele ukubandakanya abeluleki bezomthetho. Banikeza isiqondiso sochwepheshe ezindabeni eziyinkimbinkimbi. Abeluleki bangasiza ekuchazeni imithetho emisha. Baphinde basize ngokulungiselela ukuhlolwa. Ubuchwepheshe babo buqinisekisa ukuthi isu lakho lokuthobela imithetho lihlala liqinile.
Ukuzulazula ezinkingeni zokuhambisana ne-CE kanye ne-FDA ukuze uthole amabhuleki azimele angenawo ugesi kubalulekile ukuze kungeniswe ngempumelelo. Ngokulandela ngokucophelela lolu hlu lokuhlola oluphelele, unganciphisa ngempumelelo izingozi ezingaba khona. Uqinisekisa ukufinyelela emakethe okungenazihibe. Uphinde ulondoloze amazinga aphezulu okuphepha kweziguli.
Imibuzo Evame Ukubuzwa
Yisiphi isinyathelo sokuqala okufanele usithathe njengomthengisi wezimpahla?
Kumelwe uqinisekise izitifiketi ze-CE kanye ne-FDA zomkhiqizi. Lokhu kuqinisekisa ukuthobela imithetho yomkhiqizo kusukela ekuqaleni.
Ingabe uhlala udinga izitifiketi ze-CE kanye ne-FDA?
Yebo, udinga kokubili ukuze ufinyelele emakethe yomhlaba wonke. I-CE ivumela ukuthengisa eYurophu, kanti i-FDA ivumela ukuthengisa e-US
Kwenzekani uma amadokhumenti akho engaphelele?
Izikhulu zentela zizolibazisa noma zenqabe ukuthunyelwa kwakho. Kumelwe uqinisekise ukuthi wonke amaphepha aphelele ngaphambi kokuthunyelwa.
Isikhathi sokuthunyelwe: Novemba-11-2025