Ukungenisa iibrakethi ezizibophelelayo eziqinisekisiweyo ze-CE/FDA kufuna ukuba unamathele ngokucokisekileyo kwimigaqo ethile. Uqinisekisa ukhuseleko lwemveliso, ukusebenza kakuhle, kunye nokufikelela kwimarike ngale mithetho. Le posi yebhlog inika uluhlu olupheleleyo lokuthobela imithetho kubathumeli be-Orthodontic Self Ligating Brackets-passive.
Izinto ezibalulekileyo ekufuneka ziqwalaselwe
- Abangenisi bempahla kwamanye amazwe kufuneka balandele imithetho engqongqo ye-CE kunye ne-FDA. Oku kuqinisekisa ukuba izixhobo zonyango zikhuselekile kwaye ziyafikeleleka kwimarike.
- Zombini iziqinisekiso ze-CE kunye ne-FDA zibalulekile. Zivumela ukuthengiswa eYurophu nase-US kwaye zibonisa umgangatho wemveliso.
- Soloko ujonga iziqinisekiso zomenzi kunye neelebheli zemveliso. Oku kuthintela iingxaki kwaye kuqinisekisa ukungeniswa okuhamba kakuhle.
Ukuqonda iziqinisekiso ze-CE kunye ne-FDA ze-Orthodontic Self Ligating Brackets-passive
Yintoni i-CE Marking yeZixhobo zonyango?
Kufuneka uqonde uphawu lwe-CE. Luqinisekisa ukuba isixhobo sezonyango siyahlangabezana nemigangatho yempilo, ukhuseleko, kunye nokukhuselwa kwendalo ye-European Union. Abavelisi bancamathisela uphawu lwe-CE. Olu phawu luyimfuneko kwiimveliso ezithengiswa ngaphakathi kwiCandelo lezoQoqosho laseYurophu (EEA). Lubonisa ukuba imveliso yakho iyahambelana nayo yonke imiyalelo kunye nemigaqo efanelekileyo ye-EU. Oku kuqukaUlawulo lweZixhobo zezoNyango (i-MDR)kwizixhobo ezifana ne-Orthodontic Self Ligating Brackets-passive. Ubonisa ukuthobela iimfuno ezibalulekileyo ngokuba nolu phawu. Oku kuqinisekisa ukuhamba ngokukhululekileyo kwemveliso yakho kwimarike enye ye-EU.
Yintoni i-FDA Clearance okanye i-Appointment ye-FDA yeZixhobo zonyango?
I-US Food and Drug Administration (FDA) ilawula izixhobo zonyango e-United States. Uza kufumana imvume ye-510(k) okanye imvume yangaphambi kweMarike (PMA). I-510(k) isebenza kwizixhobo ezilingana kakhulu nezo zikhoyo. I-PMA yeyokusetyenziswa kwezixhobo ezinobungozi obuphezulu. Zombini ezi nkqubo ziqinisekisa ukuba isixhobo sakho sikhuselekile kwaye siyasebenza ekusetyenzisweni kwaso kwimarike yase-US. Kufuneka uhambe kwezi ndlela ukuze uthengise ngokusemthethweni iimveliso zakho e-United States. Olu vavanyo luqatha lukhusela impilo yoluntu.
Kutheni Zombini Iziqinisekiso Zibalulekile Ukuze Ufikelele KwiMarike Yehlabathi
Ukufumana iziqinisekiso ze-CE kunye ne-FDA kuvula amathuba amakhulu emarike. Ukumakishwa kwe-CE kukuvumela ukuba uthengise kwimarike enkulu yaseYurophu. Imvume okanye imvume ye-FDA inika ukufikelela eMelika. Amanye amazwe amaninzi adla ngokuqaphela okanye amkele le migangatho ingqongqo njengemilinganiselo yeenkqubo zawo zolawulo. Ukuba nazo zombini iziqinisekiso ze-Orthodontic Self Ligating Brackets-passive yakho kubonisa ukuzibophelela okukhulu kwiumgangatho wehlabathi kunye nokhuseleko lwezigulaneOku kuthobela imithetho emibini kwandisa kakhulu ukufikelela kwimarike yakho. Kwakhona kwakha ukuthembana neengcali zezempilo kunye nezigulane kwihlabathi liphela, kubeka imveliso yakho njengenkokeli.
Ubuchule Bokungenisa Ngaphambi Kokungenisa Iibrakethi Ezizibophelelayo Ezingenamsebenzi
Ukuqinisekisa iziqinisekiso zoMvelisi (i-CE Mark, i-FDA 510(k) okanye i-PMA)
Kufuneka uqinisekise iziqinisekiso zomenzi. Soloko ujonga uphawu lwe-CE olusebenzayo. Khangela imvume ye-FDA 510(k) okanye imvume yangaphambi kweMarike (PMA). La maxwebhu angqina ukuthobela kwemveliso. Cela izatifikethi ezisemthethweni ngqo kumenzi. Kufuneka uqinisekise ubunyani bazo. Eli nyathelo libalulekileyo lithintela imiba yemithetho yexesha elizayo. Liqinisekisa ukuba imveliso yakho ihlangabezana nemigangatho ebalulekileyo yokhuseleko.
Ukuvavanya uHlelo lweMveliso kwiiBrackets ze-Orthodontic
Kufuneka uqonde udidi lwemveliso.Izibiyeli ze-OrthodonticNgokwesiqhelo ziiKlasi IIa phantsi kwemigaqo ye-EU. Ngokwesiqhelo ziizixhobo zeKlasi II ze-FDA. Olu luhlu luchaza iimfuno ezithile zomthetho. Ukwazi udidi oluchanekileyo kukunceda ulungiselele amaxwebhu achanekileyo. Kukwachaphazela uvavanyo olufunekayo kunye neembopheleleko zasemva kwemarike. Kufuneka uqinisekise olu luhlu kwangethuba.
Ukuqonda Iimfuneko Zokusetyenziswa Okucetywayo Nezokubhala Iilebheli
Chaza ngokucacileyo indlela ekucetywayo ukusetyenziswa ngayoizibiyeli ezizibophelelayo ezingashukumiyo. Le nkcazo ikhokela lonke icebo lakho lolawulo. Kufuneka uhlolisise zonke iimfuno zokulebula ngononophelo. Iilebula kufuneka zibandakanye ulwazi oluthile. Oku kudla ngokugubungela iinkcukacha zomenzi, igama lesixhobo, kunye nezilumkiso ezibalulekileyo. Qinisekisa ukuba iilebula zakho ziyahambelana nemithetho ye-CE kunye ne-FDA. Ukufakwa kweelebula ngendlela engalunganga kunokukhokelela ekulibazisekeni okanye ekwaliweni kokungeniswa kwemveliso.
Iziqinisekiso zoMboneleli kunye nokuqwalaselwa koPhicotho
Kufuneka ulungiselele ababoneleli bakho ngokupheleleyo. Yenza uhlolo lwezakhiwo zabo zokuvelisa. Vavanya inkqubo yabo yolawulo lomgangatho (i-QMS). Qinisekisa ukunamathela kwabo kwimigangatho yamazwe ngamazwe efana ne-ISO 13485. I-QMS eqinileyo iqinisekisa umgangatho wemveliso ohambelanayo. Ubudlelwane obuqinileyo nababoneleli, obakhelwe ekuthembekeni nasekuthobeleni imithetho, bubalulekile kwimpumelelo yakho. Olu qwalaselo lunciphisa iingozi kwaye lukhusela ishishini lakho.
Uluhlu lokuHlola ukuThotyelwa kweMithetho ye-CE lwabaThengisi beeBhakethi eziZithuthayo eziZithuthayo
Ukuhambahamba kuthotyelo lwe-CE kufuna indlela ecwangcisiweyo. Kufuneka uzalisekise iimbopheleleko ezininzi ezibalulekileyo njengomngenisi weebrakethi ezizibophelelayo. Olu luhlu lokutshekisha lukukhokela kwinyathelo ngalinye elibalulekileyo.
Ukuqesha ummeli ogunyazisiweyo
Kufuneka uqeshe uMmeli oGunyazisiweyo (i-AR) ukuba umenzi wakho ungaphandle kweManyano yaseYurophu. Le AR isebenza njengendawo yokunxibelelana nomenzi ngaphakathi kwe-EU. Baqinisekisa ukuthotyelwa kwemithetho ye-EU. I-AR yakho ijongana nonxibelelwano nabasemagunyeni belizwe. Bakwanceda ngemisebenzi yokujonga emva kwemarike. Khetha i-AR enolwazi kwimigaqo yezixhobo zonyango. Olu khetho lubalulekile ukuze kufikelelwe kwimarike ngokulula.
Ingcebiso:Igama kunye nedilesi yoMmeli wakho oGunyazisiweyo kufuneka zibonakale kwileyibhile yesixhobo. Oku kubonisa ngokucacileyo umntu onoxanduva ngaphakathi kwi-EU.
Ukuqinisekisa ukuFumaneka kweSibhengezo sokuThotyelwa kweMithetho (i-DoC)
Kufuneka uqinisekise ukuba iSibhengezo sokuThotyelwa kweMithetho (i-DoC) siyafumaneka. Umenzi ukhupha olu xwebhu. Luthi izibiyeli ezizibophelelayo zihlangabezana nazo zonke iimfuno zempilo nokhuseleko ze-EU. I-DoC iqinisekisa ukuthotyelwa kwemithethoUlawulo lweZixhobo zezoNyango (i-MDR).Kufuneka ube nekopi yale DoC. Abasemagunyeni banokuyicela nangaliphi na ixesha. Qinisekisa ukuba iDoC iyasebenza kwaye igubungela imveliso yakho ethile.
Ukuphonononga amaxwebhu obuchwephesha (ifayile yobuchwephesha)
Kufuneka uhlolisise uXwebhu loBugcisa lomenzi, olukwaziwa ngokuba yiFayile yoBugcisa. Le fayile ineenkcukacha ezithe vetshe malunga nesixhobo. Ibandakanya iinkcukacha zoyilo, uvavanyo lomngcipheko, kunye nedatha yovavanyo lweklinikhi. IFayile yoBugcisa ingqina ukhuseleko kunye nokusebenza kwesixhobo. Akunyanzelekanga ukuba ugcine yonke ifayile. Nangona kunjalo, kufuneka ukwazi ukuyinika abasemagunyeni xa uyicelile. Qonda umxholo wayo ukuqinisekisa ukucokiseka okufanelekileyo.
Iimfuneko zokulebhelisha kunye nemiyalelo yokusebenzisa (i-IFU)
Kufuneka uqinisekise ukuba zonke iilebhile kunye nemiyalelo yokusebenzisa (i-IFU) ziyahambelana neemfuno ze-CE. Iilebhile mazicace, zifundeke, kwaye zibe ngolwimi lwelizwe elililungu apho isixhobo sithengiswa khona. Kufuneka zibandakanye uphawu lwe-CE, igama lomenzi, idilesi, kunye neenkcukacha ze-AR. I-IFU inika ulwazi olubalulekileyo lokusetyenziswa ngokukhuselekileyo nangokufanelekileyo. Kufuneka ichaze iinkcukacha zeempawu, izithintelo, izilumkiso kunye namanyathelo okhuseleko. Iilebhile ezingachanekanga zinokukhokelela ekubuyiselweni kwemveliso.
Nazi izinto ezibalulekileyo zokubhala iilebheli:
- Uphawu lwe-CE:Ibonakala ngokucacileyo.
- Ulwazi loMvelisi:Igama kunye nedilesi.
- Ummeli oGunyazisiweyo:Igama kunye nedilesi.
- Igama lesixhobo:Ukuchongwa okucacileyo.
- Inombolo yeBatch/Lot:Ukuze kulandeleke.
- Ulwazi malunga nokungazali:Ukuba kuyangena.
- Umhla WOKUPHELELWA:Ukuba kuyangena.
- Ukuchonga isixhobo esikhethekileyo (i-UDI):Njengoko kufuneka yi-MDR.
Iimbopheleleko zoLawulo lwasemva kweMarike (PMS)
Unembopheleleko yokujonga emva kweMarike (PMS) njengomthumeli wemveliso. Oku kuthetha ukuba kufuneka ubeke iliso ekusebenzeni kwesixhobo xa sele sithengiswa. Kufuneka uxele naziphi na iziganeko ezinzulu kwabasemagunyeni abafanelekileyo. Ukwanegalelo ekuxeleni ngeziganeko eziqhubekayo. Oku kubandakanya ukuqokelela nokuhlaziya idatha yokusebenza kwesixhobo. Misela inkqubo yokufumana nokucubungula izikhalazo. Ukuthatha inxaxheba kwakho kwi-PMS kunceda ukuqinisekisa ukhuseleko oluqhubekayo lwesigulana.
Uluhlu lokuHlola ukuThotyelwa kweMithetho ye-FDA lwabaThengisi beeBrackets ze-Orthodontic Self Ligating - ezingasebenziyo
Kufuneka ujonge imigaqo ye-US Food and Drug Administration (FDA) ngononophelo. Olu luhlu lukukhokela kumanyathelo abalulekileyo okungenisa ii-Orthodontic Self Ligating Brackets-passive e-United States.
Ukubhalisa njengoMthumeli-mhlaba kwi-FDA
Kufuneka ubhalise indawo yakho kwi-FDA. Eli linyathelo elinyanzelekileyo. Usebenzisa iNkqubo yoBhaliso noLuhlu oluManyeneyo lwe-FDA (FURLS) kule nkqubo. Olu bhaliso lukuchonga njengomngenisi osemthethweni wezixhobo zonyango. Kufuneka uhlaziye olu bhaliso minyaka le. Ukungaphumeleli ukubhalisa kunokukhokelela ekulibazisekeni kokungenisa okanye ukwaliwa kokuthunyelwa kwakho.
Izixhobo zoLuhlu kunye ne-FDA
Kufuneka udwelise izixhobo ezithile ofuna ukuzingenisa kwi-FDA. Le yinkqubo eyahlukileyo kubhaliso lwakho lokungenisa. Unika ulwazi oluneenkcukacha malunga nohlobo ngalunye lwesixhobo. Oku kuquka ukuhlelwa kwaso kunye nokusetyenziswa kwaso okucetywayo. Kwi-Orthodontic Self Ligating Brackets-passive, uza kudwelisa iimodeli okanye iintlobo ezithile oceba ukuzisa kwimarike yase-US. Olu luhlu luqinisekisa ukuba i-FDA iyazi ukuba zeziphi izixhobo ozingenisayo.
Ukuqinisekisa Ukubhaliswa Kwezakhiwo Zomenzi kunye Noluhlu Lwezixhobo
Kufuneka uqinisekise ukuthobela komenzi wakho. Umenzi wangaphandle we-Orthodontic Self Ligating Brackets-passive yakho kufuneka abhalise nenkampani yakhe kwi-FDA. Kufuneka babhale phantsi izixhobo zabo. Awunakungenisa izixhobo kumenzi ongabhaliswanga okanye ongabhaliswanga. Cela ubungqina bobhaliso lwabo lwangoku kunye noluhlu lwabo. Eli nyathelo libalulekile ekuthobeleni kwakho.
Ukuqonda ukuThotyelwa kweMimiselo yoMgangatho (QSR) (21 CFR Part 820)
Kufuneka uqonde uMgaqo weNkqubo yoMgangatho (i-QSR). Lo mgaqo yi-21 CFR Part 820. Uqinisekisa ukuba izixhobo zonyango zikhuselekile. Uqinisekisa nokuba ziyasebenza. I-QSR igubungela iindlela, izibonelelo, kunye nolawulo olusetyenziswa ekuyileni, ekuveliseni, ekupakisheni, ekulebheleni, ekugcineni, ekufakeni, nasekulungiseni izixhobo zonyango. Unoxanduva lokuqinisekisa ukuba umenzi wakho wangaphandle uyayithobela i-QSR. Oku kuquka:
- Ulawulo loYilo:Ukuqinisekisa ukuba uyilo lwesixhobo luyahlangabezana neemfuno zomsebenzisi.
- Ulawulo lweMveliso kunye neNkqubo:Ukugcina umgangatho wokuvelisa ungaguquguquki.
- Amanyathelo Okulungisa Nokuthintela (i-CAPA):Ukujongana nokuthintela imiba yomgangatho.
- Uxanduva loLawulo:Ukuqinisekisa ukuba abaphathi abaphezulu bayayixhasa inkqubo esemgangathweni.
Phawula:Nangona umenzi esebenzisa ngokuthe ngqo i-QSR, wena, njengomngenisi, unoxanduva lokuqinisekisa ukuthotyelwa kwayo. Kuya kufuneka wenze uhlolo okanye ucele amaxwebhu ukuqinisekisa ukuthotyelwa kwayo.
Iimfuneko zokulebhelisha (21 CFR Icandelo 801)
Kufuneka ulandele iimfuno ezingqongqo zokubhala ilebheli ze-FDA. Ezi zichazwe kwi-21 CFR Part 801. Iilebheli zifuna ulwazi oluthile. Kufuneka zibe ngesiNgesi. Qinisekisa ukuba iilebheli zakho ziquka:
- Igama nedilesi yomenzi.
- Igama lesixhobo.
- Ukusetyenziswa okucetywayo.
- Naziphi na izilumkiso okanye amanyathelo okhuseleko afunekayo.
- Ukuchonga isixhobo esikhethekileyo (i-UDI).
- Imiyalelo yokusetyenziswa.
Ukubhalwa kweelebheli ngendlela engalunganga okanye engaphelelanga kunokubangela ukuba izixhobo zakho zibanjwe emdeni.
Iimbopheleleko zeNgxelo yeZixhobo zezoNyango (i-MDR)
Unembopheleleko yokuXela ngeZixhobo zoNyango (i-MDR). Kufuneka uxele iziganeko ezithile ezimbi kwi-FDA. Oku kuquka:
- Ukufa okunxulumene nesixhobo.
- Ukulimala okukhulu okunxulumene nesixhobo.
- Ukungasebenzi kakuhle kwesixhobo okunokubangela ukufa okanye ukwenzakala okukhulu ukuba siphinda sibuye.
Kufuneka umisele inkqubo yokuqokelela nokungenisa ezi ngxelo. Oku kuqinisekisa ukuba i-FDA ijonga ukhuseleko lwesixhobo ngokufanelekileyo.
Iinkqubo zokungenisa impahla engenayo kunye nokuSusa iRhafu
Kufuneka ulandele iinkqubo ezithile zokungena nokususa iimpahla ezithunyelwa kwamanye amazwe. I-FDA idlala indima ekucoceni izixhobo zonyango kumda wase-US. Kufuneka unikezele ngamaxwebhu afanelekileyo. Oku kuquka isaziso sokufika kwangaphambili. Kufuneka ungenise neefomu zokungena. I-FDA ingahlola ukuthunyelwa kwakho. Basenokubamba nezixhobo ukuba bakrokrela ukuba azithotyelwanga. Sebenzisana ngokusondeleyo nomthengisi wakho wempahla ezithunyelwa kwamanye amazwe. Qinisekisa ukuba onke amaphepha afunekayo achanekile kwaye aphelele. Oku kunceda ukuthintela ukulibaziseka.
Iingxaki Eziqhelekileyo Ekungeniseni Iibrakethi Ezizibophelelayo Nendlela Yokuziphepha
Ujongene nemingeni emininzi eqhelekileyo xa ungenisa izixhobo zonyango. Ukuqonda le migibe kukunceda uphephe iimpazamo ezibizayo. Ungaqinisekisa inkqubo yokungenisa ethe tye nethobelayo.
Amaxwebhu angaphelelanga
Uhlala uhlangabezana nokulibaziseka ngenxa yokungabikho kwamaxwebhu okanye ukungaphelelanga. Oku kuquka Izatifikethi ze-CE, imvume ye-FDAiileta, okanye iifayile zobugcisa. Amagosa erhafu aza kuyimisa imithwalo yakho ngaphandle kwamaphepha afanelekileyo. Kufuneka uqinisekise ngononophelo onke amaxwebhu afunekayo ngaphambi kokuba iimveliso zakho zithunyelwe.
Ukutolikwa gwenxa kweMithetho
Usenokungayichazi kakuhle imigaqo enzima ye-CE okanye ye-FDA. Le mithetho itshintsha rhoqo. Ukungaqondani kunokukhokelela ekungathotyelweni kwemithetho. Oku kukhokelela ekubuyiselweni kwemveliso okanye ukuvalwa kwemarike. Kuya kufuneka udibane neengcali zomthetho okanye uhlolisise rhoqo izikhokelo ezisemthethweni.
Ukungabikho kwenkqubo yokuqapha emva kweMarike
Usengozini yokufumana izohlwayo eziqatha ngaphandle kwenkqubo eqinileyo yokuqapha emva kwemarike. Kufuneka ubeke iliso ekusebenzeni kwesixhobo emva kokuthengiswa. Ukungaphumeleli ukuxela iziganeko okanye iindlela ezimbi kuphula imithetho. Misela iinkqubo ezicacileyo zokusingatha izikhalazo kunye nokuxela iziganeko.
Ukulebhelisha okungahambelaniyo okanye i-IFU
Ungalahlwa ukuba ilebheli yakho okanye imiyalelo yokusebenzisa (i-IFU) ayihlangabezani nemigangatho. Iilebheli kufuneka zibe nolwazi oluthile ngolwimi oluchanekileyo. Kufuneka zibandakanye neempawu ezifunekayo. Ukubhalwa kweelebheli ngendlela engalunganga kukhokelela ekubanjweni kwerhafu. Kufuneka uhlolisise ngononophelo zonke iilebheli ngokuthelekisa neemfuno ze-CE kunye ne-FDA.
Ukukhetha Abavelisi Abangathembekanga
Ubeka emngciphekweni yonke imisebenzi yakho ngokusebenzisana nabavelisi abangathembekanga. Abanye abavelisi abanazo iinkqubo zolawulo lomgangatho okanye iziqinisekiso ezifanelekileyo. Oku kukhokelela kwiimveliso ezikumgangatho ophantsi. Kufuneka wenze uphononongo olucokisekileyo kunye nokuhlolwa kwabo bonke ababoneleli abanokubakho.
Iindlela ezilungileyo zokuthobela rhoqo i-Orthodontic Self Ligating Brackets-passive Regulations
Kuya kufuneka ugcineukuthobela rhoqo.Oku kuqinisekisa ukuba iiBrackets zakho ze-Orthodontic Self Ligating Brackets-passive ezithunyelwe kwamanye amazwe zihlala zithengiswa. Amanyathelo asebenzayo athintela iingxaki zomthetho zexesha elizayo.
Uhlolo oluQhelekileyo lweeHlaziyo zeMithetho
Kufuneka uhlale unolwazi malunga notshintsho olulawulayo. Imithetho ye-CE kunye ne-FDA iyatshintsha. Jonga rhoqo izibhengezo ezisemthethweni ze-FDA kunye nohlaziyo lwemithetho ye-EU. Bhalisela iincwadana zeendaba zoshishino. Oku kukunceda ukuba uhlengahlengise iinkqubo zakho ngokukhawuleza.
Ukugcina iiRekhodi eziBanzi
Kufuneka ugcine iirekhodi ezicokisekileyo. Bhala phantsi zonke iinkalo zenkqubo yakho yokungenisa impahla. Oku kuquka izivumelwano zababoneleli, izibhengezo zokungenisa impahla, ukujonga umgangatho, kunye neengxelo zezikhalazo. Ezi rekhodi zibalulekile kuhlolo-zincwadi. Zibonisa ukunamathela kwakho kwimigaqo.
Ukuseka iinkqubo zangaphakathi zokuthobela imithetho
Kufuneka uphuhlise iinkqubo zangaphakathi ezicacileyo zokuthobela imithetho. Yenza iiNkqubo zokuSebenza eziMiselweyo (ii-SOP) zenyathelo ngalinye. Oku kuquka ukufumana, ukugcina, kunye nokusasaza. Iinkqubo ezihambelanayo zinciphisa iimpazamo. Ziqinisekisa ukuba bonke abasebenzi balandela izikhokelo zomthetho.
Abasebenzi boQeqesho kwiimfuno zoLawulo
Kufuneka uqeqeshe abasebenzi bakho ngokupheleleyo. Bafundise ngazo zonke iimfuno ze-CE kunye ne-FDA ezifanelekileyo. Oku kuquka ukulebhelisha, ingxelo yeziganeko ezimbi, kunye nolawulo lomgangatho. Abasebenzi abaqeqeshwe kakuhle bathintela ukungathobeli imithetho. Bayaqonda ukubaluleka kokuphatha iiBrackets ze-Orthodontic Self Ligating - ukungasebenzi ngokuchanekileyo.
Ukubandakanya iingcali zolawulo xa kuyimfuneko
Kuya kufuneka ucinge ngokubandakanya abacebisi bezomthetho. Banika isikhokelo sobuchwephesha kwimiba enzima. Abacebisi banokukunceda ukutolika imithetho emitsha. Bakwanceda ngokulungiselela uphicotho-zincwadi. Ubuchule babo buqinisekisa ukuba icebo lakho lokuthobela imithetho lihlala liqinile.
Ukulandela ubunzima bokuthobela i-CE kunye ne-FDA kwiibrakethi ezizibophelelayo kubalulekile ukuze ungenise ngempumelelo. Ngokulandela ngenyameko olu luhlu lupheleleyo, unokunciphisa ngempumelelo iingozi ezinokubakho. Uqinisekisa ukufikelela kwimarike ngaphandle kokuphazamiseka. Ukwagcina imigangatho ephezulu yokhuseleko lwezigulane.
FAQ
Leliphi inyathelo lokuqala omele ulithathe njengomthumeli wempahla kwamanye amazwe?
Kufuneka uqinisekise iziqinisekiso ze-CE kunye ne-FDA zomenzi. Oku kuqinisekisa ukuthobela imveliso kwasekuqaleni.
Ngaba uhlala ufuna zombini iziqinisekiso ze-CE kunye ne-FDA?
Ewe, uyazidinga zombini ukuze ufumane ukufikelela kwimarike yehlabathi. I-CE ivumela ukuthengiswa eYurophu, kwaye i-FDA ivumela ukuthengiswa eMelika
Kuza kwenzeka ntoni ukuba amaxwebhu akho akaphelelanga?
Amagosa erhafu aza kulibazisa okanye akwale ukuthunyelwa kwakho. Kufuneka uqinisekise ukuba onke amaphepha agqityiwe ngaphambi kokuba uthunyelwe.
Ixesha leposi: Novemba-11-2025