Ukungenisa i-CE/FDA izibiyeli ezizibophelelayo eziqinisekisiweyo kufuna ukuba ubambelele ngobuchule kwizikhokelo ezithile zolawulo. Uqinisekisa ukhuseleko lwemveliso, ukusebenza kakuhle, kunye nokufikelela kwimarike ngokuthobela. Esi sithuba seblogi sibonelela ngoluhlu olubanzi lokuthotyelwa kwabarhwebi abavela kwamanye amazwe be-Orthodontic Self Ligating Brackets-passive.
Izinto eziphambili zokuThatha
- Abarhwebi abavela kwamanye amazwe kufuneka balandele imithetho engqongqo ye-CE kunye ne-FDA. Oku kuqinisekisa izixhobo zonyango ezikhuselekileyo kunye nokufikelela kwiimarike.
- Zombini i-CE kunye ne-FDA izatifikethi zibalulekile. Bavumela ukuthengisa eYurophu nase-US kwaye babonise umgangatho wemveliso.
- Soloko ujonga iziqinisekiso zomenzi kunye neelebhile zemveliso. Oku kuthintela iingxaki kwaye kuqinisekise ukungeniswa ngaphandle ngokutyibilikayo.
Ukuqonda i-CE kunye ne-FDA iziQinisekiso ze-Orthodontic Self Ligating Brackets-passive
Yintoni ukuMakishwa kweCE kwiZixhobo zoNyango?
Kuya kufuneka uqonde ukumakishwa kwe-CE. Iqinisekisa ukuba isixhobo sonyango siyahlangabezana nemigangatho yezempilo, ukhuseleko kunye nokhuseleko lwemo yendalo esingqongileyo ye-European Union. Abavelisi bancamathelisa uphawu lweCE. Olu phawu lusisinyanzelo kwiimveliso ezithengiswa ngaphakathi kwi-European Economic Area (EEA). Oku kuthetha ukuba imveliso yakho ithobela yonke imiyalelo kunye nemimiselo ye-EU efanelekileyo. Oku kubandakanya iUmmiselo wesixhobo soNyango (MDR)kwizixhobo ezifana ne-Orthodontic Self Ligating Brackets-passive. Ubonisa ukuthobela iimfuno ezibalulekileyo ngokuba nolu phawu. Oku kuqinisekisa ukuhamba ngokukhululekileyo kwemveliso yakho ngaphakathi kwimarike enye ye-EU.
Yintoni i-FDA Clearance okanye ukuVunywa kweZixhobo zoNyango?
I-US Food and Drug Administration (FDA) ilawula izixhobo zonyango eUnited States. Uya kudibana nokuba yi-510(k) imvume okanye i-Pre-Market Approval (PMA). I-510(k) isebenza kwizixhobo ezilingana kakhulu nezikhoyo. I-PMA yenzelwe izixhobo ezinomngcipheko ophezulu. Zombini ezi nkqubo ziqinisekisa ukuba isixhobo sakho sikhuselekile kwaye siyasebenza ekujoliswe kuso kwimarike yase-US. Kuya kufuneka ujonge ezi ndlela ukuze uthengise ngokusemthethweni iimveliso zakho eMelika. Olu vavanyo lungqongqo lukhusela impilo yoluntu.
Kutheni Zombini iziQinisekiso zibalulekile kuFikelelo lweMarike 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 lwesigulane. Oku kuthobela kubini kwandisa ukufikelela kwakho kwimarike kakhulu. Yakha ukuthembana nabasebenzi bezempilo kunye nezigulana kwihlabathi liphela, ibeka imveliso yakho njengenkokeli.
UkuNgena ngaphandle kweNkuthalo ngenxa yePassive Self-Ligating Brackets
Ukuqinisekisa iziQinisekiso zoMvelisi (i-CE Mark, i-FDA 510(k) okanye i-PMA)
Kufuneka uqinisekise iziqinisekiso zomenzi. Ngalo lonke ixesha khangela uphawu lweCE olusebenzayo. Khangela i-FDA 510 (k) imvume okanye i-Pre-Market Approval (PMA). La maxwebhu angqina ukuthotyelwa kwemveliso. Cela izatifikethi ezisemthethweni ngqo kumenzi. Kufuneka uqinisekise ubunyani bazo. Eli nyathelo libalulekileyo lithintela imiba yolawulo yexesha elizayo. Iqinisekisa ukuba imveliso yakho ihlangabezana nemigangatho yokhuseleko ebalulekileyo.
UVavanyo loHlelo lweMveliso yeeBrackets ze-Orthodontic
Kufuneka uqonde ulwahlulo lwemveliso.izibiyeli Orthodonticngokwesiqhelo Class IIa phantsi kwemithetho EU. Ngokuqhelekileyo zizixhobo zeClass II ze-FDA. Olu lwahlulo lumisela iimfuno ezithile zolawulo. Ukwazi iklasi ngqo kukunceda ulungiselele amaxwebhu achanekileyo. Kukwachaphazela uvavanyo oluyimfuneko kunye nezibophelelo zasemva kokuthengisa. Kufuneka uluqinisekise olu hlelo kwangethuba.
Ukuqonda usetyenziso olucetywayo kunye neeMfuno zokuFakwa kweeLebhile
Cacisa ngokucacileyo ukusetyenziswa okucetywayo kweizibiyeli ezizidibanisayo. Le nkcazo ikhokela isicwangciso sakho sokulawula sonke. Kufuneka uphonononge zonke iimfuno zokuleyibhile ngononophelo. Iileyibhile kufuneka ibandakanye ulwazi oluthile. Oku kuhlala kubandakanya iinkcukacha zomenzi, igama lesixhobo, kunye nezilumkiso ezibalulekileyo. Qinisekisa ukuba iilebhile zakho zithobela zombini imithetho ye-CE kunye ne-FDA. Ukuleyibhile okungafanelekanga kunokukhokelela ekulibazisekeni kokungeniswa okanye ukwaliwa.
Iziqinisekiso zoMboneleli kunye nokuqwalaselwa koPhicotho
Kufuneka uvumele ababoneleli bakho ngokupheleleyo. Ukuqhuba uphicotho lwezixhobo zabo zokuvelisa. Vavanya inkqubo yabo yolawulo lomgangatho (QMS). Qinisekisa ukubambelela kwabo kwimigangatho yamazwe ngamazwe efana ne-ISO 13485. I-QMS eyomeleleyo iqinisekisa umgangatho wemveliso ongaguqukiyo. Ubudlelwane obuqinileyo bomthengisi, obakhelwe ekuthembekeni nasekuthobeleni, bubalulekile kwimpumelelo yakho. Oku kukhuthala kunciphisa umngcipheko kwaye kukhusele ishishini lakho.
Uluhlu lokuThobela i-CE lwabaThunyeli bamazwe angaphandle be-Passive Self-Ligating Brackets
Ukukhangela ukuthotyelwa kwe-CE kufuna indlela eyakhiweyo. Kufuneka ufezekise uninzi lwezibophelelo eziphambili njengomntu ongenisa ilizwe ngaphandle kwizibiyeli ezizibophelelayo. Olu luhlu lukhokelela kwinqanaba ngalinye elibalulekileyo.
Ukonyula uMmeli oGunyaziweyo
Kufuneka utyumbe uMmeli oGunyaziweyo (AR) ukuba umenzi wakho ungaphandle kweManyano yaseYurophu. Le AR isebenza njengendawo yoqhagamshelwano yomenzi ngaphakathi kwe-EU. Baqinisekisa ukuthotyelwa kwemigaqo ye-EU. I-AR yakho ijongana nonxibelelwano nabasemagunyeni belizwe. Bakwancedisa nakwimisetyenzana yokucupha emva kokuthengisa. Khetha i-AR enobuchule kwimimiselo yezixhobo zonyango. Olu khetho lubalulekile ekufikeleleni kwimarike egudileyo.
Ingcebiso:Igama loMmeli wakho oGunyaziweyo kunye nedilesi kufuneka ivele kwileyibheli yesixhobo. Oku kuchaza ngokucacileyo iqela elinoxanduva ngaphakathi kwe-EU.
Ukuqinisekisa ukuFumaneka kweSibhengezo sokuThotyelwa kweMithetho (i-DoC)
Kufuneka uqinisekise ukuba i-Declaration of Conformity (DoC) iyafumaneka. Umvelisi ukhupha olu xwebhu. Ichaza ukuba izibiyeli ezizibambelayo zihlangabezana nazo zonke iimfuno ezifanelekileyo ze-EU zempilo nokhuseleko. I-DoC iyaqinisekisa ukuthotyelwa kweUmmiselo wesixhobo soNyango (MDR).Kufuneka ube nekopi yalo DoC. Abasemagunyeni bangayicela nanini na. Qinisekisa ukuba i-DoC yeyangoku kwaye ibandakanya imveliso yakho ethile.
Ukuphonononga uXwebhu lobuGcisa (iFayile yobuGcisa)
Kuya kufuneka uphonononge uXwebhu lobuGcisa bomenzi, okwaziwa ngokuba yiFayile yobuGcisa. Le fayile iqulethe ulwazi oluneenkcukacha malunga nesixhobo. Ibandakanya ukucaciswa koyilo, uvavanyo lomngcipheko, kunye nedatha yovavanyo lweklinikhi. IFayile yoBugcisa ingqina ukhuseleko kunye nokusebenza kwesixhobo. Awudingi ukubamba ifayile yonke. Nangona kunjalo, kufuneka ukwazi ukuyinikezela kwabasemagunyeni xa uyicela. Qonda imixholo yayo ukuze uqinisekise inkuthalo efanelekileyo.
Iimfuneko zokuleyibhile kunye neMiyalelo yokuSetyenziswa (IFU).
Kufuneka uqinisekise ukuba zonke iileyibhile kunye neMiyalelo yokuSetyenziswa (IFU) ithobela iimfuno zeCE. Iileyibhile kufuneka zicace, zifundeke, kwaye zibhalwe ngolwimi lwelungu apho isixhobo sithengiswa khona. Kufuneka babandakanye uphawu lwe-CE, igama lomenzi, idilesi, kunye neenkcukacha ze-AR. I-IFU ibonelela ngolwazi oluyimfuneko kusetyenziso olukhuselekileyo nolufanelekileyo. Kufuneka iinkcukacha zezalathisi, contraindications, izilumkiso, kunye nezilumkiso. Ukuleyibhile okungachanekanga kunokukhokelela ekukhunjulweni kwemveliso.
Nazi izinto eziphambili zokuleyibheli:
- CE uphawu:Kubonakala ngokucacileyo.
- Ulwazi lomvelisi:Igama nedilesi.
- Ummeli ogunyazisiweyo:Igama nedilesi.
- Igama Lesixhobo:Isazisi esicacileyo.
- Iqela/Inombolo yeNqashiso:Ukulandeleka.
- Ulwazi ngoNzala:Ukuba kuyangena.
- Umhla WOKUPHELELWA:Ukuba kuyangena.
- Uchongo lwesiXhobo esiFanelekileyo (UDI):Njengoko kufunwa yi-MDR.
IiMbophelelo zePost-Market Surveillance (PMS).
Unezibophelelo zePost-Market Surveillance (PMS) njengomntu ongenisa impahla ngaphandle. Oku kuthetha ukuba kufuneka ubeke esweni ukusebenza kwesixhobo xa sele sisemarikeni. Kufuneka uxele naziphi na izehlo ezimandundu kwabasemagunyeni abafanelekileyo. Ukwafaka isandla kwingxelo eqhubekayo. Oku kubandakanya ukuqokelela kunye nokuphonononga idatha yokusebenza kwesixhobo. Ukuseka inkqubo yokwamkela nokuqhuba izikhalazo. Ukuthatha inxaxheba kwakho okusebenzayo kwi-PMS kunceda ukuqinisekisa ukhuseleko lwesigulane oluqhubekayo.
Uluhlu lokuThobela i-FDA lwabaThunyeli bangaphandle be-Orthodontic Self Ligating Brackets-passive
Kufuneka ujikeleze i-US Food and Drug Administration (FDA) ngononophelo. Olu luhlu lukhokelela kumanyathelo ayimfuneko okungenisa i-Orthodontic Self Ligating Brackets-passive e-United States.
Ukubhalisa njengoMrhwebi ngaphandle kwe-FDA
Kufuneka ubhalise ukusekwa kwakho kunye ne-FDA. Eli linyathelo elisisinyanzelo. Usebenzisa i-FDA Unified Registration and Listing System (FURLS) kule nkqubo. Olu bhaliso luchonga wena njengomntu ongenisa ngaphandle ngokusemthethweni izixhobo zonyango. Kufuneka uhlaziye olu bhaliso rhoqo ngonyaka. Ukungaphumeleli ukubhalisa kunokukhokelela ekubambezelekeni kwamanye amazwe okanye ukwaliwa kokuthunyelwa kwakho.
Uluhlu lwezixhobo kunye ne-FDA
Kufuneka udwelise izixhobo ezithile ojonge ukuzingenisa ngaphandle kwe-FDA. Le yinkqubo eyahlukileyo kubhaliso lwakho lomrhwebi. Unikezela ngolwazi oluneenkcukacha malunga nodidi ngalunye lwesixhobo. Oku kubandakanya ulwahlulo nokusetyenziswa kwayo. Kwi-Orthodontic Self Ligating Brackets-passive, uya kudwelisa iimodeli ezithile okanye iindidi oceba ukuzizisa kwimarike yase-US. Olu luhlu luqinisekisa ukuba i-FDA iyayazi ukuba zeziphi izixhobo ozingenisayo.
Ukuqinisekisa uBhaliso lokuSekwa koMvelisi kunye noLudwe lweZixhobo
Kufuneka uqinisekise ukuthotyelwa komenzi wakho. Umenzi wangaphandle we-Orthodontic Self Ligating Brackets-passive kufuneka kwakhona abhalise ukusekwa kwakhe kunye ne-FDA. Kufuneka badwelise izixhobo zabo. Awukwazi ukungenisa izixhobo kumvelisi ongabhaliswanga okanye ongafakwanga kuluhlu. Cela ubungqina bobhaliso lwangoku kunye noluhlu. Eli nyathelo libalulekile ekuthobeleni kwakho.
Ukuqonda Ukuthotyelwa kweNkqubo yoBulunga (QSR) (21 CFR Icandelo 820)
Kufuneka uqonde i-Quality System Regulation (QSR). Lo mmiselo ngu-21 CFR Icandelo 820. Uqinisekisa ukuba izixhobo zonyango zikhuselekile. Ikwaqinisekisa ukuba ziyasebenza. I-QSR ibandakanya iindlela, amaziko, kunye nolawulo olusetyenziselwa ukuyila, ukuvelisa, ukupakisha, ukuleyibhela, ukugcina, ukufakela, kunye nokunikezela ngeenkonzo kwizixhobo zonyango. Unoxanduva lokuqinisekisa ukuba umenzi wakho wangaphandle uhambelana ne-QSR. Oku kuquka:
- Ulawulo loYilo:Ukuqinisekisa ukuba uyilo lwesixhobo luyahlangabezana neemfuno zomsebenzisi.
- Ulawulo lweMveliso kunye neNkqubo:Ukugcina umgangatho wemveliso ongaguqukiyo.
- Amanyathelo oLungiso kunye noThintelo (CAPA):Ukujongana nokuthintela imiba yobulunga.
- Uxanduva loLawulo:Ukuqinisekisa ulawulo oluphezulu luxhasa inkqubo yomgangatho.
Phawula:Ngelixa umenzi ephumeza ngokuthe ngqo i-QSR, wena, njengomthumeli-mpahla ngaphandle, unoxanduva lokuqinisekisa ukuba bayabambelela. Kufuneka wenze uphicotho-zincwadi okanye ucele amaxwebhu ukuqinisekisa ukuthotyelwa kwawo.
IiMfuno zokuLeyibhile (21 CFR iSigaba 801)
Kuya kufuneka ulandele iimfuno ezingqongqo zokuleyibheli ze-FDA. Ezi zichazwe ngokweenkcukacha kwi-21 CFR iSigaba 801. Iileyibhile zifuna ulwazi oluthile. Kufuneka babe ngesiNgesi. Qinisekisa ukuba iilebhile zakho ziquka:
- Igama lomenzi kunye nedilesi.
- Igama lesixhobo.
- Usetyenziso olucetywayo.
- Naziphi na izilumkiso okanye amanyathelo okhuseleko afunekayo.
- I-Unique Device Identification (UDI).
- Izalathiso zokusetyenziswa.
Ukuleyibhile okungachanekanga okanye okungaphelelanga kunokubangela ukuba izixhobo zakho zivalelwe emdeni.
Iimbophelelo zeNgxelo yeSixhobo sezoNyango (MDR).
Unezibophelelo zeMedical Device Reporting (MDR). Kufuneka uxele iziganeko ezithile ezimbi kwi-FDA. Oku kuquka:
- Ukufa okunxulumene nesixhobo.
- Ukulimala okukhulu okunxulumene nesixhobo.
- Ukungasebenzi kakuhle kwesixhobo okunokukhokelela ekufeni okanye ukwenzakala okumandundu ukuba kuphinda kwenzeke.
Kufuneka umisele inkqubo yokuqokelela nokungenisa ezi ngxelo. Oku kuqinisekisa ukuba i-FDA ibeka iliso kukhuseleko lwesixhobo ngokufanelekileyo.
IiNkqubo zokuNgena kwamanye amazwe kunye neeNkqubo zokuCoca iZinto
Kufuneka ulandele iinkqubo ezithile zokungeniswa kwempahla evela ngaphandle kunye neenkqubo zokucocwa kwempahla. I-FDA idlala indima yokucoca izixhobo zonyango kumda wase-US. Kufuneka unikeze amaxwebhu afanelekileyo. Oku kubandakanya isaziso sangaphambili sokufika. Kananjalo kufuneka ungenise iifom zokungenela. I-FDA inokuhlola ukuthunyelwa kwakho. Basenokuzivalela izixhobo ukuba bakrokrela ukungathotyelwa. Sebenza ngokusondeleyo nomthengisi wakho wamasiko. Qinisekisa ukuba onke amaphepha ayimfuneko achanekile kwaye aphelele. Oku kunceda ukuphepha ukulibaziseka.
Imigibe eqhelekileyo yokuNgenisa i-Passive Self-Ligating Brackets kunye neNdlela yokuZiphepha
Ujongene nemingeni emininzi eqhelekileyo xa ungenisa izixhobo zonyango. Ukuqonda le migibe kukunceda uphephe iimpazamo ezinkulu. Unokuqinisekisa inkqubo yokungenisa elizweni egudileyo, ethobelayo.
Uxwebhu olungaphelelanga
Uhlala udibana nokulibaziseka ngenxa yamaxwebhu angekhoyo okanye angaphelelanga. Oku kubandakanya Izatifikethi ze-CE, imvume ye-FDAiileta, okanye iifayile zobugcisa. Amagosa eCustoms ayakumisa ukuthunyelwa kwakho ngaphandle kwamaphepha afanelekileyo. Kuya kufuneka uqinisekise ngobuchule onke amaxwebhu afunekayo ngaphambi kokuba iimveliso zakho zithunyelwe.
Ukutolikwa ngendlela engeyiyo kweMigaqo
Usenokutolika ngendlela engeyiyo imigaqo ye-CE okanye ye-FDA. Le mithetho itshintsha rhoqo. Ukungaqondi kakuhle kunokukhokelela ekungathotyelwani. Oku kubangela ukukhunjuzwa kwemveliso okanye ukuvalwa kwemarike. Kufuneka udibane neengcali zolawulo okanye uphonononge rhoqo isikhokelo esisemthethweni.
Ukunqongophala kweNkqubo yokuQapha i-Post-Market
Ubeka emngciphekweni wezohlwayo eziqatha ngaphandle kwenkqubo eyomeleleyo yokugada emva kokuthengisa. Kufuneka ujonge ukusebenza kwesixhobo emva kokuthengisa. Ukungaphumeleli ukuchaza iziganeko ezimbi okanye iintsingiselo zaphula imigaqo. Ukuseka iinkqubo ezicacileyo zokusingatha isikhalazo kunye nokunika ingxelo ngeziganeko.
Ukuleyibhile okungaThotyelwayo okanye i-IFU
Ungajongana nokwaliwa ukuba ilebhile yakho okanye iMiyalelo yokuSetyenziswa (IFU) ayihambelani nemigangatho. Iileyibhile kufuneka iqulathe ulwazi oluthile ngolwimi oluchanekileyo. Kufuneka kwakhona baquke iisimboli ezifunekayo. Ukuleyibhelishwa ngendlela engafanelekanga kukhokelela ekuvalelweni amasiko. Kuya kufuneka uphonononge ngobunono konke ukuleyibhile ngokuchasene neemfuno ze-CE kunye ne-FDA.
Ukukhetha abavelisi abangathembekanga
Ubeka esichengeni umsebenzi wakho wonke ngokusebenzisana nabavelisi abangathembekanga. Abanye abavelisi abanazo iinkqubo ezifanelekileyo zolawulo lomgangatho okanye iziqinisekiso. Oku kukhokelela kwiimveliso ezingekho mgangathweni. Kuya kufuneka wenze inkuthalo egqibeleleyo kunye nophicotho kubo bonke abanokuba ngababoneleli.
IiNdlela eziGqwesileyo zokuThobela iOrthodontic Self Ligating Brackets-passive Regulations
Kufuneka ugcineukuthotyelwa rhoqo.Oku kuqinisekisa ukuba i-Orthodontic Self Ligating Brackets-passive yakho ihlala isemarikeni. Amanyathelo asebenzayo athintela imiba yolawulo yexesha elizayo.
Uhlolo oluQhelekileyo lweeHlaziyo zeMithetho
Kufuneka uhlale unolwazi malunga notshintsho lolawulo. Zombini i-CE kunye nemithetho ye-FDA iyaguquka. Jonga rhoqo izibhengezo ezisemthethweni ze-FDA kunye nohlaziyo lwemithetho ye-EU. Bhalisa kwiileta zeendaba zoshishino. Oku kukunceda ulungelelanise iinkqubo zakho ngokukhawuleza.
Ukugcina iiRekhodi eziBanzi
Kufuneka ugcine iirekhodi ngononophelo. Bhala yonke imiba yenkqubo yakho yokungenisa elizweni. Oku kubandakanya izivumelwano zababoneleli, izibhengezo ezivela kumazwe angaphandle, ukuhlolwa kolawulo lomgangatho, kunye nelogi yezikhalazo. Ezi rekhodi zibalulekile kuphicotho. Babonisa ukubambelela kwakho kwimimiselo.
Ukuseka iinkqubo zangaphakathi zokuthobela imithetho
Kufuneka uphuhlise iinkqubo zokuthotyelwa kwangaphakathi ezicacileyo. Yenza iiNkqubo zokuSebenza eziMgangatho (SOPs) kwinyathelo ngalinye. Oku kubandakanya ukufumana, ukugcinwa, kunye nokuhanjiswa. Iinkqubo ezihambelanayo zinciphisa iimpazamo. Baqinisekisa ukuba bonke abasebenzi balandela izikhokelo zolawulo.
Abasebenzi boQeqesho kwiiMfuno zoLawulo
Kufuneka uqeqeshe abasebenzi bakho ngocoselelo. Bafundise kuzo zonke iimfuno ezifanelekileyo ze-CE kunye ne-FDA. Oku kuquka ukuleyibhile, ukunika ingxelo yesiganeko esibi, kunye nolawulo lomgangatho. Abasebenzi abaqeqeshwe kakuhle banqanda ukungathotyelwa. Bayakuqonda ukubaluleka kokuphatha i-Orthodontic Self Ligating Brackets-passive ngokuchanekileyo.
Ukubandakanya Consultants Regulatory Xa Kuyimfuneko
Kufuneka ucinge ngokuzibandakanya nabacebisi bolawulo. Banikezela ngesikhokelo sobuchule kwimiba entsonkothileyo. Abacebisi banokunceda ukutolika imimiselo emitsha. Bakwancedisa namalungiselelo ophicotho-zincwadi. Ubungcali babo buqinisekisa ukuba isicwangciso sakho sokuthobela sihlala somelele.
Ukujonga izinto ezintsonkothileyo ze-CE kunye nokuthotyelwa kwe-FDA kwizibiyeli ezizidibanisayo ezizibambeleyo kubalulekile ekungeniseni ngempumelelo. Ngokulandela ngenkuthalo olu luhlu lokuhlola lubanzi, unokunciphisa ngempumelelo imingcipheko enokwenzeka. Uqinisekisa ukufikelela kwiimarike ezingenamthungo. Ukwaphakamisa eyona migangatho iphezulu yokhuseleko lwesigulane.
FAQ
Leliphi elona nyathelo lokuqala ekufuneka ulithathe njengomntu othenga kumazwe angaphandle?
Kufuneka uqinisekise iziqinisekiso ze-CE kunye ne-FDA zomenzi. Oku kuqinisekisa ukuthobela imveliso kwasekuqaleni.
Ngaba usoloko ufuna izatifikethi ze-CE kunye ne-FDA?
Ewe, kufuneka zombini ukufikelela kwimarike yehlabathi. I-CE ivumela ukuthengisa eYurophu, kwaye i-FDA ivumela ukuthengisa e-US
Kwenzeka ntoni ukuba uxwebhu lwakho aluphelelanga?
Amagosa eCustoms aya kulibazisa okanye akwale ukuthunyelwa kwakho. Kuya kufuneka uqinisekise ukuba onke amaphepha agqityiwe phambi kokuthunyelwa.
Ixesha leposi: Novemba-11-2025