Nguwuphi umahluko phakathi kokuthenga kwi-Everal kunye noMboneleli weeMveliso zezoNyango kunye noMthengisi?

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Nguwuphi umahluko phakathi kokuthenga kwi-Everal kunye noMboneleli weeMveliso zezoNyango kunye noMthengisi?

Xa kuqeshwa impilo kwayeIimveliso zonyango, abathengi bahlala bejamelana nesigqibo esibalulekileyo: nokuba sithenga kumthengisi okanye kumthengisi. Omibini onokukhetha iinzuzo zinezibonelelo zawo, kodwa ukuqonda ukungaboni ngasonye kunokunceda amashishini enze esona sigqibo sihle seemfuno zabo. Ngezantsi, sikhangela izinto eziphambili zahlulahlulo phakathi kokuthenga kwimpilo kwayeUmthengisi weeMveliso zoNyangoNgokuchasene nolunye ugqithiso, izinto ezibonisa izinto ezifana noluhlu lwemveliso, ukuzaliseka, ukuqinisekiswa komgangatho, kunye neenkonzo zenkxaso.

Umthengisi we-oxhorutor

 

I-1. Uluhlu lwemveliso kunye nobuchule

 

Umthengisi:

Abathengisi bezempilo kunye nezonyango abathengisi bangabavelisi okanye banxulumana ngokusondeleyo nomxokelelwane wemveliso. Banikezela ngoluhlu olubanzi lweemveliso ezizodwa ezenzelwe ukuhlangabezana neemfuno zonyango ezithile. Aba bathengisi bahlala benolwazi olunzulu lweemveliso abazithengisayo kunye nokubonelela izisombululo ezikhethiweyo ezilungiselelwe oochwephesha bezempilo. Ababoneleli njengeQela leQela leShanghai babonelela ngemveliso ebanzi yemveliso esukaIzixhobo zokungena ze-vascular, Izirinjisi ezinokuchitheka, IV CathetersIzixhobo zokuqokelela igazi, zonke zihlangabezana nemilinganiselo engqongqo eyimfuneko kwishishini lezonyango. Ngokuthengwa ngokuthe ngqo kumthengisi, abathengi bahlala befumana ukufikelela kwimveliso ekhethekileyo okanye enzima yokufumana.

 

IPHEPHA:

Ngokwahlukileyo koko, abathengisi basebenza njengabathengisi phakathi kwabavelisi kunye nabathengi. Banika i-spectrium ebanzi yeemveliso, kubandakanya abo bangaphandle kwecandelo lezonyango, kwaye bagxile ekuthengeni kokuthenga kakhulu. Ngelixa babonelela ngeentlobo, abathengisi bangahlali bangaphili bephethe iimveliso zonyango ezifuna ubungcali obuthile bobuchwephesha. Ugxininiso lwabo lungaphezulu kwivolumu, kwaye basenokungabi nenqanaba elifanayo lokuqonda malunga nezicelo zemveliso njengabathengisi abakhethekileyo.

 

2. Ukuzaliswa ngokwezifiso kunye nokuguquguquka

 

Umthengisi:

Ababoneleli ngezonyango bathanda ukubonelela ngeendlela zokhetho zezezifundo kuba besebenza ngokusondeleyo nabavelisi okanye abavelisi ngokwabo. Umzekelo, iQela leQela leShanghai linokubonelela i-oem (i-OMBINA YOKUGQIBELA) kunye ne-ODM (evumela ukuba abathengi ba-odolo be-odolo bezenziweyo ngokwezidingo zabo, kuquka ukucaciswa kwemveliso. Abathengisi banokuziqhelanisa neemfuno ezahlukeneyo, abasebenzisa iindlela eziguquguqukayo ezinjengezixhobo zezonyango ezakhayo okanye iinguqulelo eziguqulweyo zeemveliso ezikhoyo zokuhlangabezana nemigangatho ethile yecandelo.

 

IPHEPHA:

Abathengisi abaqhelekileyo abaniki ngqiqweni. Imodeli yabo yeshishini igxile ekuthengiseni izinto eziphathwayo, ezisemgangathweni ezisemgangathweni eziphezulu. Ukuba umthengi ufuna imigaqo ekhethekileyo yemveliso, basenokungakwazi ukuhlalisa ezi zicelo. Eyona njongo iphambili yeHlabathi kukuhambisa uluhlu ngokukhawuleza, okuthetha ukuba abathengi banokuzamkela into esitokhweni, ngamathuba alinganiselweyo ukuguqula okanye ukuhlengahlengisa iimveliso.

 

3. Ukuqinisekiswa komgangatho kunye nezatifikethi

 

Umthengisi:

Umgangatho ubaluleke kakhulu xa uthenge iimveliso zonyango. Abaxhasi njengeqela leqela leqela leqela leqela le-shanghai bahlala bebonelela ngeemveliso ezihlangabezana nemigangatho yoKhuseleko neMigangatho yeHlabathi, efana ne-E, iSO13485, kunye nokuvunywa kwe-FDA. Ezi ziqinisekiso zibalulekile ekuqinisekiseni ukuba iimveliso zihlangabezana neemfuno zolawulo, ezibaluleke kakhulu kubathengi ezisebenza kwiimarike zehlabathi. Abathengisi bahlala benemisebenzi yokulawula umgangatho ngokungqongqo kwaye banike amaxwebhu apheleleyo, aqinisekisa ukuba umthengi ufumana iimveliso ezisemgangathweni eziphezulu, ezithobelayo.

 

IPHEPHA:

Ngelixa abathengisi abaninzi bajongana neemveliso eziqinisekisiweyo, banokuhlala benikezela ngenqanaba elifanayo lokungafihli okanye ukufikelela ngokuthe ngqo kwiinkqubo zokulawula umgangatho. Abathengisi bathenga kwimithombo emininzi, enokwenza kube nzima kubo ukuqinisekisa umgangatho ofanayo kuzo zonke iimveliso. Ukongeza, basenokungasoloko benazo izinto ezifunekayo zokuthumela ngaphandle izixhobo zonyango ezithunyelwa ngaphandle, kuxhomekeka kubathengisi babo. Abathengi kufuneka bakhuthalele xa bethenga iimveliso zonyango kubathengisi bokuqinisekisa ukuba bayayifezekisile imigangatho eyimfuneko yokusetyenziswa kwezempilo.

 

I-4. Inkonzo yentengiso yasemva kwenkxaso kunye nenkxaso

 

Umthengisi:

Xa ukuthenga kumthengisi, ngakumbi inkxaso ekhethekileyo, inkxaso yentengiso yasemva kokuthengisa idla ngokugqibeleleyo. Abaxhasi njengeqela leqela leqela leqela leqela leqela leqela eliqhubekayo labathengi, ukuqinisekisa ukuba abathengi banokuxhomekeka kuyo nayiphi na imibuzo enxulumene nemveliso okanye imiba enxulumene nemveliso okanye imiba. Ezi nkonzo zinokubandakanya uncedo lobuchwephesha, uqeqesho lwemveliso, kunye nesikhokelo ekusebenziseni imveliso. Ukongeza, abathengisi bathanda ukubonelela ngendlela eyakhekani, ukuseka ubudlelwane bexesha elide nabathengi babo ukubonelela ngenkxaso engaguqukiyo.

 

IPHEPHA:

Ngokwahlukileyo, abathengisi badla ngokugxila ekuthengiseni imithamo emikhulu yeemveliso ngokugxininisa okuncinci kwinkxaso yokuthenga emva kweposi. Ngelixa abanye abathengisi banokubonelela ngenkonzo yabathengi, isenokungabi nako ukukodwa okanye ukuphendula njengabanini ababoneleli. Bahlala abanalo ulwazi lobugcisa ukubonelela ngoncedo olunzulu, kwaye eyona nto iphambili kuyo kukuhambisa isitokhwe kunokuba sinike inkxaso eqhubekayo.

 

Ukuqukumbela

 

Isigqibo phakathi kokuthenga i-Probersied evela kwimpilo yezempilo kunye nezonyango ngokuchasene nomthengisi ixhomekeke kakhulu kwiimfuno ezithile zomthengi. Amashishini afuna iimveliso ezikhethekileyo, iinketho zokwenza ngokweziko, imigangatho ebonakalayo ebonakalayo, kunye nenkxaso yentengiso yasemva kokuthengisa, ukuthenga ngqo kumthengisi weQela leQela leShanghai luluhlu olufanelekileyo. Njengomthengisi oqeqeshiweyoizixhobo zonyango, IQela leQela leShanghai libonelela ngesisombululo esimiselweyo kunye neemveliso ezingowe-CE, ISO13485, kunye ne-FDA yamkelwe, iqinisekisa umgangatho kunye nokuthotyelwa kwiimarike zehlabathi. Kwelinye icala, abathengisi banokulunga ngakumbi kubathengi bekhangela iimveliso ezifana ne-bulpic nge-bulk ngokugxila kancinci kwimveliso yemveliso okanye kwiimfuno ezithile zeshishini.

 

Isishwankathelo, xa kufikwa kwimpilo kunye neemveliso zonyango, ukukhetha umthombo olungileyo kunokuba nefuthe elibonakalayo kumgangatho kunye nokuthembeka kweemveliso ezithengiweyo, kunye namava okuthenga.


I-Post Time: Sep-18 ukuya kwi-2024