Iipleyiti zokutshixa zidlala indima ebalulekileyo ekulungiseni i-fracture kunye nokwakhiwa kwakhona kwamathambo. Kule minyaka ilishumi idlulileyo, ishishini lokuvelisa ipleyiti lokutshixa laseTshayina liye lenza inguqu ephawulekayo-ukusuka ekuxeliseni ukuya kwizinto ezintsha, ukusuka kumatshini oqhelekileyo ukuya kubunjineli obuchanekileyo. Namhlanje, abavelisi baseTshayina bavela njengabanikezeli behlabathi abomeleleyo abaziwayo ngokusungula kwabo ubuchwephesha, ukusebenza kakuhle kweendleko, kunye nokuthobela imigangatho yomgangatho wamazwe ngamazwe.
Uphuculo lweTekhnoloji ekuVelweni kwePleyiti yokuTshixa
Ishishini laseTshayina lokufakelwa kwamathambo libone umtsi omkhulu kubugcisa bokuvelisa. Abavelisi bale mihla ngoku bamkela oomatshini beCNC abakwinqanaba eliphezulu, ukubunjwa okuchanekileyo, kunye neenkqubo zokupolisha ezizenzekelayo, ezivumela ulawulo oluchanekileyo malunga nokulungelelaniswa komngxuma, ukuhambelana kwesikrufu, kunye ne-anatomical contouring.
Izixhobo zokucoca ezenziwe nge-Swiss-ezenziwe, ekuqaleni ziyilelwe ukwenziwa kweewotshi, ngoku zisetyenziswa ngokubanzi kwimveliso yepleyiti yamathambo. Oku kuqinisekisa ukuchaneka kwenqanaba le-micron, iindawo ezigudileyo, kunye nokuphindaphinda okugqwesileyo - kubalulekile ekuqinisekiseni ukuzinza kunye nobomi obude beenkqubo zokutshixa iipleyiti.
Ukuveliswa kwezinto ezintsha yenye indawo ephambili. Abavelisi baye batshintshela kwi-alloys ye-titanium yodidi lwezonyango kunye ne-low-modulus stainless steel, enika amandla omatshini aphezulu, i-biocompatibility, kunye nokumelana nokudinwa. Ukongeza, unyango olungaphezulu olufana ne-anodizing kunye ne-passivation luphucula ukuxhathisa kwe-corrosion kunye nokuhambelana kwezicubu.
Abavelisi baseTshayina baqhubele phambili kuyilo lwesiko lwe-anatomical. Ingaba i-T-shaped, i-L-shaped, okanye i-contoured bone plates, iimveliso ngoku zinokuthi zilungelelaniswe kwimimandla ethile yotyando okanye iimfuno zeklinikhi. Le ndibaniselwano yobunjineli obuchanekileyo kunye nokuguquguquka koyilo kuvumela iipleyiti zokutshixa zaseTshayina ukuba zihlangabezane nemigangatho yamazwe ngamazwe kwaye zikhuphisane ngokufanelekileyo kwiimarike zehlabathi.
Iziqinisekiso zamazwe ngamazwe: CE kunye ne-FDA
Kwiimveliso zamathambo ezingena kwimarike yehlabathi, isiqinisekiso solawulo sibalulekile. Abavelisi baseTshayina baye bafumana i-CE, i-FDA, kunye ne-ISO 13485 iziqinisekiso, ezibonisa ukuthotyelwa komgangatho wamazwe ngamazwe kunye nemigangatho yokhuseleko.
Isiqinisekiso seCE (EU MDR)
Ngaphantsi kweEuropean Medical Device Regulation (MDR 2017/745), iipleyiti zokutshixa kufuneka zidlule iimvavanyo ezingqongqo zokuthobela uyilo, izixhobo, ulawulo lomngcipheko, kunye novavanyo lweklinikhi. Abavelisi abaninzi baseTshayina baye bahlangabezana ngempumelelo nezi mfuno, besenza iimveliso zabo ukuba zifanele ukuthengiswa kwi-EU iphela kunye nezinye iimarike ezivunyiweyo ze-CE.
I-FDA 510(k) Usulelo (eUnited States)
Iinkampani ezininzi zaseTshayina ziphumeze i-FDA 510(k) imvume, ebonisa ukulingana okukhulu kwizixhobo zepredicate esele zikwimarike yase-US. Ezi mvume zibonisa ukukhula kobugcisa obukhulayo kunye namandla amaxwebhu abavelisi bamathambo baseTshayina.
Kubathengi behlabathi, ukukhetha umthengisi kunye nezatifikethi ze-CE kunye ne-FDA ziqinisekisa ukuzithemba okulawulwayo, ukulandelwa, kunye nokufikelela kwimarike.
Iindleko-zokusebenza okuluncedo kwabavelisi baseTshayina
Esinye sezona zizathu zinamandla abathengi bakhetha iipleyiti zokutshixa ezivela eTshayina lumlinganiselo okhethekileyo weendleko zokusebenza.
Ixabiso eliphantsi lokuvelisa, ukuchaneka okuphezulu: Ngenxa yokuzenzekelayo, umsebenzi osebenzayo, kunye neentambo ezidibeneyo zokubonelela, iiplate zokutshixa ezenziwe ngamaTshayina zinokubiza i-30-50% ngaphantsi kweemveliso zaseYurophu okanye zase-US ezifaniswayo, ngaphandle kokunciphisa umgangatho.
Umthamo wemveliso onokunyuka: Amaziko amakhulu avumela ukulawulwa komgangatho ongaguqukiyo kunye namaxesha amafutshane okukhokela. Abavelisi abaninzi banokuzalisekisa zombini ii-odolo ze-OEM ezincinci kunye nemveliso yobuninzi kwizibhedlele okanye abasasazi.
Ukuguquguquka kokwenziwa ngokwezifiso: Ababoneleli baseTshayina baziwa ngokukwazi ukuvelisa uyilo olulungelelanisiweyo kunye nobungakanani obuncinci bokuodola (MOQs), enikezela ukuguquguquka okukhulu kubasasazi okanye iiklinikhi ezikhethekileyo.
Amava anamandla okuthumela ngaphandle: Ngeemveliso ezithunyelwa kumazwe angaphezu kwama-50, iinkampani zaseTshayina zinolwazi oluphangaleleyo kulungiselelo lwamazwe ngamazwe, amaxwebhu, kunye neenkqubo zesithethe, ziqinisekisa intsebenziswano engenamagingxi-gingxi namaqabane aphesheya kweelwandle.
Ngenxa yoko, amaqela okuthengwa kwempahla yehlabathi afumana iipleyiti zokutshixa zaseTshayina zibe yibhalansi ehlakaniphile yomgangatho, ukusebenza, kunye nokufikeleleka-ingakumbi ezifanelekileyo kwiimarike ezifuna ukuthembeka kunye nokusebenza kakuhle kweendleko.
Ukwandiswa kokwamkelwa kooGqirha baphesheya kweelwandle
Kwiminyaka elishumi eyadlulayo, abanye oogqirha botyando babethandabuza ukusebenzisa izifakelo ezenziwe eTshayina ngenxa yeenkxalabo malunga nokuthembeka kwexesha elide okanye izikhewu zezatifiketi. Loo mbono itshintshe kakhulu.
I-1.Ukuphuculwa kokusebenza kweklinikhi: Ngezixhobo eziphuculweyo kunye nomatshini ochanekileyo, amandla oomatshini kunye nokulingana kwe-anatomical yeepleyiti zokutshixa zaseTshayina ngoku zikhuphisana nezo zivela kwiimpawu zaseNtshona.
I-2.Impendulo encomekayo evela kubasebenzisi behlabathi jikelele: Abaninzi abasasazo bamazwe ngamazwe babika ukuba emva kokutshintshela kubathengisi baseTshayina, impendulo yokusebenza evela kwizibhedlele kunye noogqirha baye baneliseka kakhulu, kungekho mmahluko obalulekileyo xa kuthelekiswa nezixhobo zaseYurophu.
I-3.I-R&D edibeneyo kunye nenkxaso yobugcisa: Abavelisi baseTshayina babandakanyeka ngakumbi kuphuhliso oluhlangeneyo kunye namaqabane aphesheya, banikezela ngezikhokelo zobuchule botyando, uqeqesho lwemveliso, kunye nenkxaso kwisiza - ukwakha ukuthembana okuqinileyo kunye nobudlelwane bexesha elide.
I-4.Ukuqaphela ngokusebenzisa iziqinisekiso kunye neenkomfa: Ukuthatha inxaxheba kwimiboniso yezokwelapha yehlabathi efana ne-MEDICA kunye ne-AAOS iye yanda ngakumbi ukubonakala kunye nokuthembeka phakathi kweengcali ze-orthopedic emhlabeni jikelele.
Njengoko amatyathanga obonelelo lwehlabathi ahlukana, "Yenziwe eTshayina" iipleyiti zokutshixa azisajongwa njengezinye iindlela ezikumgangatho ophantsi kodwa njengezisombululo ezithembekileyo, eziqinisekisiweyo neziphucukileyo ezithenjwe ngoogqirha baseAsia, eYurophu naseMelika.
Amandla ethu njengeUkutshixa uMvelisi wepleyiti eTshayina
Njengomenzi wepleyiti yokutshixa kunye nomthengisi, inkampani yethu izakhele igama elomeleleyo esekwe kubuchwephesha, ukuchaneka, kunye nokuthembeka.
Ubuchwephesha obusekiweyo - Kwiminyaka yamava kwimveliso ye-orthopedic implant, siye saphuhlisa i-R&D kunye nezakhono zobunjineli eziqhuba ngokuqhubekayo.
Izixhobo ezichanekileyo ze-Swiss-level - Izixhobo zethu zokuvelisa zisebenzisa iinkqubo ze-machining ezenziwe eSwitzerland, ekuqaleni ezenzelwe ukwenziwa kweewotshi ezichanekileyo, ukuqinisekisa ukuchaneka okungafaniyo kunye nokuhambelana kuyo yonke iplate esiyivelisayo.
Ukwenza ngokwezifiso kunye nokuguquguquka - Sinikezela ngoluhlu olubanzi lweentlobo zeplate yokutshixa - ngokuthe ngqo, i-T-shape, i-L-shape, kunye ne-anatomical plates - kunye nenkxaso yoyilo olucwangcisiweyo olusekelwe kwiimfuno ezithile zeklinikhi okanye zengingqi.
Ukuveliswa kwe-scalable - Sisebenza ngomgca wokuvelisa odibeneyo, ukusuka ekuqhutyweni kwezinto eziluhlaza ukuya ekuhlolweni komgangatho kunye nokupakishwa, ukuxhasa ii-odolo ezinkulu kunye namaxesha amafutshane.
Inkqubo ebanzi yomgangatho - Ukwenziwa kwethu kulandela imigangatho engqongqo yamazwe ngamazwe kunye neenkqubo zolawulo lomgangatho (ISO 13485, CE, ukuthotyelwa kwe-FDA), iqinisekisa ukulungela imarike yehlabathi.
Inkonzo ejolise kubathengi -Ngaphaya kwemveliso, sibonelela ngenkxaso yobugcisa, amaxwebhu emveliso, kunye nokulungelelaniswa kwempahla ukunceda abasasazi kunye nezibhedlele ukuba zazise iimveliso zethu ngaphandle kwamagingxigingxi.
Ukuqukumbela
Umzi-mveliso waseTshayina wokwenza iipleyiti zokutshixa uhamba ngokukhawuleza ukuchaneka okuphezulu, umgangatho oqinisekisiweyo, kunye nokuthenjwa kwamanye amazwe. Ngobuchwephesha obuphezulu, imvume ye-CE/FDA, kunye nenzuzo eyomeleleyo yeendleko, ababoneleli baseTshayina balungisa ngokutsha imbonakalo yelizwe lamathambo.
Njengomnye wabenzi beepleyiti zokutshixa ezisekiweyo e-China, sinebhongo lokudibanisa ukuchaneka kwenqanaba laseSwitzerland, ubuchule bokuyila ngokwesiko, kunye nomthamo wemveliso onobungozi ukuzisa izisombululo ezithembekileyo kwiingcali zamathambo zehlabathi.
Ixesha lokuposa: Nov-04-2025