Imakethi yehlabathi ye-hyaluronic acid esekwe kwi-dermal fillers ixabisa malunga ne-6.7 yeebhiliyoni zeedola ngo-2025 kwaye kuqikelelwa ukuba iza kukhula kwi-CAGR ye-12.4% ukuya kuthi ga kwi-19.2 yeebhiliyoni zeedola ngo-2034. umsasazi wehlabathi jikelele – ukuba ungajonga kumhlaba onzima wolawulo wokungenisa kunye nokuthengisa izihluzi zedermal, ngakumbi kwimarike yaseYurophu.
Isiqinisekiso se-CE sisembindini wolu lawulo lolawulo. Ukuqonda inkqubo yoqinisekiso lwe-CE yezihluzi zedermal ayingombuzo nje wokuthotyelwa kwabasasazo, abanini bekliniki kunye nabaphuhlisi beempawu, lukhuphiswano olunempembelelo ethe ngqo kubuchule bakho bokufumana, ukugcina kunye nokuthengisa ezi mveliso ngokuzithemba.
Yintoni isiQinisekiso se-CE kwaye kutheni ibalulekile kwiiFili zedermal?
Uphawu lwe-CE lusetyenziswa ngabavelisi ukubonisa ukuba iimveliso zabo ziyahlangabezana nazo zonke iimfuno ezibalulekileyo zempilo efanelekileyo yaseYurophu, ukhuseleko kunye nomthetho wokhuseleko lokusingqongileyo. Esi satifikethi se-dermal fillers siphantsi kwe-Medical Devices Regulation (EU) 2017/745 (okt MDR), eye yasebenza ngokupheleleyo ngoMeyi 2021.
Ngaphantsi kwe-MDR, i-dermal fillers ihlelwa njengezixhobo zonyango - nangona zisetyenziselwa kuphela iinjongo zokuthambisa ezifana nokulungiswa kwemibimbi okanye ukwandiswa komlomo. Ngokutsho kwe-EU I-Medical Devices Regulation , zonke izihluzi zedermal ezibekwe kwimarike ye-EU kufuneka zithwale uphawu lwe-CE ukubonisa ukuba zizalisekisa iimfuno ezingqongqo zokhuseleko kunye nokusebenza.
Kubasasazi kunye nabanini bebhrendi, oku kuthetha inyani ebalulekileyo: Ukuba iimveliso zakho zokugcwalisa idermal aziphawulwanga i-CE, azinakubekwa kwintengiso yaseYurophu.
Inkqubo yesiQinisekiso seCE: ISikhokelo seNyathelo-ngenyathelo
Inkqubo yokuqinisekiswa kwe-CE ye-dermal fillers yinkqubo yamanqanaba amaninzi, efuna utyalo-mali olubalulekileyo kwiinkqubo ezisemgangathweni, ubungqina bekliniki kunye nobuchule bokulawula. Inkqubo imi ngolu hlobo lulandelayo:
Inyathelo 1: Hlela imveliso phantsi kwe-MDR
Izihluzi zedermal zidweliswe kwiSihlomelo XVI se-MDR. Esi sihlomelo sichaphazela iimveliso ezingajoliswanga ukuba zibe nenjongo yonyango, kodwa eziziphatha njengezixhobo zonyango kwaye zibeke imingcipheko efanayo. Ukuhlelwa ngokweempawu zemveliso:
● Iifayili zedermal ezifunxayo zithathwa ngokubanzi njengeKlasi III-ingozi enkulu.
● Iimveliso eziqulethe izinto zonyango (umz. i-lidocaine) zithathwa njengemveliso edibeneyo ngokuhambelana neSiqendu 1(8) se-MDR.
Izixhobo zoMgangatho we-III zifuna olona vavanyo lungqongqo lokuthobela, kubandakanywa nezifundo zeklinikhi ezisisinyanzelo eziyilwe zaza zahlelwa ngokufana neSigaba sesi-III solingo lonyango.
Inyathelo lesi-2: Ukusebenzisana neZiko elazisiweyo
Abavelisi boDidi lwe-III lwezihluzi zedermal kufuneka basebenze neZiko elaziswayo elizimeleyo, iqumrhu lovavanyo lokuthobela elichongwe ngabasemagunyeni beManyano yaseYurophu. Ibhodi eyazisiweyo iphonononga amaxwebhu obugcisa bomenzi, inkqubo yolawulo lomgangatho kunye nobungqina bekliniki phambi kokukhupha isatifikethi seCE.
Abavelisi kufuneka bavelise idatha yeklinikhi eyomeleleyo engqina ukhuseleko nokusebenza kwezihluzi zabo zedermal.' Oku kudla ngokubandakanya:
● Uvavanyo lwangaphambi kweklinikhi (i-biocompatibility, ukuqinisekiswa kokuvala inzala, izifundo zobomi beshelufa)
● Izifundo zeklinikhi ebantwini
● Izifundo zolandelelo lwezonyango emva kokwaziswa kweemarike (PMCF)
Inyathelo lesi-4: Isiqinisekiso senkqubo yolawulo lomgangatho
Abavelisi kufuneka baphumeze kwaye bagcine inkqubo yolawulo lomgangatho oqinisekisiweyo-ngokuqhelekileyo i-ISO 13485-egubungela zonke izigaba ukusuka kulawulo loyilo ukuya kwimveliso kunye nokucupha emva kokuthengisa.
Nje ukuba ibhodi eyazisiweyo iqinisekise ukuthotyelwa, umenzi uzoba isiBhengezo se-EU sokuThotyelwa kwaye ancamathisele uphawu lwe-CE kwimveliso. Emva koko imveliso ibhalisiwe kwiDatha yeDatha yaseYurophu kwiZixhobo zezoNyango (EUDAMED) kwaye yabelwa i-Unique Device Identification (UDI).
Kuthetha ukuthini oku kubanini bebrendi kunye nabasasazi
Kuwe njenge Umsasazi wokuzalisa wamazwe ngamazwe , izibophelelo zakho zolawulo zihamba ngaphaya kokukhetha iimveliso ezinesatifikethi se-CE. Phantsi kwe-MDR, abaThuthi baya:
Jonga ukumakishwa kwe-CE kwiimveliso kunye nokuba amaxwebhu afanelekileyo obugcisa kunye nemiyalelo yokusetyenziswa ayafumaneka
● Qinisekisa ukuba iileyibhile ziyahambelana neemfuno zolwimi lwelizwe ekujoliswe kulo
● Gcina iirekhodi zokulandeleka kunye nokubonisa inkuthalo efanelekileyo kwabasemagunyeni abanobuchule
● Iimeko zogcino nezothutho aziyi kuchaphazela ukuthotyelwa kwemveliso
Izibonda ziphezulu kubanini bebhrendi abajonga ileyibhile yabucala okanye izivumelwano zeOEM. Kuya kufuneka uqinisekise ukuba amaqabane akho emveliso anesatifikethi seCE kunye neenkqubo zomgangatho kunye neziseko zolawulo ukuxhasa ukuthotyelwa okuqhubekayo.
Ukufumana uMlingane othembekileyo weSatifikethi seCE
Ayizizo zonke izatifikethi ze-CE ezifanayo. I-Medical Device Directive (MDD) endala ngoku ithathelwe indawo nguMthetho omtsha weMedical Device Regulation (MDR) oneemfuno ezingqongqo. Iimveliso eziqinisekisiweyo phantsi kwenkqubo endala ziya kufuneka zitshintshele kwisatifikethi se-MDR ngaphambi kwe-31 kaDisemba, i-2027 okanye i-2028 (kuxhomekeke kuluhlu lwengozi).
Nazi ezinye zezinto eziphambili ekufuneka uzijonge xa uvavanya abanokuba ngababoneleli:
● Isiqinisekiso esisebenzayo se-MDR CE (ayisosiqinisekiso se-MDD)
● Isiqinisekiso se-ISO 13485 QMS
● Ukwenziwa kwe-GMP (Udidi lwe-100 okanye olungcono)
● Ubungqina bezonyango ukuxhasa amabango okhuseleko nokusebenza
● Amaxwebhu acacileyo olawulo akhoyo xa efunwa
AOMA: Iqabane lakho le-CE-certified dermal filler distribution
Ngaphezulu kweminyaka engama-23, i-AOMA CO., LTD. ube liqabane elithembekileyo labathengisi behlabathi behlabathi, iikliniki zobuhle kunye nabanini beempawu. Sithumela iimveliso zethu kumazwe angaphezu kwe-120 kuquka iManyano yaseYurophu, iUnited States kunye neemarike ezinkulu zaseLatin America, kuMbindi Mpuma naseAsia.
Umgangatho oqinisekisiweyo we-CE onokuthi uyithembe
Zonke iifayili zedermal ze-AOMA zenziwe ngentlonipho epheleleyo kwi-CE kunye nemigangatho yolawulo ye-FDA kwaye ziqinisekiswe kwi-ISO 13485 inkqubo yolawulo lomgangatho. Siyazingca ngokuba Imveliso ye-CE eqinisekisiweyo ye-dermal filler , ehlangabezana neemfuno ezingqongqo ze ULawulo lweZixhobo zoNyango lwe-EU - ukunika wena kunye nabaxhasi bakho ukuzithemba kwinaliti nganye.
Sizibophelele kwi Ukuthotyelwa kwemithetho yokugcwalisa kuyo yonke inkqubo yemveliso, ukusuka ekuhlolweni kwezinto ezikrwada ukuya kwimveliso ye-aseptic ukuya kuvavanyo olugqityiweyo lwemveliso.
Amaziko okuvelisa akumgangatho wehlabathi
Ifektri yethu ithatha indawo ye-4800 square metres, ixhotyiswe ngeklasi yokuqala ye-Class 100 GMP workshop yokuvelisa amayeza, umgangatho ophezulu kwishishini. Isibonelelo sinemizila emithathu yokuvelisa kunye nomthamo wemihla ngemihla yeeyunithi ze-500,000 ze-sodium hyaluronate gel. Isebenzisa izixhobo eziphucukileyo, ezifana ne-INOVA yaseJamani i-high-viscosity pre-filled pre-filled filling machine
Ukuqwalaselwa kweshishini
I-AOMA ingomnye wabenzi be-10 abaphezulu be-hyaluronic acid fillers e-China kwaye uye waphumelela ukulungelelanisa iimveliso kwiimpawu ezingaphezu kwe-580, kunye nezinga lokwaneliseka kwabathengi be-99.5%. Yethu I-ISO-certified Filler factory isebenza kumgangatho we-sigma ezintandathu. Sichitha ngaphezulu kwe-10% yengeniso yethu yonyaka kwi-R&D.
OEM / ODM Amandla
Siyingcali I-HA fillers exporters , ibonelela ngeenkonzo ze-OEM/ODM zonke-kwinye ngeeveki ezi-2-3 kuphela zexesha lokukhokela imveliso. Sineendlela ezingaphezulu kwe-1,000 eziqinisekisiweyo kwaye sibonelela ngokuguquguquka kophawu, ukupakishwa, iifomula kunye nomthamo wokukunceda ukuba wakhe ibhrendi yakho ngelixa ugcina umgangatho kunye nokuthotyelwa kwemithetho.
Ukuqonda iMithetho yokuNgenisa iiFili
Nawuphi na umsasazi ofuna ukukhula abe kwimarike yaseYurophu kufuneka aqonde imimiselo yokungeniswa kwempahla . Iimfuno eziphambili ziquka:
● Uphawu lweCE kufuneka lubonakale lula kwimveliso nakwipakethelo yemveliso.
● Imiyalelo yokusetyenziswa kufuneka ibhalwe ngo(ii)lwimi ezisemthethweni zelizwe ekujoliswe kulo.
● Iimveliso zifuna i-UDI kunye nokubhaliswa kwi-EUDAMED.
● Kuya kusekwa inkqubo yokucupha emva kokuthengisa ukuze kubekwe iliso kwindlela imveliso esebenza ngayo kunye nokuxela iziganeko ezibi.
I-AOMA inikezela ngenkxaso yolawulo oluluqilima kumaqabane ethu okusasaza ngamaxwebhu obugcisa, izatifikethi kunye nesikhokelo sokuthotyelwa kokuqinisekisa ukufikelela kakuhle kwiimarike.
I-Case Study: Ibali leMpumelelo yoMxumi wokwenyani
Ngo-2024, umsasazi eMpuma Yurophu - uthungelwano oluphakathi lweekliniki zobuhle - uqhagamshelane nathi, efuna umthengisi othembekileyo we-CE-certified dermal fillers. Ngaphambili, bebezabalaza nomgangatho wemveliso ongahambelaniyo kunye nokungabikho kwamaphepha olawulo kumenzi wabo wangoku, obeka ishishini labo emngciphekweni.
Babeke iodolo yabo yokuqala yee-HA fillers emva kokuphonononga isatifikethi sethu se-CE, ukuvunywa kwe-ISO 13485 kunye nemigangatho yokwenziwa kwe-GMP. Baye babika ukunyuka kwe-35% yokwaneliseka kwesigulane kunye nokuncipha kwe-28% kwizikhalazo ezinxulumene nemveliso kwiinyanga ze-6. 'Ukungaguquguquki okuphezulu kwebhetshi ukuya kwibhetshi yethu kukhokelele kwiziphumo zonyango ezingcono kakhulu kunye nokuzithemba kwesigulana,' utshilo umlawuli wezonyango wekliniki.
Namhlanje, ngabo kuphela abasasazi kulo mmandla kwaye sisebenza ekudaleni umgca weleyibhile yabucala yothungelwano olukhulayo lweekliniki.
Isiphelo Kutheni kufuneka usibeke phambili iSitifiketi seCE
Ayibobunewunewu, yinto ekufuneka ubenayo kubathengisi bamazwe aphesheya, abanini beempawu kunye nabaqhubi bekliniki abafuna ukungena kwimarike yaseYurophu kwaye baphumelele ukuthenjwa ngabathengi abafunayo. 'Iimveliso ezingaqinisekiswanga ngokungafanelekanga zikuvezela izohlwayo ezilawulayo, umonakalo kwigama kwaye okona kubaluleke kakhulu, imingcipheko kukhuseleko lwesigulana.
Ukukhula okuzinzileyo kweyona marike inomtsalane ye-aesthetics yonyango kwihlabathi inokufezekiswa ngokusebenzisana nabavelisi abanesiqinisekiso se-CE sokugcwaliswa kwedermal, abanezibonelelo zemveliso eziqinisekisiweyo ze-ISO kwaye bayahambelana nemithetho yemveliso. imigangatho yokuthobela ulawulo lokugcwalisa .
