Imakethe yomhlaba wonke yama-hyaluronic acid based dermal fillers ibiza cishe izigidigidi ezi-6.7 zamarandi ngo-2025 futhi kulindeleke ukuthi ikhule ku-CAGR ka-12.4% ukuze ifinyelele cishe ku- $ 19.2 billion ngo-2034. Leli yithuba elihle kakhulu umsabalalisi we-filler wamazwe ngamazwe - uma ungakwazi ukuzulazula endaweni eyinkimbinkimbi yokulawula yokungenisa nokuthengisa izigcwalisi zesikhumba, ikakhulukazi emakethe yaseYurophu.
Isitifiketi se-CE sisenhliziyweni yalo mbuso wokulawula. Ukuqonda inqubo yesitifiketi se-CE sezigcwalisi ze-dermal akuwona nje umbuzo wokuthotshelwa kwabasabalalisi, abanikazi bemitholampilo nabathuthukisi bomkhiqizo, kuyinzuzo yokuncintisana enomthelela oqondile emandleni akho okuthola, ukugcina nokuthengisa le mikhiqizo ngokuzethemba.
Siyini Isitifiketi Se-CE Futhi Kungani Kubalulekile Kuma-Dermal Filler?
Umaki we-CE usetshenziswa abakhiqizi ukukhombisa ukuthi imikhiqizo yabo ihlangabezana nazo zonke izidingo ezibalulekile zomthetho ofanelekile wase-Europe wezempilo, ukuphepha kanye nokuvikelwa kwemvelo. Lesi sitifiketi se-dermal fillers singaphansi kwe-Medical Devices Regulation (EU) 2017/745 (okungukuthi i-MDR), eqale ukusebenza ngokugcwele ngoMeyi 2021.
Ngaphansi kwe-MDR, ama-dermal fillers ahlukaniswa njengemishini yezokwelapha - ngisho nalapho esetshenziselwa izinjongo zezimonyo kuphela njengokulungisa imibimbi noma ukukhulisa izindebe. Ngokusho kwe-EU I-Medical Devices Regulation , wonke ama-dermal fillers abekwe emakethe ye-EU kumele abe nophawu lwe-CE ukukhombisa ukuthi agcwalisa izidingo eziqinile zokuphepha nokusebenza.
Kubasabalalisi nabanikazi bomkhiqizo, lokhu kusho iqiniso elibalulekile: Uma imikhiqizo yakho yokugcwalisa i-dermal ingamakiwe i-CE, ayikwazi ukubekwa emakethe eYurophu.
Inqubo yesitifiketi se-CE: Umhlahlandlela wesinyathelo ngesinyathelo
Inqubo yesitifiketi se-CE yama-dermal fillers iyinqubo enezigaba eziningi, edinga ukutshalwa kwezimali okubalulekile ezinhlelweni zekhwalithi, ubufakazi bomtholampilo kanye nobungcweti bokulawula. Inqubo imi kanje:
Isinyathelo 1: Hlela umkhiqizo ngaphansi kwe-MDR
Ama-dermal fillers abhalwe ku-Annex XVI ye-MDR. Lesi sengezo siphathelene nemikhiqizo engahloselwe ukuba nenjongo yezokwelapha, kodwa eziphatha njengemishini yezokwelapha futhi edala izingozi ezifanayo. Ukuhlukaniswa ngezimpawu zomkhiqizo:
● Izigcwalisi zesikhumba ezimunwayo ngokuvamile zibhekwa njengeSigaba III—ingozi enkulu kakhulu.
● Imikhiqizo equkethe izinto zokwelapha (isb. i-lidocaine) ithathwa njengenhlanganisela yemikhiqizo ngokuvumelana neSigaba 1(8) se-MDR.
Amadivayisi eSigaba III adinga ukuhlolwa kokuvumelana okuqinile, okuhlanganisa izifundo zomtholampilo eziyisibopho eziklanywe futhi zafakwa ngendlela efanayo neSigaba III sokuhlolwa kwemithi.
Isinyathelo sesi-2: Ukusebenzisana Nomzimba Owazisiwe
Abakhiqizi be-Class III dermal fillers kufanele basebenze ne-Notised Body ezimele, indikimba yokuhlola ukuhambisana eqokwe iziphathimandla ze-European Union. I-No Notified Body ibuyekeza imibhalo yezobuchwepheshe yomkhiqizi, uhlelo lokuphatha ikhwalithi nobufakazi bomtholampilo ngaphambi kokukhipha isitifiketi se-CE.
Abakhiqizi badinga ukukhiqiza idatha yomtholampilo eqinile efakazela ukuphepha nokusebenza kwezihlungi zabo zesikhumba.' Lokhu ngokuvamile kuhilela:
● Ukuhlolwa kwangaphambilini (i-biocompatibility, ukuqinisekiswa kokuvalwa inzalo, izifundo zempilo yeshelufu)
● Izifundo zomtholampilo kubantu
● Ucwaningo lokulandelela umtholampilo ngemva kokwethulwa kwemakethe (PMCF)
Isinyathelo sesi-4: Ukuqinisekiswa kohlelo lokuphatha ikhwalithi
Abakhiqizi kumele basebenzise futhi bagcine uhlelo lokuphatha ikhwalithi oluqinisekisiwe—imvamisa i-ISO 13485—ehlanganisa zonke izigaba ukusuka ekulawuleni ukwakheka kuya ekukhiqizeni nasekugadweni kwangemuva kwemakethe.
Uma indikimba eyazisiwe isiqinisekisile ukuthobela umthetho, umenzi udweba Isimemezelo Se-EU Sokuhambisana futhi anamathisele umaki we-CE emkhiqizweni. Umkhiqizo ube usubhaliswa ku-European Database on Medical Devices (EUDAMED) futhi unikezwe i-Unique Device Identification (UDI).
Kusho ukuthini lokhu kubanikazi bomkhiqizo nabasabalalisi
Okwakho njenge Umsabalalisi we-filler wamazwe omhlaba , izibopho zakho zokulawula zidlula ukukhetha nje imikhiqizo enesitifiketi se-CE. Ngaphansi kwe-MDR, Abasabalalisi kufanele:
Hlola ukumakwa kwe-CE emikhiqizweni nokuthi imibhalo yezobuchwepheshe efanele nemiyalo yokusetshenziswa iyatholakala
● Qinisekisa ukuthi ukulebula kuhambisana nezidingo zolimi zezwe okuqondiswe kulo
● Gcina amarekhodi okulandeleka futhi ubonise ukukhuthala okufanele kuziphathimandla ezinekhono
● Izimo zesitoreji nezokuthutha angeke zithinte ukuthotshelwa komkhiqizo
Izibalo ziphakeme kubanikazi bomkhiqizo ababheke ilebula yangasese noma amadili e-OEM. Kufanele uqinisekise ukuthi ozakwethu bokukhiqiza banezitifiketi ze-CE kanye nezinhlelo zekhwalithi nengqalasizinda yokulawula ukusekela ukuthobela umthetho okuqhubekayo.
Ukuthola Uzakwethu Othenjwayo Wokunikeza Isitifiketi
Akuzona zonke izitifiketi ze-CE ezifanayo. I-Medical Device Directive (MDD) manje isithathelwe indawo yiMedical Device Regulation (MDR) enezidingo eziqine kakhulu. Imikhiqizo egunyazwe ngaphansi kwesistimu endala kuzomele idlulele ekunikezweni isitifiketi kwe-MDR ngaphambi komhla ka-December 31, 2027 noma 2028 (ngokuya ngokuhlukaniswa kwengcuphe).
Nazi ezinye zezinto ezibalulekile okufanele uzibheke lapho uhlola abangaba abahlinzeki-mpahla:
● Isitifiketi esisebenzayo se-MDR CE (hhayi isitifiketi se-MDD)
● Isitifiketi se-ISO 13485 QMS
● Ukukhiqizwa kwe-GMP (Ikilasi le-100 noma elingcono)
● Ubufakazi bomtholampilo obusekela izicelo zokuphepha nokusebenza
● Sula amadokhumenti okulawula atholakalayo uma kudingeka
AOMA: Uzakwethu wokusabalalisa isigcwalisi sedermal esiqinisekisiwe yi-CE
Iminyaka engaphezu kwengu-23, i-AOMA CO., LTD. ube nguzakwethu othembekile wabasabalalisi be-filler bamazwe ngamazwe, imitholampilo yobuhle kanye nabanikazi bemikhiqizo. Sithumela imikhiqizo yethu emazweni angaphezu kuka-120 kuhlanganise ne-European Union, i-United States kanye nezimakethe ezinkulu zaseLatin America, Middle East nase-Asia.
Ikhwalithi Eqinisekisiwe ye-CE Ongayethemba
Wonke ama-AOMA dermal fillers akhiqizwa ngenhlonipho egcwele kumazinga okulawula we-CE kanye ne-FDA futhi agunyazwe ohlelweni lokuphathwa kwekhwalithi ye-ISO 13485. Siyaziqhenya ngokuba Imikhiqizo yokugcwalisa i-dermal eqinisekisiwe ye-CE , ehlangabezana nezidingo eziqinile ze- I-EU Medical Devices Regulation - ukunika wena kanye namakhasimende akho ukuzethemba kumjovo ngamunye.
Sizibophezele kukho ukuthobela imithetho yokugcwalisa kuyo yonke inqubo yokukhiqiza, kusukela ekuhlolweni kwezinto ezingavuthiwe kuya ekukhiqizweni kwe-aseptic kuya ekuhlolweni komkhiqizo ophelile.
Izikhungo zokukhiqiza ezisezingeni lomhlaba
Ifektri yethu ithatha indawo engamamitha-skwele angu-4800, ifakwe umhlangano wokusebenzela wokukhiqiza imithi we-Class 100 GMP wesigaba sokuqala, okuyizinga eliphezulu kakhulu embonini. Lesi sikhungo sinemigqa emithathu yokukhiqiza enekhono lansuku zonke lamayunithi angama-500,000 wejeli ye-sodium hyaluronate. Isebenzisa imishini ethuthukisiwe, efana nemishini yaseJalimane yokugcwalisa isirinji ephezulu ye-viscosity egcwele i-viscosity kanye ne-GETINGE yaseSweden ehlala icindezela izibulala-magciwane zokushisa okumanzi, ukuze kuqinisekiswe ukuvumelana kanye nekhwalithi ekukhiqizeni okukhulu.
Ukuqashelwa Kwezimboni
I-AOMA ingomunye wabakhiqizi abaphezulu abayi-10 bezigcwalisi ze-hyaluronic acid e-China futhi yenze ngempumelelo imikhiqizo ibe ngokwezifiso zemikhiqizo engaphezu kuka-580, ngesilinganiso sokwaneliseka kwamakhasimende esingu-99.5%. Eyethu Ifekthri ye-ISO-certified Filler isebenza kumazinga ekhwalithi ayisithupha-sigma. Sichitha ngaphezu kuka-10% wenzuzo yethu yonyaka ku-R&D.
Ikhono le-OEM/ODM
Singochwepheshe I-HA fillers exporters , ihlinzeka ngezinsizakalo ze-OEM/ODM zonke-in-one ezinesikhathi sokuhola sokukhiqiza samasonto angama-2-3 kuphela. Sinamafomula afakazelwe angaphezu kuka-1,000 futhi sinikeza ukwenza ngokwezifiso okuguquguqukayo kophawu, ukupakishwa, amafomula namavolumu ukukusiza ukuthi wakhe owakho umkhiqizo ngenkathi ugcina ukuthotshelwa kwekhwalithi nokulawula.
Ukuqonda Imithetho Yokungenisa Izigcwalisi
Noma yimuphi umsabalalisi ofuna ukukhulela emakethe yaseYurophu udinga ukuqonda imithetho yokungenisa yokugcwalisa . Izimfuneko ezinkulu zihlanganisa:
● Uphawu lwe-CE kufanele lubonakale kalula emkhiqizo nasephaketheni lomkhiqizo.
● Imiyalo yokusetshenziswa kufanele ibe nge(izi)limi ezisemthethweni zezwe okuqondiwe kulo.
● Imikhiqizo idinga i-UDI nokubhaliswa ku-EUDAMED.
● Kuzosungulwa uhlelo lokuqapha ngemuva kwemakethe ukuze kuqashwe ukusebenza komkhiqizo futhi kubike izehlakalo ezimbi.
I-AOMA inikeza ukwesekwa okuqinile kokulawula kozakwethu bokusabalalisa ngemibhalo yobuchwepheshe, izitifiketi kanye nesiqondiso sokuthobela ukuze kuqinisekiswe ukufinyeleleka kwemakethe okushelelayo.
Indaba Eyisibonelo: Indaba Yempumelelo Yekhasimende Langempela
Ngo-2024, umsabalalisi waseMpumalanga Yurophu - inethiwekhi ephakathi nendawo yemitholampilo yobuhle - wasithinta, efuna umphakeli onokwethenjelwa wama-dermal fillers aqinisekiswe yi-CE. Ngaphambilini, babezabalaze ngekhwalithi yomkhiqizo engahambisani kanye nokuntuleka kwamaphepha okulawula avela kumkhiqizi wabo wamanje, okubeka ibhizinisi labo engozini.
Bafake i-oda labo lokuqala lama-HA fillers ngemuva kokubuyekeza isitifiketi sethu se-CE, ukugunyazwa kwe-ISO 13485 namazinga okukhiqiza e-GMP. Babike ukuthi bakhuphuke ngo-35% ekwanelisekeni kwesiguli kanye nokwehla ngo-28% kwezikhalo ezihlobene nomkhiqizo ezinyangeni ezingu-6. 'Ukungaguquguquki okuphezulu kwe-batch-to-batch kwezigcwalisi zethu kuholele emiphumeleni yokwelashwa engcono kakhulu kanye nokuzethemba kwesiguli,' kusho umqondisi wezokwelapha womtholampilo.
Namuhla, bangabasabalalisi bethu besifunda futhi sisebenzela ukwakha umugqa womkhiqizo ozimele wenethiwekhi yabo ekhulayo yemitholampilo.
Isiphetho Kungani Kufanele Ubeke Eqhulwini Isitifiketi Se-CE
Akuyona into ewubukhazikhazi, iwukudingeka ube nakho kubasabalalisi bokugcwalisa bamazwe ngamazwe, abanikazi bomkhiqizo nabasebenzi bemitholampilo abafuna ukungena emakethe yaseYurophu futhi bazuze ukwethenjwa kwamakhasimende afuna ngamandla. 'Imikhiqizo engaqinisekiswanga ngendlela efanele ikuchaya ezijezisweni zokulawula, ukulimaza isithunzi futhi okubaluleke nakakhulu, izingozi ekuphepheni kwesiguli.
Ukukhula okusimeme emakethe ekhanga kakhulu ye-aesthetics yezokwelapha emhlabeni kungafinyelelwa ngokusebenzisana nabakhiqizi abanezitifiketi ze-CE zokugcwalisa i-dermal, abanezindawo zokukhiqiza eziqinisekisiwe ze-ISO futhi abathobela imithetho. zokuhambisana nokulawula kokugcwalisa . izindinganiso
