Xexeame katã ƒe asi na hyaluronic acid based dermal fillers ƒe asixɔxɔ anɔ abe $6.7 biliɔn le ƒe 2025 me eye wobu akɔnta be adzi ɖe edzi le CAGR si nye 12.4% be wòaɖo $19.2 biliɔn kloe le ƒe 2034. Esia nye mɔnukpɔkpɔ wɔnuku aɖe na ame aɖe dukɔwo dome filler mama – ne ète ŋu zɔ mɔ le se sesẽ ƒe nɔnɔme si me wotsɔa dermal fillers tsɔtsɔ tso duta kple edzadzra, vevietɔ le Europa ƒe asi me.
CE ƒe ɖaseɖigbalẽe nye ɖoɖo sia ƒe taɖodzinu. CE ƒe ɖaseɖigbalẽ nana ƒe ɖoɖo si wowɔna na ŋutigbalẽ me nuzazãwo gɔmesese menye sedziwɔwɔ ƒe nya na mamalawo, atikewɔƒewo tɔ kple adzɔnu ƒe ŋkɔ wɔlawo ko o, ke boŋ enye hoʋiʋli ƒe viɖe si kpɔa ŋusẽ ɖe wò ŋutete dzi tẽ be nàkpɔ atike siawo tso teƒe, adzra wo ɖo ahadzra wo kple kakaɖedzi.
Nukae Nye CE Ðaseɖigbalẽ Eye Nukatae Wòle Vevie Na Dermal Fillers?
CE dzesia nye esi adzɔnuwo wɔlawo zãna tsɔ ɖenɛ fiana be yewoƒe adzɔnuwo ɖo Europa ƒe lãmesẽ, dedienɔnɔ kple nutome takpɔkpɔ ƒe se siwo ku ɖe eŋu ƒe nudidi veviwo katã gbɔ. Ðaseɖigbalẽ sia na ŋutigbalẽtikewo le Atikewɔnuwo Ŋuti Sedede (EU) 2017/745 (si nye MDR) te, si va dze dɔwɔwɔ gɔme bliboe le May 2021 me.
Le MDR te la, woda dermal fillers ɖe hatsotso me be wonye atikewɔnuwo – ne wozãe na atsyɔ̃ɖoɖo ƒe taɖodzinuwo abe flitete ɖɔɖɔɖo alo nuyi dzi ɖeɖeko ene gɔ̃ hã. Le EU ƒe nya nu la Medical Devices Regulation , ele be ŋutigbalẽtike siwo katã woda ɖe EU ƒe asi me la natsɔ CE ƒe dzesi atsɔ aɖee afia be yewowɔ ɖe dedienɔnɔ kple dɔwɔwɔ ƒe nudidi sesẽwo dzi.
Le emamalawo kple adzɔnuawo tɔ gome la, esia fia nu ŋutɔŋutɔ vevi aɖe: Ne womede dzesi wò atike siwo wotsɔ yɔa ŋutigbalẽe o la, womate ŋu atsɔ wo ade asi me le Europa o.
CE ƒe Ðaseɖigbalẽ nana ƒe Dɔwɔna: Afɔɖeɖe ɖesiaɖe ƒe Mɔfiame
CE ƒe ɖaseɖigbalẽ nana ƒe ɖoɖo si wowɔna na ŋutigbalẽ me nusiwo wotsɔ yɔa ŋutigbalẽ me nye dɔwɔwɔ si me wowɔa nu geɖe le, si bia be woade ga geɖe ɖe nyonyome ƒe ɖoɖowo, dɔdaƒe ƒe kpeɖodziwo kple ɖoɖowɔwɔ ŋuti nunya me. Alesi wowɔa dɔae nye esi:
Afɔɖeɖe 1: Da atike la ɖe hatsotsowo me le MDR te
Woŋlɔ atike siwo wotsɔna yɔa ŋutigbalẽ me ɖe MDR ƒe Annex XVI me. Megbenya sia ku ɖe atike siwo womeɖo be woawɔ atike na wo o, gake wowɔa nu abe atikewɔnuwo ene eye wohea afɔku mawo tɔgbe vɛ. Woda wo ɖe hatsotsowo me le nusiwo wowɔ ƒe nɔnɔmewo nu:
● Zi geɖe la, wobua ŋutigbalẽ me nusiwo woate ŋu axɔ ɖe lãme na ame be wonye hatsotso III—si nye afɔku gãtɔ kekeake.
● Wobua atike siwo me atikewo le (le kpɔɖeŋu me, lidocaine) be wonye atike siwo wotsɔ ƒo ƒui le MDR ƒe Nyati 1(8) nu.
Mɔ̃ siwo le hatsotso III me hiã be woawɔ dodokpɔ sesẽtɔ kekeake le alesi wowɔa dɔe ŋu, si me dɔdamɔnu ŋuti numekuku siwo wòle be woawɔ siwo ŋu wotrɔ asi le eye woƒe lolome sɔ kple Akpa III ƒe atike dodokpɔwo hã le.
Afɔɖeɖe 2: Nuwɔwɔ aduadu kple Habɔbɔ si Wona Nyatakaka
Ele be atike siwo wotsɔna yɔa ŋutigbalẽ ƒe hatsotso III wɔlawo nawɔ dɔ kple Dɔwɔƒe si Wona Nyatakaka si le eɖokui si, si nye habɔbɔ si léa ŋku ɖe nusiwo sɔ ŋu si Europa Dukɔwo ƒe Ðekawɔha ƒe dziɖuɖumegãwo tia. Habɔbɔ si Wonya la léa ŋku ɖe adzɔnuwɔƒea ƒe mɔ̃ɖaŋu ŋuti nuŋlɔɖiwo, nyonyome dzikpɔkpɔ ƒe ɖoɖo kple dɔdaƒe ƒe kpeɖodziwo ŋu hafi naa CE ɖaseɖigbalẽ.
Ele be adzɔnuwo wɔlawo nawɔ dɔdamɔnu ŋuti nyatakaka sesẽ siwo ɖo kpe woƒe ŋutigbalẽ me atikewo ƒe dedienɔnɔ kple dɔwɔwɔ dzi.' Zi geɖe la, esia lɔ:
● Dodokpɔ si wowɔ do ŋgɔ na dɔdamɔnu (nu gbagbewo ƒe dɔwɔwɔ ƒe ɖekawɔwɔ, vidzidzi ƒe kpeɖodzi, vidzidzi ƒe agbenɔƒe ŋuti numekukuwo) .
● Dɔdamɔnu ŋuti numekuku siwo wowɔ le amegbetɔwo ŋu
● Numekuku siwo wowɔna tsɔ kplɔa ame ɖo le asi me dodo vɔ megbe (PMCF) .
Afɔɖeɖe 4: Ðaseɖigbalẽ nana le nyonyome dzikpɔkpɔ ƒe ɖoɖoa ŋu
Ele be adzɔnuwo wɔlawo nawɔ ɖoɖo si ŋu woɖo kpee be woatsɔ akpɔ nyonyome dzi—zi geɖe la, ISO 13485—si axɔ afɔɖeɖewo katã tso aɖaŋuwɔwɔ dzi kpɔkpɔ dzi va ɖo ewɔwɔ kple ŋkuléle ɖe wo ŋu le asitsatsa megbe dzi ahalé eme ɖe asi.
Afɔɖeɖe 5: CE Ðaseɖigbalẽ kple Gbeƒãɖeɖe si ɖee fia be wowɔ ɖeka kple wo nɔewo
Ne dɔwɔƒe si wona nyanyae ɖo kpe edzi be wowɔ ɖe seawo dzi ko la, adzɔnuwɔƒea ŋlɔa EU ƒe Nyatakaka si ku ɖe Nusiwo Wowɔ Ðe Ðoɖo Nu ŋu eye wòdea dzesi CE ɖe adzɔnua ŋu. Emegbe woŋlɔa atike la ŋkɔ ɖe Europa ƒe Atikewɔnuwo Ŋuti Nyatakakadzraɖoƒe (EUDAMED) eye wodea Mɔ̃ɖaŋununya ƒe Dzesidegbalẽvi Tɔxɛ (UDI) asi na wo.
Nusi esia fia na adzɔnu ƒe ŋkɔ tɔ kple emamalawo
Na wò abe ame aɖe ene international filler distributor , wò sedziwɔwɔ ƒe agbanɔamedziwo yi ŋgɔ wu nusiwo ŋu CE ƒe ɖaseɖigbalẽ le tiatia ko. Le MDR te la, Mamãlawo awɔ:
Kpɔ dzesi si nye CE le adzɔnuwo ŋu eye be mɔ̃ɖaŋununya ŋuti nuŋlɔɖi siwo sɔ kple wo zazã ŋuti mɔfiamewo li hã
● Kpɔ egbɔ be dzesideŋkɔa wɔ ɖeka kple gbegbɔgblɔ ƒe nudidi siwo le dukɔ si ŋu nèle nu ƒom tsoe la me
● Wɔ nuŋlɔɖi siwo ku ɖe alesi woate ŋu ake ɖe wo ŋui ŋu eye nàɖe veviedodonu si sɔ afia dziɖuɖumegã siwo dze
Nusiwo le eme la lolo wu na adzɔnu ƒe ŋkɔ tɔ siwo le ŋku lém ɖe ame ŋutɔ ƒe ŋkɔ alo OEM ƒe nubablawo ŋu. Ele be nàɖo kpe edzi be CE ƒe ɖaseɖigbalẽ kple nyonyome ƒe ɖoɖowo kple ɖoɖowɔɖiwo le wò adzɔnuwo wɔwɔ ƒe hadɔwɔlawo si be woado alɔ sedziwɔwɔ si yia edzi.
CE ƒe Ðaseɖigbalẽ ƒe Dɔwɔhati si Dzi Woka Ðo Didi
Menye CE ƒe ɖaseɖigbalẽwo katãe sɔ o. Fifia wotsɔ Atikewɔnuwo Ŋuti Mɔfiame (MDD) xoxoa ɖɔ li Atikewɔnuwo Ŋuti Se yeye (MDR) si me nudidi sesẽwo le wu sã. Ele be adzɔnu siwo ŋu woɖo kpee le ɖoɖo xoxoa te la natrɔ ayi MDR ƒe ɖaseɖigbalẽa gbɔ do ŋgɔ na December 31, 2027 alo 2028 (le afɔku ƒe hatsotsowo nu).
Nu vevi siwo wòle be nàdi ne èle amesiwo ate ŋu ana nuawo me dzrom la dometɔ aɖewoe nye esi:
● MDR CE ɖaseɖigbalẽ si sɔ (menye MDD ɖaseɖigbalẽ o) .
AOMA: Wò dɔwɔhati si xɔ ŋutigbalẽ me tsiwo mama si xɔ ɖaseɖigbalẽ le CE
Ƒe 23 kple edzivɔe nye sia si AOMA CO., LTD. nye hadɔwɔla si dzi woka ɖo na dukɔwo dome filler mamalawo, atsyɔ̃ɖoɖodɔwɔƒewo kple adzɔnu ƒe ŋkɔ tɔ. Míeɖoa míaƒe adzɔnuwo ɖe dukɔ siwo wu 120 siwo dometɔ aɖewoe nye Europa Dukɔwo ƒe Habɔbɔ, United States kple asi gãwo le Latin Amerika, Titina Ɣedzeƒe kple Asia.
CE Ðaseɖigbalẽ Dzedzeme Si Dzi Nàte Ŋu Aka Ðe
Wowɔa AOMA ƒe ŋutigbalẽtikewo katã kple bubu blibo le CE kple FDA ƒe sedziwɔwɔ ƒe dzidzenuwo ŋu eye woɖo kpe edzi be woda asi ɖe ISO 13485 ƒe nyonyome dzikpɔkpɔ ƒe ɖoɖo dzi. Enye dada na mí be míele nenema CE ƒe ɖaseɖigbalẽ dermal filler products, si ɖoa nudidi sesẽ siwo le... EU ƒe Atikewɔnuwo ƒe Sedede – si naa kakaɖedzi wò kple wò asisiwo le atike ɖesiaɖe dodo me.
Míeɖoe kplikpaa be filler ƒe sewo dzi wɔwɔ le ewɔwɔ ƒe ɖoɖo bliboa me, tso nusiwo wotsɔ wɔe ƒe dodokpɔ dzi va ɖo aseptic wɔwɔ dzi va ɖo nusiwo wowɔ vɔ dodokpɔ dzi.
Adzɔnuwɔƒe siwo de ŋgɔ wu le xexeame katã
Míaƒe dɔwɔƒea xɔ teƒe si ƒe lolome nye meta 4800 sq, eye wotsɔ atikewɔƒe si nye klass 100 GMP ƒe atikewɔƒe si nye ɖoƒe kɔkɔtɔ kekeake, si nye dzidzenu kɔkɔtɔ kekeake le dɔwɔƒea, ɖo eŋu. Dɔwɔƒe etɔ̃ le dɔwɔƒea si woate ŋu awɔ sodium hyaluronate gel unit 500,000 gbesiagbe. Ezãa dɔwɔnu deŋgɔwo, abe Germany ƒe INOVA ƒe mɔ̃ siwo wotsɔ yɔa atikekui siwo me wodea tsii do ŋgɔ siwo me wodea tsii ŋutɔ kple Sweden ƒe GETINGE ƒe dɔlékuiwutike siwo me dzoxɔxɔ le si me dzoxɔxɔ le ɣesiaɣi, tsɔ kpɔa egbɔ be wowɔa nu ɖekae eye woƒe nyonyome le ewɔwɔ gãwo me.
Dɔwɔƒewo ƒe Dzesidede
AOMA nye hyaluronic acid fillers wɔla 10 gãtɔwo dometɔ ɖeka le China eye wòtrɔ asi le adzɔnuwo ŋu dzidzedzetɔe na adzɔnu siwo wu 580, eye asisiwo ƒe dzidzemekpɔkpɔ ƒe agbɔsɔsɔme nye 99.5%. Míaƒe ISO-ɖaseɖigbalẽ Filler dɔwɔƒe wɔa dɔ le ade-sigma nyonyome dzidzenuwo. Míezãa míaƒe ƒe sia ƒe ƒe asitsatsa ƒe 10% kple edzivɔ ɖe Numekuku kple Dɔwɔnawo ŋu.
OEM / ODM Ŋutete
Míenye dɔnyala bibiwo HA fillers exporters , nana katã-le-ɖeka OEM / ODM subɔsubɔdɔwo kple kwasiɖa 2-3 ko wɔwɔ kplɔ ɣeyiɣi. Míekpɔ atikewɔmɔnu siwo ŋu kpeɖodzi le wu 1,000 eye míenaa adzɔnu ƒe dzeside, nubablɛ, atikewɔmɔnu kple agbɔsɔsɔme ƒe tɔtrɔ si te ŋu trɔna bɔbɔe be wòakpe ɖe ŋuwò nàtu wò ŋutɔ wò adzɔnu ƒe dzesi esime nèléa nyonyome kple sewo dzi wɔwɔ me ɖe asi.
Se Siwo Ku Ðe Fillers Siwo Wotsɔ Va Duta Ŋu Gɔmesese
Ele be mamala ɖesiaɖe si di be yeatsi ayi Europa ƒe asi me nase filler import ƒe sewo gɔme . Nudidi veviwo dometɔ aɖewoe nye:
● Ele be CE ƒe dzesi nadze le atike la kple nusi wotsɔ blae dzi bɔbɔe.
● Ele be mɔfiame siwo ku ɖe eŋudɔwɔwɔ ŋu nanɔ dukɔ si me wole nu ƒom tsoe ƒe gbegbɔgblɔ(wo) me.
● Adzɔnuwo hiã UDI kple ŋkɔ ŋɔŋlɔ ɖe EUDAMED me.
● Woaɖo ŋkuléle ɖe nuawo ŋu le asitsatsa megbe ƒe ɖoɖo aɖe be wòalé ŋku ɖe adzɔnuwo ƒe dɔwɔwɔ ŋu ahagblɔ nu gbegblẽ siwo do mo ɖa.
AOMA naa ɖoɖowɔwɔ ƒe kpekpeɖeŋu sesẽ míaƒe mama hadɔwɔlawo to mɔ̃ɖaŋu ŋuti nuŋlɔɖiwo, ɖaseɖigbalẽwo kple sedziwɔwɔ ŋuti mɔfiamewo dzi be woakpɔ egbɔ be asitsatsa le edzi yim nyuie.
Le ƒe 2024 me la, numamãla aɖe le Ɣedzeƒe Europa – atsyɔ̃ɖoɖodɔwɔƒewo ƒe habɔbɔ si lolo titina – do ka kpli mí, henɔ ŋutigbalẽ me atike siwo ŋu CE ɖo kpee ƒe dɔwɔƒe si ŋu kakaɖedzi le dim. Do ŋgɔ la, wowɔa avu kple adzɔnuwo ƒe nyonyome si mewɔ ɖeka o kple sedziwɔwɔ ŋuti agbalẽ siwo tso woƒe adzɔnuwɔƒe si li fifia gbɔ ƒe anyimanɔmanɔ, si na woƒe dɔwɔƒea de afɔku me.
Wowɔ woƒe nudɔdɔ gbãtɔ na HA fillers le míaƒe CE ɖaseɖigbalẽ, ISO 13485 ƒe ɖaseɖigbalẽ kple GMP wɔwɔ ƒe dzidzenuwo me toto vɔ megbe. Wogblɔ be dɔnɔwo ƒe dzidzemekpɔkpɔ dzi ɖe edzi 35% eye nyatoƒoetoto siwo ku ɖe atikewo ŋu dzi ɖe kpɔtɔ 28% le ɣleti 6 me. 'Míaƒe fillers ƒe batch-to-batch ƒe ɖekawɔwɔ gã la na be atikewɔwɔ me tsonu nyo ɖe edzi ŋutɔ eye dɔnɔwo ka ɖe edzi,' atikewɔƒea ƒe atikewɔlawo ƒe amegã gblɔ.
Egbea la, woawo koe nye míaƒe mamala ɖeka kolia na nutoa eye míele dɔ wɔm be míawɔ adzɔnuwo ƒe hatsotso si ŋu ame ŋutɔ ƒe ŋkɔ le na woƒe atikewɔƒe siwo le dzidzim ɖe edzi.
Nyataƒoƒo Nusita Wòle Be Nàtsɔ CE ƒe Ðaseɖigbalẽ Naxɔ Nu Gbãtɔ
Menye atsyɔ̃ɖoɖoe wònye o, ke boŋ enye nusi wòle be dukɔwo dome filler mamalawo, adzɔnu ƒe ŋkɔwo tɔ kple atikewɔƒedzikpɔla siwo di be yewoage ɖe Europa ƒe asi me eye yewoaxɔ asisi siwo dia nu geɖe la ƒe kakaɖedzi. 'Adzɔnu siwo ŋu woɖo kpee nyuie o la doa go wò ɖe sedede ƒe tohehewo, ŋkɔ gbegblẽ kple vevietɔ wu la, afɔku siwo le dɔnɔwo ƒe dedienɔnɔ ŋu.'
Woate ŋu akpɔ dzidziɖedzi si anɔ anyi ɖaa le atikewɔwɔ ƒe atsyɔ̃ɖoɖo ƒe asi si hea ame wu le xexeame me ne wowɔ ɖeka kple adzɔnuwɔƒe siwo xɔ CE ƒe ɖaseɖigbalẽ na ŋutigbalẽ me nusiwo wotsɔ yɔa ŋutigbalẽ me, siwo si ISO ƒe ɖaseɖigbalẽ le le wɔwɔƒewo eye wowɔ ɖe se dzi filler ƒe ɖoɖowo dzi wɔwɔ ƒe dzidzenuwo.
