Musika wepasi rose we hyaluronic acid based dermal fillers unokosha pamadhora mazana matanhatu nemazana manomwe emadhora muna 2025 uye unofungidzirwa kuti uchakura paCAGR ye12.4% kusvika madhora bhiriyoni gumi nepfumbamwe panosvika 2034. Uyu mukana unoshamisa we international filler distributor - kana iwe uchikwanisa kufamba nenzira yakaoma yekudzora mamiriro ekupinza uye kutengesa dermal fillers, kunyanya mumusika weEurope.
CE certification iri pamwoyo weiyi hutongi hwekutonga. Kunzwisisa iyo CE certification process yedermal fillers haingori mubvunzo wekuteedzera kune vanogovera, varidzi vekiriniki uye vanogadzira brand, mukana wekukwikwidza une chekuita nekugona kwako kuburitsa, kutengesa uye kutengesa zvigadzirwa izvi nechivimbo.
Chii chinonzi CE Certification uye Nei Chakakosha kune Dermal Fillers?
Mucherechedzo weEC unoshandiswa nevagadziri kuratidza kuti zvigadzirwa zvavo zvinozadzisa zvese zvakakosha zvinodiwa zvehutano hweEuropean hwakakodzera, chengetedzo uye mutemo wekuchengetedza kwezvakatipoteredza. Ichi chitupa chedermal fillers chiri pasi peMedical Devices Regulation (EU) 2017/745 (kureva MDR), iyo yakatanga kushanda zvizere muna Chivabvu 2021.
Pasi peMDR, dermal fillers inoiswa semidziyo yekurapa - kunyangwe ichishandiswa chete nekuda kwezvizoro senge wrinkle kugadzirisa kana kuwedzera miromo. Maererano neEU Medical Devices Regulation , ese madermal fillers akaiswa pamusika weEU anofanirwa kutakura mucherechedzo weEC kuratidza kuti vanozadzisa kuchengetedzeka uye kuita zvinodiwa.
Kune vanogovera uye varidzi vemhando, izvi zvinoreva chokwadi chakakomba: Kana zvigadzirwa zvako zvedermal filler zvisina kunyorwa CE, hazvigone kuiswa pamusika muEurope.
CE Certification Maitiro: Iyo Nhanho-ne-Nhanho Gwaro
Iyo CE certification process yedermal fillers inzira yakawanda-nhanho, inoda mari yakakura mumhando masisitimu, humbowo hwekiriniki uye hunyanzvi hwekutonga. Nzira yacho ndeiyi:
Danho 1: Rongedza chigadzirwa pasi peMDR
Dermal fillers akanyorwa muAnnex XVI yeMDR. Ichi chinongedzo chine chekuita nezvigadzirwa zvisina kuitirwa chinangwa chekurapa, asi izvo zvinoita semidziyo yekurapa uye zvinounza njodzi dzakafanana. Classification inoenderana nechigadzirwa:
● Absorbable dermal fillers anowanzoonekwa seKirasi III-njodzi huru.
● Zvigadzirwa zvine mishonga yemishonga (eg lidocaine) inoonekwa seyakasanganiswa zvigadzirwa zvinoenderana neChikamu 1(8) cheMDR.
Midziyo yeKirasi III inoda iyo yakaomesesa ongororo yekuongorora, kusanganisira inosungirwa zvidzidzo zvekiriniki zvakagadzirirwa uye zvakanangana zvakafanana nePhase III mishonga yemishonga.
Danho 2: Kudyidzana neMuviri Wakaziviswa
Vagadziri veClass III dermal fillers vanofanirwa kushanda neyakazvimiririra Notified Body, sangano rekuongorora zvinoenderana rakadomwa nevakuru veEuropean Union. Iyo Notified Body inoongorora zvinyorwa zvemugadziri zvehunyanzvi, mhando yekutonga system uye humbowo hwekiriniki isati yaburitsa CE certification.
Vagadziri vanofanirwa kugadzira data rekiriniki rakasimba rinoratidza kuchengeteka uye kushanda kwemafuta avo edermal.' Izvi zvinowanzobatanidza:
● Preclinical test (biocompatibility, sterilization kusimbiswa, zvidzidzo zvehupenyu hwesherufu)
● Zvidzidzo zvekiriniki muvanhu
● Zvidzidzo zvekutevera zvekurapa mushure mekutanga kwemusika (PMCF)
Nhanho 4: Certification yemhando yekutonga system
Vagadziri vanofanirwa kuita uye kuchengetedza yakasimbiswa yemhando manejimendi sisitimu, kazhinji ISO 13485 - inovhara matanho ese kubva padhizaini dhizaini kusvika pakugadzira uye mushure memusika kuongorora.
Kana mutumbi wakaziviswa uchinge wasimbisa kutevedza, mugadziri anodhirowa EU Declaration of Conformity uye anoisa mucherechedzo weEC pachigadzirwa. Chigadzirwa chacho chinozonyoreswa muEuropean Database paMedical Devices (EUDAMED) uye chakapihwa Unique Device Identification (UDI).
Izvi zvinorevei kune varidzi vemhando uye vanogovera
Kwauri iwe international filler distributor , zvisungo zvako zvekutonga zvinopfuura kungosarudza zvigadzirwa zvine CE certification. Pasi peMDR, Vatengesi vanofanira:
Tarisa CE yekumaka pane zvigadzirwa uye kuti akakodzera magwaro ehunyanzvi uye mirairo yekushandisa iripo
● Iva nechokwadi chokuti mazita acho anoenderana nemitauro yenyika yauri kuda
● Chengetedza marekodhi ekutsvakisisa uye ratidza kushingairira kune vane hunyanzvi
● Mamiriro ekuchengetedza uye ekufambisa haafaniri kukanganisa kutevedza kwechigadzirwa
Iwo mateki akakwira kune varidzi vemhando vanotarisa yakavanzika label kana OEM zvibvumirano. Iwe unofanirwa kuona kuti vaunoshanda navo vekugadzira vane CE certification uye mhando masisitimu uye zvigadziriso zvekugadzirisa kutsigira kuenderera mberi kwekuteerera.
Kutsvaga Yakavimbika CE Certification Partner
Haasi ese CE certification akafanana. Iyo yekare Medical Device Directive (MDD) ikozvino yatsiviwa neMedical Device Regulation (MDR) itsva iyo ine zvinodiwa zvakanyanya kuoma. Zvigadzirwa zvakasimbiswa pasi peiyo yekare sisitimu zvinofanirwa kuchinjika kuenda kuMDR certification pamberi paZvita 31, 2027 kana 2028 (zvichienderana nekuiswa kwenjodzi).
Hezvino zvimwe zvezvinhu zvikuru zvekutarisa paunenge uchiongorora vangangove vatengesi:
● Chitupa cheMDR CE chechokwadi (kwete chitupa cheMDD)
● ISO 13485 QMS certification
● GMP kugadzira (Kirasi 100 kana zviri nani)
● Uchapupu hwekiriniki hunotsigira kuchengetedzwa uye zvirevo zvekuita
● Mapepa emitemo akajeka anowanikwa kana achidiwa
AOMA: Yako CE-yakasimbiswa dermal filler kugovera shamwari
Kweanopfuura makore makumi maviri nematatu, AOMA CO., LTD. anga ari mubatsiri akavimbika kune vekunze vanogovera mafiller, makiriniki anoyevedza uye varidzi vemhando. Isu tinotumira zvigadzirwa zvedu kunyika dzinopfuura zana nemakumi maviri dzinosanganisira European Union, United States nemisika mikuru muLatin America, Middle East neAsia.
CE Certified Hunhu Iwe Unogona Kuvimba
Ese maAOMA dermal fillers anogadzirwa neruremekedzo ruzere kuEC uye FDA zvinodzora zviyero uye zvakasimbiswa kune ISO 13485 mhando manejimendi system. Tinodada kuva CE Certified dermal filler zvigadzirwa, kusangana nezvinoomesesa zvinodiwa zve EU Medical Devices Regulation - ichikupa iwe nevatengi vako chivimbo mujekiseni rega rega.
Takazvipira filler regulatory kutevedzera mukati mese maitiro ekugadzira, kubva payakasvibira yekuongorora kusvika kune aseptic kugadzira kusvika pakupedzisa chigadzirwa kuyedzwa.
Zvigadzirwa zvepasi rose zvekugadzira
Fekitori yedu inogara 4800 square metres, yakashongedzerwa neyekutanga-kirasi Kirasi 100 GMP mishonga yekugadzira mishonga musangano, iyo yepamusoro-soro muindasitiri. Nzvimbo iyi ine mitsetse mitatu yekugadzira ine simba rezuva nezuva re500,000 mayuniti e sodium hyaluronate gel. Inoshandisa michina yemhando yepamusoro, senge Germany's INOVA yakakwira-viscosity pre-yakazadzwa sirinji yekuzadza michina uye yeSweden GETINGE inogara-kudzvanya-kunyorova-kupisa sterilizer, kuve nechokwadi chekuenderana uye mhando mukugadzirwa kwakakura.
Indasitiri Recognitions
AOMA ndeimwe yevakuru gumi vagadziri ve hyaluronic acid fillers muChina uye yakabudirira kugadzirisa zvigadzirwa zvemhando dzinopfuura mazana mashanu nemakumi masere, ine mwero wekugutsikana kwevatengi we99.5%. Yedu ISO-yakasimbiswa Filler fekitori inoshanda kune matanhatu-sigma mhando zviyero. Isu tinopedza inodarika 10% yemari yedu yepagore paR&D.
OEM / ODM Kugona
Isu tiri nyanzvi HA vanotengesa kunze , vachipa ese-mu-imwe OEM / ODM masevhisi ane mavhiki maviri-3 chete yekugadzira yekutungamira nguva. Isu tine zvinopfuura chiuru zvakaratidzwa maumbirwo uye tinopa inochinjika gadziriso yekumaka, kurongedza, mafomula uye mavhoriyamu kuti akubatsire iwe kuvaka yako brand uchichengetedza hunhu uye kuteedzera.
Kunzwisisa Mitemo Yekupinza Mafirita
Chero mushambadzi anoda kukura mumusika weEurope anofanirwa kunzwisisa mirau yekuzadza kunze . Zvinodiwa zvikuru zvinosanganisira:
● Mucherechedzo weEC unofanirwa kuoneka zviri nyore pachigadzirwa uye kurongedza kwechigadzirwa.
● Mirayiridzo yekushandisa inofanira kunge iri mu(mi)tauro yepamutemo yenyika yauri kuda.
● Zvigadzirwa zvinoda UDI uye kunyoresa muEUDAMED.
● A post-market surveillance system ichagadzwa kuti itarise kushanda kwechigadzirwa uye kushuma zviitiko zvakashata.
AOMA inopa rutsigiro rwakasimba rwekutonga kune vatinogovera vatinoshanda navo kuburikidza nehunyanzvi zvinyorwa, zvitupa uye nhungamiro yekuteerera kuti ive nechokwadi chekuwana musika wakatsetseka.
Nyaya Yechidzidzo: Nyaya Yekubudirira Kwemutengi Chaiyo
Muna 2024, mushambadzi muEastern Europe - yepakati-saizi network yeaesthetic kiriniki - akatibata, achitsvaga akavimbika mutengesi weEC-yakasimbiswa dermal fillers. Pakutanga, vanga vachinetseka nekusaenderana kwemhando yechigadzirwa uye kushomeka kwemapepa emitemo kubva kumugadziri wavo wazvino, izvo zvaiisa bhizinesi ravo panjodzi.
Vakaisa odha yavo yekutanga yeHA fillers mushure mekuongorora yedu CE certification, ISO 13485 accreditation uye GMP mazinga ekugadzira. Vakashuma kuwedzera kwe35% mukugutsikana kwevarwere uye kuderera kwe28% muzvichemo zvine chokuita nechigadzirwa pamwedzi mitanhatu. 'Kuwanda kwebatch-to-batch kuenderana kwemafirita edu kwakonzera mhedzisiro yekurapa iri nani uye chivimbo chemurwere,' akadaro director wekiriniki.
Nhasi, ndivo vega vanogovera mudunhu uye tiri kushanda mukugadzira yakavanzika label chigadzirwa mutsara wetiweki yavo yekiriniki iri kukura.
Mhedziso Nei Uchifanira Kutungamira CE Certification
Haisi yeumbozha, ndiyo inofanirwa-kuve nayo kune vekunze vanogovera mafirita, varidzi vemhando uye vanoita zvekiriniki vanoda kupinda mumusika weEuropean uye kuhwina kuvimba kwevatengi vanoda. 'Zvigadzirwa zvisina kunyoreswa zvinofumura iwe kuzvirango zvekutonga, kukuvadza mukurumbira uye zvakanyanya kukosha, njodzi kukuchengetedzwa kwemurwere.
Kukura kwakasimba mumusika unoyevedza wekurapa aesthetics pasi rose kunogona kuwanikwa nekubatana nevagadziri vane CE Certified for dermal fillers, vane ISO certified yekugadzira zvivakwa uye vanotevedzera. filler regulatory compliance standards.
