Sɛnea CE Agyiraehyɛde Yɛ Adwuma Ma Dermal Fillers: Akwankyerɛ ma Amanaman Ntam Nkyekyɛmu Ne Brand Wuranom

Wiase nyinaa gua a ɛfa hyaluronic acid based dermal fillers ho no bo bɛyɛ dɔla ɔpepepem 6.7 wɔ afe 2025 mu na wɔhwɛ kwan sɛ ɛbɛkɔ soro wɔ CAGR a ɛyɛ 12.4% akɔduru bɛyɛ dɔla ɔpepepem 19.2 wɔ afe 2034. Eyi yɛ hokwan a ɛyɛ nwonwa ma obi amanaman ntam filler distributor – sɛ wubetumi akɔfa mmara a ɛyɛ den a ɛfa dermal fillers a wɔde ba amannɔne na wɔtɔn, titiriw wɔ Europa gua so a.

CE adansedi yɛ mmarahyɛ nniso yi mu ade titiriw. CE adansedie nhyehyɛeɛ a ɛfa dermal fillers ho nteaseɛ nyɛ asɛmmisa a ɛfa sɛdeɛ wɔdi mmara so ma wɔn a wɔkyekyɛ, ayaresabea wuranom ne wɔn a wɔyɛ ahyɛnsodeɛ no nko ara, ɛyɛ akansi mu mfasoɔ a ɛwɔ nkɛntɛnsoɔ tẽẽ wɔ wo tumi a wobɛtumi anya, de asie na woatɔn saa nneɛma yi wɔ ahotosoɔ mu.

Dɛn Ne CE Certification na Dɛn Nti na Ɛho Hia Ma Dermal Fillers?

Wɔn a wɔyɛ nneɛma no de CE agyiraehyɛde no di dwuma de kyerɛ sɛ wɔn nneɛma no di Europa akwahosan, ahobammɔ ne nneɛma a atwa yɛn ho ahyia ho banbɔ ho mmara a ɛfa ho no ahwehwɛde ahorow a ɛho hia nyinaa ho dwuma. Saa adansedie yi a ɛfa dermal fillers ho no wɔ Medical Devices Regulation (EU) 2017/745 (kyerɛ sɛ MDR) ase, a ɛbɛyɛɛ adwuma koraa wɔ May 2021 mu.

Wɔ MDR ase no, wɔkyekyɛ dermal fillers mu sɛ aduruyɛ mfiri – mpo bere a wɔde di dwuma de yɛ ahosiesie nkutoo te sɛ wrinkle correction anaa anofafa augmentation. Sɛnea EU kyerɛ no Medical Devices Regulation , ɛsɛ sɛ dermal fillers a wɔde gu EU gua so nyinaa kura CE agyiraehyɛde no de kyerɛ sɛ wodi ahobammɔ ne adwumayɛ ho ahwehwɛde ahorow a emu yɛ den so.

Wɔ wɔn a wɔkyekyɛ ne wɔn a wɔwɔ brand no fam no, eyi kyerɛ nokwasɛm a ɛho hia: Sɛ wo dermal filler nneɛma no nni CE agyiraehyɛde a, wontumi mfa nkɔ gua so wɔ Europa.

CE Adansedi Nhyehyɛe: Anamɔn biara Akwankyerɛ

CE adansedie nhyehyɛeɛ a wɔde ma dermal fillers no yɛ adeyɛ a ɛwɔ akwan ahodoɔ pii so, ɛhia sɛ wɔde sika kɛseɛ hyɛ nhyehyɛeɛ a ɛyɛ papa, ayaresabea adanseɛ ne mmara ho nimdeɛ mu. Adeyɛ no te sɛ nea edidi so yi:

Anamɔn 1: Fa aduru no to MDR ase

Wɔakyerɛw nnuru a wɔde hyɛ honam ani ma wɔ Annex XVI a ɛwɔ MDR no mu. Saa nkaeɛ yi fa nneɛma a wɔanhyɛ da sɛ ɛbɛnya aduruyɛ atirimpɔw, nanso ɛyɛ n’ade te sɛ aduruyɛ mfiri na ɛde asiane a ɛte saa ara ba. Nkyekyɛmu no gyina nneɛma a wɔyɛ no su so:

● Wɔtaa bu nnuru a wɔde hyɛ honam ani a wotumi twetwe no sɛ Class III—asiane a ɛsen biara.

● Wobu nnuru a nnuru wom (sɛ nhwɛso no, lidocaine) sɛ nnuru a wɔaka abom sɛnea MDR Ahyɛde 1(8) kyerɛ no.

Mfiri a ɛwɔ Class III no hwehwɛ sɛ wɔyɛ nhwehwɛmu a emu yɛ den sen biara a ɛfa sɛnea ɛne ne ho hyia ho, a ayaresabea nhwehwɛmu a ɛyɛ ahyɛde a wɔayɛ na ne kɛse te sɛ Ɔfã III nnuruyɛ sɔhwɛ ahorow ka ho.

Anamɔn 2: Wo ne Kuw a Wɔabɔ Wɔn Amanneɛbɔ Bɛbom ayɛ adwuma

Ɛsɛ sɛ wɔn a wɔyɛ Class III dermal fillers no ne Notified Body a ɛde ne ho, kuw bi a ɛhwɛ sɛnea ɛne ne ho hyia a Europa Aman Nkabom no mpanyimfo apaw no yɛ adwuma. Kuw a Wɔabɔ Wɔn Amanneɛ no hwɛ nea ɔyɛɛ no ​​no mfiridwuma ho nkrataa, nhyehyɛe a wɔde hwɛ nneɛma pa so ne ayaresabea adanse ansa na wɔde CE adansedi krataa ama.

Anamɔn 3: Adwumayɛ mu Nhwehwɛmu ne Ayaresabea Adanse

Ɛsɛ sɛ wɔn a wɔyɛ no yɛ ayaresabea ho nsɛm a ɛyɛ den a ɛkyerɛ ahobammɔ ne adwumayɛ a wɔn honam ani nneɛma a wɔde hyɛ wɔn honam ani ma no yɛ adwuma.' Eyi taa fa:

● Sɔhwɛ a wɔyɛ ansa na wɔayɛ aduruyɛ (biocompatibility, sterilization validation, shelf life studies) .

● Ayaresa mu nhwehwɛmu a wɔyɛe wɔ nnipa mu

● Nhwehwɛmu a wɔyɛe wɔ ayaresabea akyi a wɔde di gua akyi (PMCF) .

Anamɔn 4: Adansedie a ɛfa nhyehyɛeɛ a ɛfa nneɛma pa ho

Ɛsɛ sɛ wɔn a wɔyɛ nneɛma no de nhyehyɛe a wɔagye atom a wɔde hwɛ nneɛma pa so di dwuma na wɔhwɛ so—a mpɛn pii no ɛyɛ ISO 13485—a ɛfa nneɛma nyinaa ho fi nhyehyɛe a wɔhwɛ so kosi nneɛma a wɔyɛ ne nea wɔhwɛ so wɔ gua akyi so.

Anamɔn 5: CE Adansedi ne Mpaemuka a ɛkyerɛ sɛ ɛne ne ho hyia a wɔde ma

Sɛ adwumakuw a wɔabɔ wɔn amanneɛ no si so dua sɛ wɔadi mmara so wie a, nea ɔyɛe no kyerɛw EU Mpaemuka a Ɛfa Nea Ɛfa Ho no na ɔde CE agyiraehyɛde no hyɛ ade no so. Afei wɔkyerɛw ade no din wɔ European Database on Medical Devices (EUDAMED) mu na wɔma no Unique Device Identification (UDI).

Nea eyi kyerɛ ma brand wuranom ne wɔn a wɔkyekyɛ

Wo fam sɛ obi international filler distributor , wo mmara kwan so asɛyɛde ahorow kɔ akyiri sen sɛ wobɛpaw nneɛma a ɛwɔ CE adansedi krataa kɛkɛ. Wɔ MDR ase no, Wɔn a Wɔkyekyɛ nneɛma no bɛyɛ:

Hwɛ CE agyiraehyɛde a ɛwɔ nneɛma so ne sɛ mfiridwuma ho nkrataa a ɛfata ne akwankyerɛ a ɛfa sɛnea wɔde bedi dwuma ho wɔ hɔ anaa

● Hwɛ sɛ nkyerɛwde a wɔde kyerɛw so no ne ɔman a wɔde wɔn ani asi so no kasa a wɔhwehwɛ no hyia

● Yɛ kyerɛwtohɔ a ɛkyerɛ sɛnea wobetumi ahwehwɛ nneɛma mu na kyerɛ mmɔdenbɔ a ɛfata kyerɛ atumfoɔ a wɔfata

● Tebea a wɔde sie ne nea wɔde fa so no rennya sɛnea nneɛma no di so no so nkɛntɛnso

Stakes no yɛ kɛse ma brand wuranom a wɔn ani da private label anaa OEM deals. Ɛsɛ sɛ wohwɛ sɛ wo mfɛfoɔ a wɔyɛ nneɛma no wɔ CE adansedie ne nhyehyɛeɛ a ɛyɛ papa ne mmara nhyehyɛeɛ a ɛbɛboa ma wɔakɔ so adi mmara so.

CE Adansedi Ho Ɔhokafo a Wogye Di a Wobɛhwehwɛ

Ɛnyɛ CE adansedi nkrataa nyinaa na ɛyɛ pɛ. Mprempren wɔde Medical Device Directive (MDD) dedaw no asi Medical Device Regulation (MDR) foforo a ɛwɔ ahwehwɛde ahorow a emu yɛ den koraa no ananmu. Ɛsɛ sɛ nneɛma a wɔagye atom wɔ nhyehyɛeɛ dedaw no ase no dan kɔ MDR adansedie no so ansa na December 31, 2027 anaa 2028 adu (ɛgyina asiane nkyekyɛmu so).

Nneɛma atitiriw a ɛsɛ sɛ wohwehwɛ bere a woresusuw wɔn a wobetumi de nneɛma ama ho no bi ni:

● MDR CE adansedi krataa a ɛfata (ɛnyɛ MDD adansedi krataa) .

● ISO 13485 QMS adansedi krataa

● GMP a wɔyɛ (Klas 100 anaa nea ɛboro saa) .

● Adanse a ɛwɔ ayaresabea a ɛfoa ahobammɔ ne adwumayɛ ho nsɛm a wɔka so

● Mmara ho nkrataa a emu da hɔ a wobetumi anya bere a wɔhwehwɛ

AOMA: Wo hokafo a ɔkyekyɛ dermal filler a ɔwɔ CE adansedi krataa

Bɛboro mfe 23 ni no, AOMA CO., LTD. ayɛ ɔhokafo a wogye no di ma amanaman ntam filler kyekyɛfo, afɛfɛde ayaresabea ahorow ne brand wuranom. Yɛde yɛn nneɛma kɔ aman bɛboro 120 a Europa Aman Nkabom, United States ne gua akɛse a ɛwɔ Latin Amerika, Mfinimfini Apuei ne Asia ka ho.

CE Certified Quality a Wubetumi de Wo Ho Ato Hɔ

Wɔde obuo a edi mũ ma CE ne FDA mmara gyinapɛn ahorow na ɛyɛ AOMA dermal fillers nyinaa na wɔagye atom sɛ ISO 13485 quality management system. Ɛyɛ yɛn ahomaso sɛ yɛyɛ saa CE adansedi krataa dermal filler products, a edi ahwehwɛde a emu yɛ den a ɛwɔ... EU Medical Devices Regulation – ɛma wo ne w’afɛfoɔ ahotosoɔ wɔ injection biara mu.

Yɛasi yɛn bo sɛ filler mmara a wodi so wɔ nneɛma a wɔyɛ no nyinaa mu, efi nneɛma a wɔde yɛ nhwehwɛmu so kosi aseptic a wɔyɛ so kosi nneɛma a wɔawie ho sɔhwɛ so.

Wiase nyinaa adwumayɛbea ahorow a wɔyɛ nneɛma

Yɛn adwumayɛbea no wɔ beae a ɛyɛ mita 4800 ahinanan, a wɔde Class 100 GMP nnuruyɛ adwumayɛbea a edi kan, gyinapɛn a ɛkorɔn sen biara wɔ adwuma no mu ahyɛ mu. Adwumayɛbea no wɔ mmeae abiɛsa a wɔyɛ nneɛma a wɔde sodium hyaluronate gel a ɛyɛ 500,000 da biara da. Ɛde nnwinnade a ɛkɔ anim te sɛ Germany mfiri a wɔde hyɛ syringe a wɔde ahyɛ mu ma a ɛyɛ den kɛse a wɔfrɛ no INOVA ne Sweden mfiri a wɔde hyɛ syringe mu a ɛyɛ den kɛse ne Sweden GETINGE a ɛma ɔhyew a ɛyɛ nwini a ɛyɛ hyew bere nyinaa a wɔde kum ɔyare mmoawa di dwuma de hwɛ hu sɛ ɛyɛ nea ɛkɔ so pɛpɛɛpɛ na ɛyɛ papa wɔ nneɛma akɛse a wɔyɛ mu.

Nnwumayɛbea a Wogye Tom

AOMA yɛ 10 a wɔyɛ hyaluronic acid fillers a ɛwɔ China no mu biako na wayɛ nneɛma a wɔayɛ no yiye ama bɛboro 580 brands, a adetɔfo akomatɔyam dodow yɛ 99.5%. Yɛn ISO-certified Filler adwumayɛbea no yɛ adwuma wɔ six-sigma quality gyinapɛn ahorow. Yɛsɛe yɛn afe afe sika a yɛnya no bɛboro 10% wɔ R&D ho.

OEM / ODM Tumi

Yɛyɛ adwumayɛfo a wɔyɛ adwumaden HA fillers exporters , de ne nyinaa-wɔ-baako OEM / ODM nnwuma a adapɛn 2-3 pɛ production lead time ma. Yɛwɔ bɛboro 1,000 a wɔada no adi sɛ yɛyɛ na yɛde nsakraeɛ a ɛyɛ mmerɛw a ɛfa ahyɛnsodeɛ, nneɛma a wɔde kyekyere, nnuru ne dodoɔ ho ma de boa wo ma wokyekye w’ankasa ahyɛnsodeɛ berɛ a wokura su ne mmara sodi mu.

Mmara a Ɛfa Fillers a Wɔde Ba amannɔne Ho no ntease

Ɛsɛ sɛ obiara a ɔkyekyɛ nneɛma a ɔpɛ sɛ onyin kɔ Europa gua so no te filler import ho mmara ase . Ahwehwɛde atitiriw bi ne:

● Ɛsɛ sɛ ɛyɛ mmerɛw sɛ wobehu CE agyiraehyɛde no wɔ ade no ne nneɛma a wɔde ahyɛ mu no so.

● Ɛsɛ sɛ akwankyerɛ a wɔde bedi dwuma no yɛ ɔman a wɔde wɔn ani asi so no kasa (kasa) a wɔde di dwuma no mu.

● Nneɛma a wɔyɛ no hia UDI ne wɔn din a wɔbɛkyerɛw wɔ EUDAMED mu.

● Wɔbɛhyehyɛ nhyehyɛe bi a wɔde bɛhwɛ nneɛma so wɔ gua akyi de ahwɛ sɛnea nneɛma no yɛ adwuma na wɔabɔ nneɛma bɔne ho amanneɛ.

AOMA de mmara kwan so mmoa a emu yɛ den ma yɛn ahokafoɔ a wɔkyekyɛ nneɛma denam mfiridwuma ho nkrataa, adansedie ne akwankyerɛ a ɛfa mmara a wɔdi soɔ no so de hwɛ sɛ gua so kɔ so yie.

Nsɛm a Wɔayɛ no Ho Nhwehwɛmu: Adetɔfo Nkonimdi Ho Asɛm Ankasa

Wɔ afe 2024 mu no, obi a ɔkyekyɛ nneɛma wɔ Europa Apuei fam – afɛfɛde ayaresabea ahorow a ɛwɔ mfinimfini – ne yɛn dii nkitaho, hwehwɛɛ obi a wotumi de ho to no so a ɔde nnuru a wɔde hyɛ honam ani aduru a wɔagye atom sɛ CE bɛma. Kan no, na wɔapere wɔ nneɛma a wɔyɛ no yiye a ɛnhyia ne mmara ho nkrataa a wonnya mfi wɔn mprempren yɛfo no hɔ, na ɛde wɔn adwuma no too asiane mu.

Wɔde wɔn ahyɛde a edi kan ma HA fillers bere a wɔhwɛɛ yɛn CE adansedi, ISO 13485 accreditation ne GMP adwumayɛ gyinapɛn ahorow akyi. Wɔbɔɔ amanneɛ sɛ ayarefoɔ abotɔyam kɔɔ soro 35% na anwiinwii a ɛfa nneɛma a wɔyɛ ho no so tew 28% wɔ asram 6 mu. 'Yɛn fillers no batch-to-batch consistency a ɛkorɔn no ama ayaresa no aba yiye kɛse ne ayarefo ahotoso,' ayaresabea no aduruyɛ kwankyerɛfo no kae.

Ɛnnɛ, wɔn nko ara ne yɛn kyekyɛfoɔ ma ɔmantam no na yɛreyɛ adwuma de ayɛ private label product line ama wɔn ayaresabea ahodoɔ a ɛrenya nkɔsoɔ.

Awiei Nea Enti a Ɛsɛ sɛ Wode CE Adansedi Di Kan

Ɛnyɛ afɛfɛde, ɛyɛ ade a ɛsɛ sɛ amanaman ntam filler kyekyɛfo, brand wuranom ne ayaresabea adwumayɛfo a wɔpɛ sɛ wɔhyɛn Europa gua so na wonya ahotoso a adetɔfo a wɔhwehwɛ nneɛma pii no nya. 'Nneɛma a wɔagye ho adanseɛ a ɛntene no ma woto mmara mu asotweɛ, din a wɔsɛe no ne nea ɛho hia sen saa no, asiane a ɛwɔ ayarefoɔ ahobanbɔ mu.'

Wobetumi anya nkɔso a ɛtra hɔ daa wɔ aduruyɛ mu afɛfɛde gua a ɛyɛ anigye sen biara wɔ wiase no mu denam adwumayɛkuw a wɔne adwumayɛfo a wɔwɔ CE adansedi krataa ma dermal fillers, wɔwɔ ISO adansedi krataa a wɔde yɛ nneɛma na wodi mmara so no so filler mmara a wodi so gyinapɛn ahorow.