Ukubaluleka kokuMakishwa kweCE kwiiMveliso zeMesotherapy kwiMarike yaseYurophu

Intshayelelo: IMarike ye-Mesotherapy yaseYurophu: Amathuba kunye nokuThotyelwa kweMigangatho Ahlangene

Imakethi yonyango yobuhle obungeyonto yotyando eYurophu ikhula ngesantya sonyaka se-9.2%, phakathi kwayo i-Mesotherapy yenye yezona ndawo zikhula ngokukhawuleza. Nangona kunjalo, amathuba emarike ahamba kunye nemiqobo engqongqo yolawulo. Ngaphezu kwe-70% yababoneleli abangengabo abe-EU abakwazi ukungena ngenxa yokungaphumeleli kwabo ukuhlangabezana neemfuno ezinzima zokuthotyelwa. Njengeklinikhi, umthengisi okanye umphathi wokuthenga, kufuneka uqonde ngokuchanekileyo kwaye uphendule kwezi mfuno, ukuguqula ukuthotyelwa kwexabiso lexabiso ukuya kukhuphiswano olungundoqo.

Eli nqaku lijolise ekunikeni isikhokelo esicacileyo malunga nendlela yokwakha intembeko yeemarike kunye nokuqinisekisa impumelelo yoshishino ngokuhlangabezana neemfuno zolawulo lwaseYurophu. Undoqo ulele ekuqondeni ukuba uphawu lwe-CE kwiimveliso ze-Mesotherapy ayisiyo ileyibhile esemthethweni kuphela, kodwa kunye nobungqina bokhuseleko, ukusebenza kunye nomgangatho weemveliso.

Isiseko soMthetho kunye neNdlela yokuFumana yokuMakisha i-CE

Ukuhlelwa kweMveliso yindawo yokuQala yokuThotyelwa

Isinyathelo sokuqala kukuchaza ngokuchanekileyo isazisi esisemthethweni semveliso, emisela indlela yokulawula esebenzayo. KwiManyano yaseYurophu, Iimveliso ze-Mesotherapy zihlelwa ngokubanzi njengezixhobo zonyango okanye izithambiso ezisekelwe kusetyenziso olucetyiweyo. Ukuba imveliso ithi ineenjongo zonyango ezifana nokuxilonga, ukunyanga okanye ukunciphisa iimeko zolusu, iya kuhlelwa njengesixhobo sonyango kwaye ixhomekeke kwiMimiselo yeSixhobo sezoNyango. Ukuba isetyenziselwa kuphela iinjongo ezisisiseko ezifana nokucoca okanye ukuhombisa, kufuneka ilawulwe njengento yokuthambisa. Iimpazamo zokuhlela ziya kukhokelela ngokuthe ngqo ekungaphumeleliyo ukufikelela kwimarike kunye nobungozi obunokubakho bomthetho.

Isiqinisekiso phantsi kweNkqubo-sikhokelo ye-Mdr Senze iiNguquko eziSisiseko

Ukususela ekuphunyezweni kwe-EU's Medical Device Regulation, inkqubo kunye neemfuno zokufumana isatifikethi sokumakisha i-CE ziye zaqiniswa kakhulu. Le nkqubo itshintshile ekubeni izazise kakhulu ngabavelisi ukuya kuvavanyo olubanzi olubandakanya iqumrhu elazisiweyo elichongwe yiManyano yaseYurophu. Okwangoku, indlela yokuthotyelwa kufuneka ibandakanye amaxwebhu obugcisa, uvavanyo lweklinikhi, ukuphicothwa kwenkqubo yokulawula umgangatho, kunye nokusekwa kwenkqubo yokulawula emva kokuthengisa. Inkqubo epheleleyo yoqinisekiso idla ngokuthatha iinyanga ezili-12 ukuya kwezingama-24 kwaye ivelise amakhulukhulu amaphepha wamaxwebhu obugcisa. Kubathengisi abaceba ukuthumela ngaphandle, ukuqonda imimiselo yokuthumela ngaphandle elizweni jikelele yeenaliti ze-cosmetic linyathelo lokuqala elikhokelela kwisicwangciso esiyimpumelelo.

Inkqubo yoMgangatho: Ilitye lembombo loKhuseleko kunye nokuThobela

I-ISO 13485 kunye ne-Gmp Ndawonye zenza iNkqubo yoQinisekiso loMgangatho

Ukhuseleko lwemveliso lusekelwe kwinkqubo yomgangatho wemveliso. Kwi -ISO 13485 yezitofu zobuhle , umgangatho wehlabathi wolawulo lomgangatho ogubungela yonke inkqubo ukusuka kuyilo kunye nophuhliso, imveliso ukuya kwinkonzo yokuthengisa emva kokuthengisa isekiwe. Ukuthotyelwa kwe-GMP kubaboneleli be-mesotherapy ichaza ngokukodwa iimfuno ezisebenzayo ezifana nokucoceka kwendawo yemveliso, ukusebenza kwabasebenzi, izixhobo kunye nolawulo lwempahla. Ezi zimbini zisebenza kunye ukuqinisekisa ukuba imveliso iphantsi kolawulo kwinqanaba ngalinye.

Kwiimveliso eziqulethe amacandelo afana ne-hyaluronic acid, iimfuno zenkqubo yomgangatho zithe ngqo. Umzekelo, ubunzima bemolekyuli, ubumsulwa kunye nenqanaba le-endotoxin lezinto ezikrwada kufuneka balawulwe ngokungqongqo, kwaye uvavanyo olongezelelweyo lwe-biocompatibility kufuneka lwenziwe ukuqinisekisa ukhuseleko.

UVavanyo lwababoneleli kufuneka lusekelwe kumanqaku oPhicotho-zincwadi oluQinisekayo

Xa ukhetha umthengisi othobelayo, umntu kufuneka adlule ngaphaya kokuqinisekiswa okulula kwezatifikethi kwaye enze uvavanyo olubambekayo. Amanqaku aphambili ophicotho-zincwadi kufuneka abandakanye: ukuqinisekisa ukuba umda wesiqinisekiso senkqubo yolawulo lomgangatho ubandakanya iimveliso zokutofa okungenazintsholongwane; Ukuphonononga ingxelo yamva nje yokubeka iliso yokusingqongileyo kwegumbi elicocekileyo; Qinisekisa iindlela zokuvala inzala kwiimveliso kunye neengxelo ezinxulumeneyo; Ukuphonononga iziqinisekiso zomthengisi kunye nezatifikethi zokuhlolwa kwemathiriyeli ekrwada engundoqo (efana ne-hyaluronic acid); Kwaye uvavanye idatha yophando oluzinzo oluxhasa ubomi beshelufu yeemveliso zayo.

Imifuziselo yoShishino ngaphakathi kweNkqubo-sikhokelo yokuThotyelwa: Amathuba eLebhu yaBucala

INtsebenziswano yeLeyibhile yaBucala eyimpumelelo iThembela kuXanduva lokuThobela ekwabelwana ngalo

Amathuba eleyibhile ye-mesotherapy yabucala anika ithuba lokwahlulwa kwebhrendi, kodwa impumelelo yayo isekelwe ekuthotyelweni okungqongqo. Le modeli yentsebenziswano ifuna ukuba bobabini umnini-brand kunye nomvelisi bathathe ngokudibeneyo uxanduva lokuthobela. Abavelisi kufuneka baqinisekise ukuba ifomyula yemveliso, ukupakishwa kunye neelebhile zihambelana ngokupheleleyo nemimiselo ye-EU kwaye bakwazi ukubonelela ngenkxaso epheleleyo yamaxwebhu obugcisa. Abanini beempawu kufuneka baqonde umahluko ocacileyo wolawulo kwimarike ekujoliswe kuyo, ngakumbi imida yolawulo malunga namabango emveliso.

Iindlela zeMarike zibonisa ukuba ukuThotyelwa kweZakhono kuchaphazela uKhuphiswano

Uhlalutyo lweendlela zentengiso ye-mesotherapy ngo-2025 lubonisa ukuba kukho umahluko ekwamkelweni kunye nokuzimisela ukuhlawulela iimveliso ezithobelayo phakathi kwemimandla eyahlukeneyo. Kwiimarike ezivuthiweyo ezifana neNtshona Yurophu, nangona imimiselo engqongqo, abathengi bazimisele ukuhlawula i-premium kwiimveliso ezikumgangatho ophezulu kunye namaxwebhu okuthotyelwa okupheleleyo. Oku kufuna ababoneleli kungekuphela nje ukuhlangabezana nesiseko sokumakishwa kwesatifikethi se-CE, kodwa kwakhona ukuhlaziya ngokuqhubekayo ubungqina bekliniki kwaye balandele izikhokelo zokhuseleko ze-mesotherapy 2025 ukuseka ukuthembana kwexesha elide.

UYilo loThotyelo lweHlabathi: ukuCwangcisa ngaPhaya kweMarike yaseYurophu

Ukuseka ishishini lehlabathi kufuna ukuqonda izikhokelo zolawulo lweendawo ezahlukeneyo. I-EU's Medical Device Regulation idume ngokubeka iliso kumjikelezo wobomi kunye nogxininiso kubungqina bezonyango. EUnited States, indlela yokulawula yoLawulo lokuTya kunye neDrugs iyahluka. Ibeka ugxininiso ngakumbi kulawulo loyilo kwaye ayinayo ingqikelelo yokumakishwa kweCE. Iimveliso kufuneka zivunywe nge-510(k) okanye i-pre-market pre-market path ukuze iqaliswe kwimarike. Emva kweBrexit, i-UK yaseka inkqubo ezimeleyo yokumakisha i-UKCA. Nangona ngokusisiseko ihambelana ne-MDR, ifuna uvavanyo lokuthobela olwahlukileyo. Iimarike ezifana ne-Southeast Asia kunye noMbindi Mpuma zineempawu ezahlukeneyo. Basenokuzibona iziqinisekiso zamazwe ngamazwe ngokuyinxenye, kodwa zihlala zineemfuno zendawo.

Iimfuno zolawulo lwehlabathi jikelele kwiimveliso eziqulethe i-hyaluronic acid zithe ngqo. Ngokomzekelo, eUnited States, izizalisi ze-hyaluronic acid zihlelwa ngokwesiqhelo njengezixhobo zonyango zeDidi ye-III kwaye zifuna imvume engqongqo yangaphambi kwentengiso. E-China, iimveliso ezinjalo zikwahlulwa njengezixhobo zonyango lweCandelo III. Inkqubo yokubhalisa inde kwaye iimvavanyo zeklinikhi zendawo zihlala zifuneka. Ngoko ke, ukuqulunqa isicwangciso-qhinga sokuthobela 'EU +' esisekwe kweyona migangatho iphezulu (efana ne-EU MDR) kwaye inokulungiswa ngokuguquguqukayo ngokwemarike ekujoliswe kuyo ngundoqo woyilo olusebenzayo lwehlabathi.

Isiphelo kunye neSikhokelo sokuSebenza

Kwimarike ye-Mesotherapy yaseYurophu, ukuthotyelwa kwenkqubo ngundoqo wokuguqula imiqobo yokungena kwimarike kwiinzuzo ezizinzileyo zokhuphiswano. Yakha ngokuthe ngqo ukuthembana kwabathengi, inciphisa imingcipheko yokusebenza, kwaye ibeka isiseko sokwahlula uphawu.

Sicebisa ukuba uthathe la manyathelo alandelayo ukuqalisa inkqubo yokuthobela: Okokuqala, hlela ngokuchanekileyo imveliso yakho okanye imveliso ojolise kuyo ngokomthetho. Okwesibini, kuvavanya ngokucwangcisiweyo uqinisekiso lwenkqubo yolawulo lomgangatho kunye namandla athile emveliso yamaqabane anokubakho kwimveliso, ngakumbi inqanaba labo lokuthotyelwa kwe-GMP. Ekugqibeleni, xa kucwangciswa intsebenziswano yelebula yangasese, inkxaso yolawulo kunye nezakhono zolawulo lwamaxwebhu obugcisa kufuneka zithathwe njengeenqobo eziphambili zokukhetha ababoneleli.

Singakubonelela ngovavanyo lokuqala lobuchule lwendlela yokulawula. Ukuba ufuna uhlalutyo lwesikhewu sokuthotyelwa kwemveliso yakho ethile okanye isikhokelo sokufikelela kwimarike esineenkcukacha, nceda uqhagamshelane neqela lethu leengcaphephe.