Kungekudala, i-State Food and Drug Administration ikhuphe iSibhengezo kwiCandelo loLawulo lweemveliso ze-Sodium hyaluronate yezoNyango (iNombolo ye-103 kwi-2022, emva koko ibizwa ngokuba yi-Nombolo ye-103 Isibhengezo).Imvelaphi kunye neziqulatho eziphambili zohlaziyo lweSibhengezo esinguNombolo 103 zimi ngolu hlobo lulandelayo:
I. Imvelaphi yohlaziyo
Kwi-2009, i-State of Food and Drug Administration yangaphambili ikhuphe iSaziso kwiCandelo loLawulo lweeMveliso ze-Sodium hyaluronate (iNombolo ye-81 ye-2009, emva koko ebizwa ngokuba yiSaziso esinguNombolo 81) ukukhokela nokulawula ukubhaliswa kunye nokulawula i-hyaluronate ye-sodium yonyango ( sodium hyaluronate) iimveliso ezinxulumeneyo.Ngophuhliso olukhawulezayo lwetekhnoloji kunye neshishini kunye nokuvela kweemveliso ezintsha, iSibhengezo se-81 asisakwazi ukuhlangabezana ngokupheleleyo neemfuno zeshishini kunye nommiselo.Ngoko ke, i-State Food and Drug Administration iququzelele ukuhlaziywa kweNombolo ye-81 isaziso.
Ii.Uhlaziyo lwemixholo ephambili
(a) Okwangoku, iimveliso ze-sodium hyaluronate (i-sodium hyaluronate) azisetyenziswanga kuphela kwiziyobisi kunye nezixhobo zonyango, kodwa zihlala zisetyenziselwa izimonyo, ukutya kunye nezinye iindawo, kwaye ezinye iimveliso zisetyenziselwa ekupheleni kweziyobisi, izixhobo zonyango kunye nezithambiso. .Ukuze ukhokele ngcono ukumiselwa kweempawu zolawulo kunye neendidi zeemveliso ezinxulumeneyo, iSaziso esinguNombolo 103 songeze umgaqo-siseko wenkcazo yophawu lolawulo lweemveliso ezisekupheleni kunye neemveliso ezidityanisiweyo zesixhobo soxubo ezibandakanya i-sodium hyaluronate (i-sodium hyaluronate) kunye nomgaqo-siseko wokuhlela imveliso yesixhobo sonyango esinxulumeneyo. , kwaye ichaze uphawu lolawulo kunye nodidi lweemveliso ezinxulumeneyo.
(2) Iimveliso zonyango ze-sodium hyaluronate zonyango lwe-urinary bladder epithelial glucosamine iziphene zokhuseleko zomaleko ziye zavunywa ukuba zithengiswe njengezixhobo zonyango lwe-Class III.Olu hlobo lwemveliso aluvunywanga ngokuhambelana nemeko yokuthengiswa kweziyobisi, ukuze kugcinwe ukuqhubeka kolawulo, ukuqhubeka nokugcina iimpawu zolawulo lwangaphambili.
(3) Xa imveliso ye-sodium ye-hyaluronate yonyango isetyenziselwa isitofu kwi-dermis nangaphantsi, kwaye isetyenziswe njengemveliso yokuzaliswa kwenaliti ukunyusa umthamo wezicubu, ukuba imveliso ayinayo izithako zonyango ezidlala i-pharmacological, i-metabolic okanye i-immunological effects, iya kulawulwa njengesixhobo sonyango seCandelo III;Ukuba imveliso iqulethe i-anesthetics yendawo kunye nezinye iziyobisi (ezifana ne-lidocaine hydrochloride, i-amino acids, iivithamini), igwetywa njengemveliso edibeneyo esekelwe kwisixhobo sonyango.
(4) Xa iimveliso zesodium hyaluronate yonyango zitofelwe kwidermis ukuphucula imeko yolusu ikakhulu ngeziphumo zokuthambisa kunye ne-hydrating yesodium hyaluronate, ukuba iimveliso aziqulathanga izithako zonyango ezidlala i-pharmacological, metabolic okanye immunological effects, ziya kuba ilawulwa ngokohlobo lwesithathu lwezixhobo zonyango;Ukuba imveliso iqulethe i-anesthetics yendawo kunye nezinye iziyobisi (ezifana ne-lidocaine hydrochloride, i-amino acids, iivithamini, njl.), kugwetywa ukuba yimveliso edibeneyo esekelwe kwisixhobo sonyango.
(5) Isaziso esinguNombolo 81 sichaza ukuba “kunyango lwe… Iimveliso ezineziphumo ezicacileyo zekhemesti ezifana nezilonda zolusu ziya kulawulwa ngokolawulo lwamachiza “.Nangona kunjalo, ngophuhliso lwesayensi kunye nobuchwepheshe kunye nokuqonda okunzulu kwe-sodium hyaluronate, ngokuqhelekileyo kukholelwa kuluntu lophando lwezenzululwazi ukuba xa i-hyaluronate ye-sodium isetyenziselwa ukugqoka kwezonyango, i-molecular weight hyaluronate ye-sodium ephezulu esetyenziswe kwizilonda zesikhumba inokubambelela phezulu. kwamanxeba esikhumba kwaye afunxe inani elikhulu leeathomu zamanzi.Ukubonelela ngendawo yokuphulukisa emanzi kwindawo yesilonda, ukwenzela ukuba kube lula ukuphulukiswa kwendawo yesilonda, umgaqo wesenzo sawo ungowona mzimba.Ezi mveliso zilawulwa njengezixhobo zonyango e-United States kunye ne-European Union.Ngoko ke, iingubo zonyango ezichazwe kwi-Bulletin 103 equkethe i-hyaluronate ye-sodium ilawulwa njengezixhobo zonyango ukuba aziqukethe izithako zonyango ezine-pharmacological, metabolic okanye immunological effects;Ukuba inokufunxwa ngokuyinxenye okanye ngokupheleleyo ngumzimba okanye isetyenziswe kumanxeba angapheliyo, kufuneka ilawulwe ngokohlobo lwesithathu lwesixhobo sonyango.Ukuba ayinakuthatyathwa ngumzimba kwaye isetyenziselwa amanxeba angapheliyo, kufuneka ilawulwe ngokohlobo lwesibini lwesixhobo sonyango.
(6) Ekubeni izinto zokulungisa izibazi ezincedisa ekuphuculeni nasekukhuseleni ukubunjwa kwe-dermatologic ye-rational scars zidweliswe kwi-"Classification of Medical Devices" 14-12-02 izixhobo zokulungisa izibazi, ziya kulawulwa ngokweCandelo II izixhobo zonyango.Xa iimveliso ezinjalo ziqukethe i-sodium hyaluronate, iipropati zabo zokulawula kunye neentlobo zolawulo azitshintshi.
7Ukhuseleko kunye nokusebenza kakuhle kwezixhobo zonyango zeCandelo I akunakuqinisekiswa ngamanyathelo olawulo.Ngoko ke, udidi lolawulo lwe-sodium hyaluronate yonyango (i-sodium hyaluronate) iimveliso phantsi kolawulo lwezixhobo zonyango akufanele zibe ngaphantsi kweCandelo II.
(8) I-sodium hyaluronate, njengesithako sokuthambisa kunye ne-hydrating, isetyenziswe kwizinto zokuthambisa.Iimveliso eziqukethe i-sodium hyaluronateezisetyenziswa eluswini, iinwele, iinzipho, imilebe kunye neminye imiphezulu yabantu ngokukhuhla, ukutshiza okanye ezinye iindlela ezifanayo ngenjongo yokucoca, ukukhusela, ukuguqula okanye ukuhombisa, kwaye azilawulwa njengeziyobisi okanye izixhobo zonyango.Iimveliso ezinjalo akufanele zifakwe ibango lokusetyenziswa kwezonyango.
(9) izinto zokuthambisa, izibulali ntsholongwane kunyeiipads zomqhaphueziqulethe izibulala-ntsholongwane ezisetyenziselwa kuphela ukubulala iintsholongwane kwesikhumba esonakeleyo kunye namanxeba aziyi kulawulwa njengamachiza okanye izixhobo zonyango.
(10) Ukuba izinto ezibonakalayo, iikhemikhali kunye ne-biological ze-hyaluronate ye-sodium eguquliweyo zihambelana nezo ze-sodium hyaluronate emva kokuqinisekiswa, iimpawu zolawulo kunye neendidi zolawulo zingaphunyezwa ngokubhekisela kwesi sibhengezo.
(11) Ukuze kucaciswe iimfuno zokuphunyezwa, imiba echaphazelekayo yesicelo sobhaliso phantsi kweemeko ezahlukeneyo zichazwe.Kwiimeko ezibandakanya ukuguqulwa kweempawu zolawulo lwemveliso okanye iindidi, ixesha lokutshintshwa kokuphunyezwa malunga ne-2 iminyaka linikezelwa ukuqinisekisa utshintsho olululo.
IMPILOiya kuhlelwa ngokungqongqo ngokwemigaqo yesizwe.Ngokuhambelana nomgaqo wokuba noxanduva kubathengi, i-Hyaluronate iya kuqhubeka nokuphuhlisa iimveliso ezintsha zokukhuthaza impilo yesikhumba.
Ixesha lokuposa: Nov-23-2022