ʻO ka mea i hala koke iho nei, ua hoʻopuka ka State Food and Drug Administration i ka Hoʻolaha no ka Management Category of Medical sodium hyaluronate products (No. 103 i 2022, ma hope iho i kapa ʻia ʻo No. 103 Announcement). ʻO ka hope a me nā mea nui o ka hoʻoponopono ʻana i ka Hoʻolaha Helu 103 penei:
I. Ke kumu o ka hooponopono
I ka makahiki 2009, ua hoʻopuka ka State Food and Drug Administration i ka leka hoʻomaopopo no ka Management Category of Medical Sodium hyaluronate Products (No. 81 o 2009, ma hope aku i kapa ʻia ʻo Notice No. 81) e alakaʻi a hoʻoponopono i ka hoʻopaʻa inoa a me ka nānā ʻana i ka sodium hyaluronate olakino ( sodium hyaluronate) huahana pili. Me ka hoʻomohala wikiwiki o ka ʻenehana a me ka ʻoihana a me ka puka ʻana o nā huahana hou, ʻaʻole hiki i ka Hoʻolaha 81 ke hoʻokō piha i nā pono o ka ʻoihana a me ka hoʻoponopono. No laila, ua hoʻonohonoho ka State Food and Drug Administration i ka hoʻoponopono hou ʻana o ka hoʻolaha helu 81.
Ii. Hoʻoponopono i nā mea nui
(a) I kēia manawa, ʻaʻole hoʻohana wale ʻia nā huahana sodium hyaluronate (sodium hyaluronate) i nā lāʻau lapaʻau a me nā mea lapaʻau, akā hoʻohana pinepine ʻia i nā mea hoʻonaninani, nā meaʻai a me nā māla ʻē aʻe, a ua hoʻohana ʻia kekahi mau huahana ma ka lihi o nā lāʻau lapaʻau, nā lāʻau lapaʻau a me nā mea hoʻonaninani. . I mea e alakaʻi maikaʻi ai i ka hoʻoholo ʻana i nā ʻano hoʻokele a me nā ʻāpana o nā huahana e pili ana, ua hoʻohui ʻo Notice No. 103 i ka manaʻo wehewehe wehewehe hoʻokele o nā huahana edge a me nā huahana hui lāʻau lapaʻau e pili ana i ka sodium hyaluronate (sodium hyaluronate) a me ke kumu hoʻohālikelike huahana pili. , a wehewehe i ke ʻano hoʻokele a me ka māhele o nā huahana pili.
(2) Ua ʻae ʻia nā huahana lāʻau sodium hyaluronate no ka mālama ʻana i nā hemahema o ka ʻōpū o ka mimi epithelial glucosamine no ka kūʻai ʻana ma ke ʻano he mau lāʻau lapaʻau Class III. ʻAʻole ʻae ʻia kēia ʻano huahana e like me ke kūlana o ka kūʻai ʻana i ka lāʻau lapaʻau, i mea e mālama ai i ka hoʻomau o ka hoʻokele, e hoʻomau i ka mālama ʻana i nā ʻano hoʻokele kumu.
(3) Ke hoʻohana ʻia ka lāʻau lapaʻau sodium hyaluronate no ka injection i loko o ka dermis a ma lalo, a hoʻohana ʻia ma ke ʻano he mea hoʻopihapiha hoʻopihapiha e hoʻonui ai i ka nui o ka kiko, inā ʻaʻole i loaʻa i ka huahana nā mea lāʻau lapaʻau e pāʻani i ka pharmacological, metabolic a i ʻole immunological effects. e lawelawe ʻia ma ke ʻano he lāʻau lapaʻau papa III; Inā loaʻa i ka huahana nā anesthetics kūloko a me nā lāʻau lapaʻau ʻē aʻe (e like me ka lidocaine hydrochloride, nā amino acids, nā huaora), ua manaʻo ʻia ʻo ia ka huahana hui pū ʻia me ka lāʻau lapaʻau.
(4) Ke hoʻokomo ʻia nā huahana sodium hyaluronate i loko o ka dermis e hoʻomaikaʻi ai i ke ʻano o ka ʻili ma o ka moisturizing a me ka hydrating hopena o ka sodium hyaluronate, inā ʻaʻole i loaʻa i nā huahana nā mea lāʻau lapaʻau e pāʻani ana i ka pharmacological, metabolic a i ʻole nā hopena immunological. lawelawe ʻia e like me ke kolu o nā ʻano lāʻau lapaʻau; Inā loaʻa i ka huahana nā anesthetics kūloko a me nā lāʻau lapaʻau ʻē aʻe (e like me ka lidocaine hydrochloride, nā waikawa amino, nā huaora, a me nā mea ʻē aʻe), ua manaʻo ʻia ʻo ia ka huahana hui pū ʻia me ka lāʻau lapaʻau.
(5) Hoʻolaha No. 81 e ʻōlelo ʻia "no ka mālama ʻana i… ʻO nā huahana me nā hopena lāʻau lapaʻau paʻa e like me ka ʻeha ʻili e mālama ʻia e like me ka hoʻokele lāʻau ". Eia nō naʻe, me ka hoʻomohala ʻana o ka ʻepekema a me ka ʻenehana a me ka hoʻonui ʻana i ka ʻike o ka sodium hyaluronate, ua manaʻoʻiʻo ʻia i loko o ke kaiāulu noiʻi ʻepekema i ka wā e hoʻohana ʻia ai ka sodium hyaluronate i nā lole lapaʻau, hiki ke hoʻopili ʻia ka sodium hyaluronate kiʻekiʻe i nā ʻeha o ka ʻili. o na eha ili a komo i ka nui o na mole wai. No ka hoʻolako ʻana i kahi ʻano hoʻōla pulu no ka ʻili o ka ʻeha, i mea e maʻalahi ai ka hoʻōla ʻana o ka ʻili o ka ʻeha, ʻo ke kumu o kāna hana ke kino. Hoʻoponopono ʻia kēia mau huahana e like me nā lāʻau lapaʻau ma United States a me ka European Union. No laila, hoʻoponopono ʻia nā lole lapaʻau i kuhikuhi ʻia ma Bulletin 103 i loaʻa ka sodium hyaluronate e like me nā mea lapaʻau inā ʻaʻole i loaʻa nā mea lāʻau lapaʻau i loaʻa nā hopena pharmacological, metabolic a immunological; Inā hiki ke hoʻopili ʻia e ke kino a i ʻole hoʻohana ʻia no nā ʻeha mau, pono e mālama ʻia e like me ke kolu o nā ʻano lāʻau lapaʻau. Inā ʻaʻole hiki ke hoʻopili ʻia e ke kino a hoʻohana ʻia no nā ʻeha non-chronic, pono e mālama ʻia e like me ke ʻano ʻelua o ka lāʻau lapaʻau.
(6) No ka mea, ua helu ʻia nā mea hana hoʻoponopono ʻili e kōkua i ka hoʻomaikaʻi ʻana a me ka pale ʻana i ka hoʻokumu ʻana o nā ʻōpala dermatologic rational ma "Classification of Medical Devices" 14-12-02 Scar repair materials, e mālama ʻia lākou e like me ka Category II. Ke loaʻa i kēlā mau huahana ka sodium hyaluronate, ʻaʻole loli ko lākou mau waiwai hoʻokele a me nā ʻāpana hoʻokele.
(7) Lawe ʻia ka sodium hyaluronate (sodium hyaluronate) mai nā ʻiʻo holoholona a i ʻole i hana ʻia e ka microbial fermentation, aia kekahi mau pilikia. ʻAʻole hiki ke hōʻoiaʻiʻo ʻia ka palekana a me ka maikaʻi o nā lāʻau lapaʻau Category I e nā ana hoʻoponopono. No laila, ʻaʻole pono e haʻahaʻa ka māhele hoʻokele o nā huahana sodium hyaluronate (sodium hyaluronate) ma lalo o ka hoʻokele ʻana o nā mea lapaʻau ma mua o ka Māhele II.
(8) Hoʻohana ʻia ka sodium hyaluronate, ma ke ʻano he moisturizing a me ka hydrating ingredient, i nā mea hoʻonaninani.Nā huahana me ka sodium hyaluronatei hoʻohana ʻia i ka ʻili, ka lauoho, nā kui, nā lehelehe a me nā mea ʻē aʻe o ke kanaka ma o ka hamo ʻana, kāpīpī a i ʻole nā ʻano like ʻole no ka hoʻomaʻemaʻe, pale ʻana, hoʻololi a hoʻonani ʻia, ʻaʻole i lawelawe ʻia ma ke ʻano he lāʻau lapaʻau a i ʻole nā mea lapaʻau. ʻAʻole pono e koi ʻia ia mau huahana no ka hoʻohana olakino.
(9) lotions, disinfectants apulupulu pulupuluʻAʻole e lawelawe ʻia nā lāʻau lapaʻau a i ʻole nā mea lapaʻau i loaʻa nā disinfectants i hoʻohana wale ʻia no ka disinfection o ka ʻili poino a me nā ʻeha.
(10) Inā kūlike nā waiwai kino, kemika a me ke olaola o ka sodium hyaluronate i hoʻololi ʻia me ka sodium hyaluronate ma hope o ka hōʻoia ʻana, hiki ke hoʻokō ʻia nā ʻano hoʻokele a me nā ʻāpana hoʻokele ma ka nānā ʻana i kēia Hoʻolaha.
(11) No ka wehewehe ʻana i nā koi hoʻokō, ua ʻōlelo ʻia nā mea pili o ka noi inoa inoa ma lalo o nā kūlana like ʻole. No nā kūlana e pili ana i ka hoʻololi ʻana o nā ʻano hoʻokele waiwai a i ʻole nā waeʻano, hāʻawi ʻia ka manawa hoʻololi hoʻokō ma kahi o 2 mau makahiki e hōʻoia i ka hoʻololi maʻalahi.
HOOLAHA OLAe hoʻokaʻawale ʻia e like me nā lula aupuni. E like me ke kumu o ke kuleana no nā mea kūʻai aku, e hoʻomau ka Hyaluronate i ka hoʻomohala ʻana i nā huahana hou e hoʻolaha i ke olakino ʻili.
Ka manawa hoʻouna: Nov-23-2022