Hoʻokuʻu aku i ʻAmelika Hui Pū ʻIa
ʻO ka US Food and Drug Administration (FDA) e kuhikuhi ana i nā mea lapaʻau, nā meaʻai, ka waiʻona, nā lāʻau lapaʻau a me nā hale hana ʻē aʻe ma waho o ʻAmelika Hui Pū ʻIa pono e hoʻopaʻa inoa ʻia a pono ke koho ʻia kahi ʻelele US ma mua o ka helu ʻia ʻana ma United States.
21CFR Māhele 807.40 (A) ʻōlelo ʻo kēlā me kēia mea hana ʻAmelika ʻē aʻe i hana i ka hana, hoʻomākaukau, hui pū ʻana a i ʻole ka hana ʻana i nā lāʻau lapaʻau i hoʻopau ʻia a me ka lawe ʻana mai i nā huahana i ʻAmelika e pono e hoʻokō i ka Establishment Registration and Medical Device Listing.I ka wā e hoʻopaʻa inoa ai i ka hale hana, pono ka mea hana e hōʻike i ka ʻike o ka ʻelele US i FDA ma ke ʻano uila ma ka ʻōnaehana hoʻopaʻa inoa a me ka papa inoa (FURLS system), me ka inoa, helu wahi, kelepona, fax a me ka leka uila o ka ʻelele US.
No kēlā me kēia huahana, pono nā ʻoihana e hoʻopaʻa inoa a papa inoa i nā huahana.
No nā huahana Papa I (ma kahi o 47%), hoʻohana ʻia ka Mana Nui.Hiki i ka hapa nui o nā huahana ke komo i ka mākeke US ma ke kākau inoa ʻana, ka papa inoa ʻana a me ka hoʻokō ʻana i nā kikoʻī GMP (kakaikahi o lākou i hoʻokuʻu ʻia mai ka GMP, a he kakaikahi o nā huahana i mālama ʻia e pono e waiho i nā noi 510 (K) i ka FDA, ʻo ia hoʻi PMN (Premarket Notification. ));
Hoʻokuʻu aku i Iapana
Pono nā hui lāʻau lapaʻau e makemake ana e kau i kā lākou huahana ma ka mākeke Iapana e hoʻokō i nā koi o ka Japanese Pharmaceutical And Medical Device Act (PMD Act).
Inā makemake nā hui Lapaʻau Lapaʻau e hoʻokomo i kā lākou mau huahana i ka mākeke Iapana, pono lākou e hoʻokō i nā koi o ke kānāwai lāʻau lapaʻau a me nā lāʻau lapaʻau (PMD Act) o Iapana.
ʻO ka Pharmaceutical and Medical Devices Agency (PMDA), kahi keʻena o lalo o ka Ministry of Health, Labor and Welfare (MHLW), ua hoʻopuka pū i kahi helu liʻiliʻi o nā lula ma ka ʻōlelo Pelekania.Eia nō naʻe, ʻo nā pilikia ʻōlelo a me nā kaʻina hana hōʻoia paʻakikī he wahi paʻakikī no ka hoʻopaʻa inoa ʻana i nā mea lapaʻau ma Iapana.
Ma lalo o nā koi o ke kānāwai PMD, koi ka ʻōnaehana hoʻopaʻa inoa ʻo TOROKU i nā mea hana hale e hoʻopaʻa inoa i ka ʻike hale hana me nā mana kūpono kūloko i ʻae ʻia e ke aupuni, me ka hoʻolālā huahana, hana a me ka ʻike kaʻina hana nui;Pono nā mea hana haole e hoʻopaʻa inoa i ka ʻike mea hana me PMDA.
Ma ke noi o ke kānāwai PMD, koi ʻo Toroku Registration System i nā mea hana hale e hoʻopaʻa inoa i ka ʻike hale hana me nā mana kūloko i ʻae ʻia e ke aupuni, me ka hoʻolālā huahana, hana a me ka ʻike kaʻina hana nui;Pono nā mea hana haole e hoʻopaʻa inoa i ka ʻike mea hana me PMDA.
Hoʻokuʻu aku i Korea Hema
ʻO ka Ministry of Health Welfare (MHW) ma South Korea, i kapa ʻia ʻo Ministry of Health no ka pōkole, ʻo ia ke kuleana nui no ka mālama ʻana i nā meaʻai, nā lāʻau lapaʻau, nā mea hoʻonaninani a me nā mea lapaʻau, a ʻo ia ka ʻoihana mālama ola kino.Wahi a ka Law Device Law, ʻo ka Ministry of Food and Drug Safety (MFDS) ma lalo o ka Ministry of Health and Welfare o South Korea ke kuleana no ka nānā ʻana i nā mea lapaʻau.
Hoʻokaʻawale ke Kānāwai Lapaʻau Lapaʻau Korea i nā mea lapaʻau i ʻehā mau ʻāpana (I, II, III, IV), i like loa me ka hoʻohālikelike ʻana o ka European Union i nā mea lapaʻau.
Hoʻokaʻawale ke kānāwai o nā lāʻau lapaʻau Korea i nā lāʻau lapaʻau i ʻehā mau ʻāpana (I, II, III a me IV), i like loa me ka hoʻokaʻawale ʻana o ka European Union i nā mea lapaʻau.
Papa I: nā lāʻau lapaʻau me ka pilikia liʻiliʻi;
Papa II: nā lāʻau lapaʻau me ka pilikia haʻahaʻa;
Papa III: nā lāʻau lapaʻau me ka pōʻino kūpono;
Papa IV: Nā mea lapaʻau pilikia nui.
ʻO ke kumu hoʻohālikelike o nā lāʻau lapaʻau: ke kēkelē pilikia, ka wahi pili a me ka manawa me ke kino kanaka, palekana a me ka pono o nā huahana.
E hōʻoia ʻia nā lako Papa I a me II e ka "Medical Device Information Technology Support Center (MDITAC)", a e ʻae ʻia kekahi mau lako papa II (mea hana hou), Class III a me Class IV e ka Korean Food and Drug Safety Administration.
Pono nā lāʻau lapaʻau āpau i lawe ʻia aku i Australia e noi no ka hoʻopaʻa inoa TGA.ʻO TGA ka pōkole o Therapeutic Goods Administration.ʻO kona inoa piha ka Therapeutic Goods Administration.ʻO ia ke keʻena kiaʻi o nā huahana therapeutic (me nā lāʻau lapaʻau, nā lāʻau lapaʻau, ka ʻenehana genetic a me nā huahana koko) ma Australia.
ʻO ka wehewehe ʻana o nā lāʻau lapaʻau ma Australia kahi kokoke i ka CE o EU, a ʻo ka hoʻohālikelike ʻana ke kūlike.ʻOkoʻa mai ka US FDA, ʻaʻole hoʻoponopono ʻia nā ʻano holoholona e TGA.E like me FDA, pono ʻoe e kuhikuhi i ka hanauna
Nā Koina Maka
ʻO NIOSH (National Institute of Occupational Safety and Health) Hoʻokaʻawale i kāna mau mea hoʻomaha ʻāpana i hōʻoia ʻia i loko o 9 mau ʻāpana e like me nā kānāwai HHS.Hoʻohana ʻia ka hōʻoia kikoʻī e ka Npptl Laboratory ma lalo o NIOSH.
Ma ʻAmelika Hui Pū ʻIa, e like me ka liʻiliʻi o ka hoʻoheheʻe ʻana i nā mea kānana, hiki ke hoʻokaʻawale ʻia nā masks i ʻekolu mau papa - N, R, P.
Hiki i nā Masks Papa N ke kānana wale i nā ʻāpana ʻaʻaʻole, e like me ka lepo, ka noe ʻakika, ka noe pena, ka microorganism, a me nā mea ʻē aʻe.
He kūpono wale nō ʻo R Mask no ka kānana ʻana i nā ʻāpana aila a me nā ʻāpana ʻaila ʻole, akā ʻaʻole i ʻoi aku ka manawa o ka hoʻohana palena ʻia no nā ʻaila ʻaila.
Hiki i nā Mass Papa P ke kānana i nā ʻāpana ʻaila ʻole a me nā ʻāpana ʻaila.ʻO nā ʻāpana ʻaila e like me ka uahi aila, ʻaila noe, etc.
E like me ka ʻokoʻa o ka hoʻomaʻemaʻe ʻana, aia nā ʻokoʻa 90,95100, ʻo ia hoʻi, e pili ana i ka liʻiliʻi o ka hoʻomaʻemaʻe ʻana o 90%, 95%, 99.97% ma lalo o nā kūlana hoʻāʻo i hōʻike ʻia ma ke kūlana.
ʻAʻole ʻo N95 he inoa huahana kikoʻī.E like me ka lōʻihi o ka huahana i ka N95 Standard a hala i ka NIOSH Review, hiki ke kapa ʻia ʻo "N95 Mask".
Nuhōlani:
Nā ʻike e pono ai (Kūpono)
Bill Of Lading, Papa Hoʻopili, Invoice
Nā Koina Maka
As / NZS 1716: 2012 He Paʻa Paʻa Paʻa ʻAha ma Australia a me Aotearoa.Pono ke kaʻina hana a me ka ho'āʻo ʻana i nā huahana pili i kēia ʻōlelo kikoʻī.
Hōʻike kēia maʻamau i nā kaʻina hana a me nā mea pono e hoʻohana ʻia i ke kaʻina hana ʻana o nā mea hoʻomaha ʻāpana, a me ka hoʻoholo ʻana a me nā hopena hana e hōʻoia ai i kā lākou hoʻohana palekana.
Leka pilikino:
I kēia manawa, ʻaʻole e hoʻomalu ʻia ka E-Commerce Cross-Border i ka hoʻokuʻu ʻana aku i nā mea anti-epidemic e like me nā masks.Inā ʻo ka helu o nā masks i loko o kahi kūpono kūpono, hiki ke hoʻouna ʻia nā masks i nā ʻāina ʻē e ka leka pilikino.ʻOiai ʻo ka nui o nā ʻāina i hoʻōki i ka hoʻouna ʻana i ka leka iā Kina, ʻaʻole lākou e hoʻōki i ka loaʻa ʻana o ka leka a me ka hoʻouna ʻana mai Kina.Eia nō naʻe, ʻokoʻa nā koi o kēlā me kēia ʻāina, no laila e ʻoluʻolu e nīnau i nā koi kikoʻī o ka ʻāina ma mua o ka leka uila.
ʻŌlelo a ka Lunahooponopono:
1. No ka mea ʻokoʻa nā koi o kēlā me kēia ʻāina no nā masks i lawe ʻia mai, pono ʻoe e kamaʻilio me ka hui ʻoihana kūloko a i ʻole ka hui lawe ʻana ma mua o ka lawe ʻana aku e pale aku i ka pilikia o nā mea i kāohi ʻia a hoʻihoʻi ʻia.
2. Pono ka helu o nā masks no ka hoʻohana ponoʻī ʻana a me ka lawe ʻana aku i loko o kahi ākea kūpono.Ina nui ka helu, e hopu ia e na dute o na aina e.
3. I kēia manawa, ʻaʻole i hoʻihoʻi hou ʻia ka mana o ka lawe ʻana i ka ea a me ke kai, no laila ua lōʻihi ka manawa o ka lawe ʻana i kēia manawa.Pono nā kānaka a pau e noʻonoʻo i ka hoʻololi ʻana i ka helu waybill ma hope o ka hoʻouna ʻana, a e hoʻomanawanui pū kekahi.I ka wā ʻaʻohe hana ʻino, ʻaʻole e hoʻopaʻa ʻia a hoʻihoʻi ʻia.
Pa'i hou i keia 'atikala.Inā he kuhi hewa paha, e ʻoluʻolu e kelepona mai iā mākou no ka hoʻoponopono ʻana
Ka manawa hoʻouna: Mar-16-2020
