Mei 25, 2017, ua noiʻi kūʻokoʻa ʻia ka ʻimi mahana consumable lapaʻau a hoʻomohala ʻia e Shenzhen Med-linket Medical Electronics Co., Ltd. i ka palapala hōʻoia CMDCAS Kanada

ʻĀpana o ka kiʻi o kā mākou palapala hōʻoia CMDCAS

Ua hōʻike ʻia he ʻokoʻa ka palapala hōʻoia no nā hāmeʻa lapaʻau Kanada mai ka palapala hōʻoia o ʻAmelika Hui Pū ʻIa (FDA) i mālama piha ʻia e ke aupuni ma ke kau inoa ʻana i nā huahana a me ka loiloi ma ka pūnaewele o ke aupuni (loiloi GMP), he ʻokoʻa nō hoʻi ia mai ka palapala hōʻoia ʻEulopa (palapala hōʻoia CE) i hōʻoia piha ʻia e ka ʻaoʻao ʻekolu, hoʻokō ʻo CMDCAS i kahi ʻōnaehana maikaʻi i hōʻoia ʻia e ke kau inoa aupuni a me kahi loiloi ʻaoʻao ʻekolu. Pono hoʻi e ʻae ʻia ka ʻaoʻao ʻekolu e ka Hāmeʻa Lapaʻau Kanada.

Pono nā lako lapaʻau a pau i kūʻai ʻia ma ka mākeke Kanada e loaʻa ka ʻae mai ke Keʻena Lapaʻau Lapaʻau Kanada - ke Keʻena Ola o Kanada, inā paha he mea i hana ʻia ma kahi kūloko a i ʻole i lawe ʻia mai.

Ma ke kaʻina hana loiloi o ka CMDCAS Kanada, pono e hoʻokō nā hōʻike i nā koi o ka ʻōnaehana hoʻokele maikaʻi maʻamau ISO 13485/8:199 a i ʻole ISO 13485:2003 a pono e hoʻokō i ke kekelē i koi ʻia e nā Canadian Medical Device Regulations.

Inā makemake ʻoe e hala pono i ka palapala hōʻoia no nā lako lapaʻau Kanada, pono nā lako lapaʻau e ʻoi aku ka maikaʻi a me ka ʻenehana a hiki ke kū i nā nānā like ʻole. ʻO ka holomua maʻalahi ma ka palapala hōʻoia CMDCAS Kanada i hōʻoia hou i kā mākou ʻano loea maikaʻi loa o kā mākou probe mahana.

Ka ʻimi mahana lua

ʻIke Mahana Kino

Hoʻolaʻa iā mākou iho e noiʻi kūʻokoʻa a hoʻomohala, hana a kūʻai aku i nā lako lapaʻau kiʻekiʻe, koʻikoʻi mākou!

E maʻalahi i nā limahana lapaʻau, olakino nā kānaka

Hoʻāʻo mau mākou i ka maikaʻi loa