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

Mahele o ka paʻi kiʻi o kā mākou palapala hōʻoia CMDCAS

Ua hōʻike ʻia he ʻokoʻa ka hōʻoia ʻana o ka lāʻau lapaʻau Kanada mai ka US (FDA) hōʻoia i mālama piha ʻia e ke aupuni i ka hoʻopaʻa inoa ʻana o nā huahana a me ka loiloi o ke aupuni ma ka pūnaewele (GMP review), ʻokoʻa hoʻi ia mai ka ʻEulopa (CE certification) i hōʻoia piha ʻia e ka ʻaoʻao ʻekolu. , hoʻokō ʻo CMDCAS i kahi ʻōnaehana maikaʻi i hōʻoia ʻia e ka hoʻopaʻa inoa aupuni me kahi loiloi ʻaoʻao ʻekolu. Pono ka ʻaoʻao ʻekolu e ʻae ʻia e ka Canadian Medical Device.

Pono nā lāʻau lapaʻau āpau i kūʻai ʻia ma ka mākeke Kanada e ʻae ʻia mai ka Canadian Medical Equipment Ministry - Canada Ministry of Health, inā i hana ʻia a i ʻole i lawe ʻia mai.

Ma ke kaʻina hoʻokolokolo o Canadian CMDCAS, pono nā mea hōʻike e hoʻokō 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 kēkelē i koi ʻia e Canadian Medical Device Regulations.

Inā makemake ʻoe e holo kūleʻa i ka hōʻoia ʻana i ka lāʻau lapaʻau Kanada, pono e ʻoi aku ka maikaʻi o nā lāʻau lapaʻau i ka maikaʻi a me ka ʻenehana a hiki ke kū i nā ʻano nānā like ʻole. Ua hōʻoia hou ʻia ka maikaʻi o ka ʻenehana maikaʻi loa o kā mākou noiʻi wela.

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Hoʻonaʻauao wela kino

Hāʻawi iā mākou iho i ka noiʻi kūʻokoʻa a hoʻomohala, hana a kūʻai aku i nā lako olakino kiʻekiʻe, koʻikoʻi mākou!

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