Pehea e nānā ai i ka ʻoiaʻiʻo o nā maka lapaʻau

OIP-Cth
No ka mea ua hoʻopaʻa inoa ʻia a hoʻopaʻa ʻia nā masks lapaʻau e like me nā lāʻau lapaʻau i ka hapa nui o nā ʻāina a i ʻole nā ​​ʻāina, hiki i nā mea kūʻai ke hoʻokaʻawale hou iā lākou ma o ka hoʻopaʻa inoa ʻana a me ka ʻike pili.Eia kekahi laʻana o Kina, ʻAmelika Hui Pū ʻIa a me ʻEulopa.

Kina
No ka papa ʻelua o nā lāʻau lapaʻau ma Kina, ua hoʻopaʻa inoa ʻia a mālama ʻia e ka ʻoihana hoʻoponopono lāʻau lapaʻau kūloko, a hiki ke nīnau ʻia e nā mea lapaʻau e nīnau i ka helu helu komo.ʻO ka loulou:

http://www.nmpa.gov.cn/WS04/CL2590/.

ʻAmelika Hui Pū ʻIa
Hiki ke nīnau ʻia nā huahana mask i ʻae ʻia e ka US FDA ma o kāna pūnaewele mana e nānā i ka helu palapala hoʻopaʻa inoa, ʻo ka loulou:

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm

Eia kekahi, e like me ka POLICY hou loa o ka FDA, ua ʻike ʻia i kēia manawa he Mask of Chinese Standards ma lalo o kekahi mau kūlana, a ʻo ka loulou o kāna ʻoihana ʻae ʻia:

https://www.fda.gov/media/136663/download.

Hui ʻEulopa
Hiki ke hana ʻia ka hoʻokuʻu ʻana i nā masks lapaʻau EU ma o nā kino i ʻae ʻia, kahi i ʻae ʻia e ke kino i ʻae ʻia e ka EU Medical Device Directive 93/42/EEC (MDD):

https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=13.

ʻO ka helu wahi nīnau nīnau kino i ʻae ʻia e ka EU Medical Device Regulation EU 2017/745 (MDR):

https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34.


Ka manawa hoʻouna: Apr-17-2022