In vitro diagnostic reagent hoʻopaʻa inoa / waihona waihona
ʻO ke ʻano mua o ka in vitro diagnostic reagents e pili i ka hoʻokele moʻolelo huahana.ʻO ka papa II a me ka Class Ill in vitro diagnostic reagents e hoʻokō ʻia i ka hoʻokele inoa inoa huahana.
E hoʻokomo i ka ʻano mua o ka in vitro diagnostic reagents no ka waiho ʻana, a na ka mea faila e waiho i nā mea waihona i ka National Medical Products Administration.E nānā ʻia nā mea hoʻoponopono diagnostic in vitro i lawe ʻia mai ka Papa II a me ka Papa 111 e ka National Medical Products Administration, a ma hope o ka ʻae ʻia, e hoʻopuka ʻia kahi palapala hoʻopaʻa inoa mea lapaʻau.

ʻOihana hoʻokele kikowaena
ʻO ka National Medical Products Administration ke kuleana o ka hoʻopaʻa inoa ʻana a me ka hoʻokele ʻana o ka in vitro diagnostic reagents ma ka ʻāina holoʻokoʻa, hoʻonohonoho i ka loiloi a me ka ʻae ʻia o ka lawe ʻia ʻana o ka lua a me ke kolu o nā ʻano in vitro diagnostic reagents, a me nā moʻolelo a me ka nānā ʻana a me ka hoʻokele ʻana i nā ʻano ʻano mua i lawe ʻia mai. vitro diagnostic reagents e like me ke kānāwai;
ʻO ka National Medical Products Administration Medical Device Technical Evaluation Center ke kuleana no ka loiloi ʻenehana o ka noi no ka hoʻopaʻa inoa ʻana, hoʻololi o ka hoʻopaʻa inoa ʻana, hoʻohou o ka hoʻopaʻa inoa, etc.

ʻO ka māhele hoʻokele o "Administrative Measures"
I ke kaʻina o ka wānana maʻi, ka pale ʻana, ka ʻike, ka nānā ʻana i ka mālama ʻana, ka nānā ʻana i ka prognosis a me ka loiloi kūlana olakino, reagents, kits, calibrators, nā huahana mana maikaʻi a me nā huahana ʻē aʻe i hoʻohana ʻia no ka ʻike in vitro o nā laʻana kanaka hiki ke hoʻohana wale ʻia a i hui pū ʻia me nā mea kani. , nā mea hana, nā lako a i ʻole nā ​​ʻōnaehana.ʻAʻole i loko o ke ʻano o ka hoʻoponopono ʻana i nā mea hoʻopaʻa diagnostic in vitro no ka nānā ʻana i ke kumu koko a me nā reagents diagnostic in vitro i hōʻailona ʻia me nā radionuclides.