Matakan gudanarwa don yin rajista da shigar da kayan aikin bincike na in vitro (daga nan ake kira "Ma'auni na Gudanarwa")

In vitro diagnostic reagent rajista / shigar da hukumar
Nau'in farko na in vitro diagnostic reagents zai kasance ƙarƙashin sarrafa rikodin samfur.Class II da Class Ill in vitro diagnostic reagents za su kasance ƙarƙashin kulawar rajistar samfur.
Shigo da nau'in farko na in vitro diagnostic reagents don yin rajista, kuma mai yin fayil ɗin zai gabatar da kayan tattarawa ga Hukumar Kula da Kayayyakin Kiwon Lafiya ta ƙasa.Masu shigo da kaya na II da Class 111 in vitro diagnostic reagents za a bincika ta Hukumar Kula da Kayayyakin Kiwon Lafiya ta Kasa, kuma bayan amincewa, za a ba da takardar shaidar rajistar na'urar likita.

Sashen gudanarwa na tsakiya
Hukumar Kula da Kayayyakin Kiwon Lafiya ta Kasa ita ce ke kula da rajista da gudanar da sarrafa kayan aikin in vitro diagnostic reagents a duk faɗin ƙasar, tana tsara bita da yarda da shigo da nau'ikan na biyu da na uku na in vitro diagnostic reagents, da bayanai da kulawa da alaƙa da sarrafa nau'in in vitro na farko da aka shigo da su. vitro diagnostic reagents bisa ga doka;
Cibiyar Nazarin Fasaha ta Na'urar Kula da Na'urar Kiwon Lafiya ta ƙasa ce ke da alhakin kimanta fasaha na aikace-aikacen rajista, canjin rajista, sabuntawar rajista, da sauransu na rashin lafiya na Class II a China da shigo da Class II da Class Ill in vitro diagnostic reagents.

Rukunin gudanarwa na "Ma'aunin Gudanarwa"
A cikin aiwatar da tsinkayar cutar, rigakafin, ganewar asali, kulawar jiyya, lura da hangen nesa da ƙimar ƙimar kiwon lafiya, reagents, kits, calibrators, samfuran kula da inganci da sauran samfuran da ake amfani da su don gano samfuran samfuran in vitro za a iya amfani da su kadai ko a hade tare da kayan kida. , kayan aiki, kayan aiki ko tsarin.In vitro diagnostic reagents don tantance tushen jini da in vitro diagnostic reagents da aka yiwa lakabi da radionuclides basa cikin iyakokin matakan gudanarwa.


Lokacin aikawa: Oktoba-22-2021