Matanho ekutonga ekunyoresa uye kufaira kwe in vitro diagnostic reagents (zvino zvinonzi "Administrative Measures")

In vitro diagnostic reagent kunyoresa / faira agency
Mhando yekutanga ye in vitro diagnostic reagents ichave iri pasi pechigadzirwa rekodhi manejimendi.Kirasi II uye Kirasi Ill in vitro diagnostic reagents ichave iri pasi pechigadzirwa kunyoresa manejimendi.
Ngenisa iyo yekutanga mhando ye in vitro diagnostic reagents yekuisa, uye iyo faira ichaendesa zvinyorwa zvemafaira kuNational Medical Products Administration.Yakatorwa Kirasi II uye Kirasi 111 in vitro diagnostic reagents ichaongororwa neNational Medical Products Administration, uye mushure memvumo, gwaro rekunyoresa mudziyo wekurapa richapihwa.

Centralized management department
National Medical Products Administration inoona nezve kunyoreswa uye kufaira manejimendi e in vitro diagnostic reagents munyika yese, inoronga ongororo uye kubvumidzwa kwemhando dzepiri neyechitatu dzakatengwa kunze kwenyika dze in vitro diagnostic reagents, uye marekodhi pamwe nekutarisa kwakabatana uye manejimendi ekutanga ekutanga mhando ye in. vitro diagnostic reagents maererano nemutemo;
National Medical Products Administration Medical Device Technical Evaluation Center ine basa rekuongorora kwehunyanzvi kwechikumbiro chekunyoresa, shanduko yekunyoresa, kuvandudzwa kwekunyoresa, nezvimwe zveKirasi Ill kuChina uye yakaunzwa kunze Kirasi II uye Kirasi Ill in vitro diagnostic reagents.

Chikamu chekutungamira che "Administrative Measures"
Mukuita kwekufanotaura kwechirwere, kudzivirira, kuongororwa, kuongororwa kwekurapa, kucherechedzwa kwekufungidzira uye kuongororwa kwehutano hwehutano, reagents, kits, calibrator, zvigadzirwa zvekudzora mhando uye zvimwe zvigadzirwa zvinoshandiswa in vitro kucherechedzwa kwemasamples evanhu zvinogona kushandiswa chete kana kusanganiswa nezviridzwa. , midziyo, midziyo kana masisitimu.In vitro diagnostic reagents yekuongororwa kweropa sosi uye in vitro diagnostic reagents zvakanyorwa neradionuclides hazvisi mukati mechikamu chemaitiro ekutonga.


Nguva yekutumira: Oct-22-2021